Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children

Darren Owens; Simon Watkinson; Jayne E Harrison; Sarah Turner; Helen V Worthington

doi:10.1002/14651858.CD003451.pub3

. 2024 Apr 10;2024(4):CD003451. doi: 10.1002/14651858.CD003451.pub3

Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children

Darren Owens ¹, Simon Watkinson ², Jayne E Harrison ^1,^✉, Sarah Turner ¹, Helen V Worthington ³

Editor: Cochrane Oral Health Group

PMCID: PMC11005087 PMID: 38597341

Abstract

Background

Prominent lower front teeth (Class III malocclusion) may be due to jaw or tooth position or both. The upper jaw (maxilla) can be too far back or the lower jaw (mandible) too far forward; the upper front teeth (incisors) may be tipped back or the lower front teeth tipped forwards. Orthodontic treatment uses different types of braces (appliances) fitted inside or outside the mouth (or both) and fixed to the teeth. A facemask is the most commonly reported non‐surgical intervention used to correct Class III malocclusion. The facemask rests on the forehead and chin, and is connected to the upper teeth via an expansion appliance (known as 'rapid maxillary expansion' (RME)). Using elastic bands placed by the wearer, a force is applied to the top teeth and jaw to pull them forwards and downward. Some orthodontic interventions involve a surgical component; these go through the gum into the bone (e.g. miniplates). In severe cases, or if orthodontic treatment is unsuccessful, people may need jaw (orthognathic) surgery as adults. This review updates one published in 2013.

Objectives

To assess the effects of orthodontic treatment for prominent lower front teeth in children and adolescents.

Search methods

An information specialist searched four bibliographic databases and two trial registries up to 16 January 2023. Review authors screened reference lists.

Selection criteria

We looked for randomised controlled trials (RCTs) involving children and adolescents (16 years of age or under) randomised to receive orthodontic treatment to correct prominent lower front teeth (Class III malocclusion), or no (or delayed) treatment.

Data collection and analysis

We used standard methodological procedures expected by Cochrane. Our primary outcome was overjet (i.e. prominence of the lower front teeth); our secondary outcomes included ANB (A point, nasion, B point) angle (which measures the relative position of the maxilla to the mandible).

Main results

We identified 29 RCTs that randomised 1169 children (1102 analysed). The children were five to 13 years old at the start of treatment. Most studies measured outcomes directly after treatment; only one study provided long‐term follow‐up. All studies were at high risk of bias as participant and personnel blinding was not possible.

Non‐surgical orthodontic treatment versus untreated control

We found moderate‐certainty evidence that non‐surgical orthodontic treatments provided a substantial improvement in overjet (mean difference (MD) 5.03 mm, 95% confidence interval (CI) 3.81 to 6.25; 4 studies, 184 participants) and ANB (MD 3.05°, 95% CI 2.40 to 3.71; 8 studies, 345 participants), compared to an untreated control group, when measured immediately after treatment. There was high heterogeneity in the analyses, but the effects were consistently in favour of the orthodontic treatment groups rather than the untreated control groups (studies tested facemask (with or without RME), chin cup, orthodontic removable traction appliance, tandem traction bow appliance, reverse Twin Block with lip pads and RME, Reverse Forsus and mandibular headgear).

Longer‐term outcomes were measured in only one study, which evaluated facemask. It presented low‐certainty evidence that improvements in overjet and ANB were smaller at 3‐year follow‐up than just after treatment (overjet MD 2.5 mm, 95% CI 1.21 to 3.79; ANB MD 1.4°, 95% CI 0.43 to 2.37; 63 participants), and were not found at 6‐year follow‐up (overjet MD 1.30 mm, 95% CI ‐0.16 to 2.76; ANB MD 0.7°, 95% CI ‐0.74 to 2.14; 65 participants). In the same study, at the 6‐year follow‐up, clinicians made an assessment of whether surgical correction of participants' jaw position was likely to be needed in the future. A perceived need for surgical correction was observed more often in participants who had not received facemask treatment (odds ratio (OR) 3.34, 95% CI 1.21 to 9.24; 65 participants; low‐certainty evidence).

Surgical orthodontic treatment versus untreated control

One study of 30 participants evaluated surgical miniplates, with facemask or Class III elastics, against no treatment, and found a substantial improvement in overjet (MD 7.96 mm, 95% CI 6.99 to 8.40) and ANB (MD 5.20°, 95% CI 4.48 to 5.92; 30 participants). However, the evidence was of low certainty, and there was no follow‐up beyond the end of treatment.

Facemask versus another non‐surgical orthodontic treatment

Eight studies compared facemask or modified facemask (with or without RME) to another non‐surgical orthodontic treatment. Meta‐analysis did not suggest that other treatments were superior; however, there was high heterogeneity, with mixed, uncertain findings (very low‐certainty evidence).

Facemask versus surgically‐anchored appliance

There may be no advantage of adding surgical anchorage to facemasks for ANB (MD ‐0.35, 95% CI ‐0.78 to 0.07; 4 studies, 143 participants; low‐certainty evidence). The evidence for overjet was of very low certainty (MD ‐0.40 mm, 95% CI ‐1.30 to 0.50; 1 study, 43 participants).

Facemask variations

Adding RME to facemask treatment may have no additional benefit for ANB (MD ‐0.15°, 95% CI ‐0.94 to 0.64; 2 studies, 60 participants; low‐certainty evidence). The evidence for overjet was of low certainty (MD 1.86 mm, 95% CI 0.39 to 3.33; 1 study, 31 participants).

There may be no benefit in terms of effect on ANB of alternating rapid maxillary expansion and constriction compared to using expansion alone (MD ‐0.46°, 95% CI ‐1.03 to 0.10; 4 studies, 131 participants; low‐certainty evidence).

Authors' conclusions

Moderate‐certainty evidence showed that non‐surgical orthodontic treatments (which included facemask, reverse Twin Block, orthodontic removable traction appliance, chin cup, tandem traction bow appliance and mandibular headgear) improved the bite and jaw relationship immediately post‐treatment. Low‐certainty evidence showed surgical orthodontic treatments were also effective.

One study measured longer‐term outcomes and found that the benefit from facemask was reduced three years after treatment, and appeared to be lost by six years. However, participants receiving facemask treatment were judged by clinicians to be less likely to need jaw surgery in adulthood. We have low confidence in these findings and more studies are required to reach reliable conclusions.

Orthodontic treatment for Class III malocclusion can be invasive, expensive and time‐consuming, so future trials should include measurement of adverse effects and patient satisfaction, and should last long enough to evaluate whether orthodontic treatment in childhood avoids the need for jaw surgery in adulthood.

Keywords: Adolescent; Child; Child, Preschool; Humans; Dental Care; Malocclusion, Angle Class III; Malocclusion, Angle Class III/therapy; Mouth; Orthodontic Appliances; Orthodontics, Corrective

Plain language summary

Do braces correct or improve 'underbite' (prominent lower front teeth) in children and teens?

Key messages

Non‐surgical and surgical orthodontic treatments in childhood can improve the bite and jaw position. We do not know how long these effects last.

Future studies should be long enough to discover whether treating patients in childhood prevents the need for jaw surgery in adulthood.

What is 'underbite'?

Prominent lower front teeth ('underbite') can result from the upper jaw (maxilla) being too far back, lower jaw (mandible) too far forward, upper front teeth tipped back, lower front teeth tipped forward, or a combination. Underbite may result in teasing, eating difficulties and jaw joint problems.

How is it treated?

Orthodontic treatment for underbite involves braces fitted inside or outside the mouth and fixed to the teeth, or braces fitted around the head. The braces encourage the upper jaw and top teeth to move forwards and downwards, or restrict the growth of the bottom jaw, or both.

What did we want to find out?

This review, which updates the 2013 version, aimed to find out the effects of orthodontic treatment for underbite in children and adolescents.

What did we do?

We searched for studies that compared one type of brace for underbite to another type or no treatment. We summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We found 29 studies, involving 1169 children aged 5 to 13 years when treatment started. Most studies lasted between 5 and 18 months, and assessed outcomes at the end of treatment. Only one study assessed outcomes after the end of treatment. The studies used a wide variety of braces, including the following types.

Facemask: rests on the forehead and chin and is connected to the upper teeth by an expansion appliance – which widens the upper jaw to create more space or correct bite problems – with elastic bands placed by the wearer. The force causes the top teeth and jaw to move forward and downward.

Chin cup: rests on the chin with a strap around the back of the head to reduce forward growth of the lower jaw.

Orthodontic removable traction appliance (ORTA): expansion appliance is placed on the top teeth. Elastic bands, placed by the wearer, run from it to a clear, removable gumshield brace on the lower teeth. The force pulls the top teeth forwards and downwards and the bottom teeth back.

Reverse Twin Block with lip pads and expansion appliance: top and bottom removable braces with an expansion screw in the top brace, blocks of plastic over the side teeth, angled to hold the bottom jaw back, and plastic pads to hold the top lip away from the teeth.

Tandem traction bow appliance: attachments are fixed to top and bottom teeth. The top attachment has a hook on each side. A metal bar is placed in the lower attachment, which sits in front of the lower teeth. An elastic band is placed on each side to pull the top jaw forwards and bottom jaw backwards.

Surgical miniplates: metal plates, fixed to the bone with miniscrews, are placed under the gums during an operation. They have a visible hook from which elastic bands are placed by the wearer between the top and bottom jaws or to a facemask.

Main results

Combining studies, we found that non‐surgical orthodontic treatments and surgical orthodontic treatment with miniplates can substantially improve the bite and the jaw relationship, immediately after treatment.

Only one study, which assessed facemask, looked at long‐term effects of braces. Improvements in the bite and jaw position were seen after three years, but appeared to have been lost by six years. Nevertheless, orthodontists judged that children who had received facemask treatment were less likely to need jaw surgery in adulthood than those who did not have this treatment. More long‐term studies are needed to find out how long orthodontic treatment benefits last.

We combined results from studies that compared facemask treatment to other treatments. This did not show the other interventions to be superior to the facemask, but there was a lot of variation in the data, so we cannot draw reliable conclusions.

There may be no advantage to securing facemasks with surgical miniplates, but the evidence is uncertain and further research is needed.

Using a facemask without an expansion appliance may work as well as with an expansion appliance. Alternating between expansion and constriction may be no different than expansion alone. However, the evidence for facemask variations is uncertain. More research is needed to determine the optimal facemask therapy.

What are the limitations of the evidence?

The studies were small and everyone involved knew what orthodontic treatment the children were receiving. Our confidence in the evidence ranged from very low to moderate. We know that non‐surgical and surgical orthodontic treatments in childhood can treat underbite effectively, but how long this benefit lasts is uncertain. Whether one orthodontic treatment is more effective than another is also uncertain.

How up to date is this evidence?

The evidence is current to January 2023.

Summary of findings

Summary of findings 1. Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children.

Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children
Population: children with prominent lower front teeth Setting: dental hospitals Intervention: non‐surgical orthodontic treatment Comparison: no treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	No treatment	Non‐surgical orthodontic treatment
Overjet (greater is better) Follow‐up: at end of treatment (9 to 15 months)	Mean final overjet ranged from ‐0.33 to 0.3 mm	Mean overjet in intervention groups was 5.03 mm more (3.81 to 6.25 more)		184 (4 studies)	⊕⊕⊕⊝ Moderate^a	Long‐term outcome: one study testing facemask therapy evaluated overjet after 3 years (MD 2.5 mm, 95% CI 1.21 to 3.79; 63 participants; moderate‐certainty evidence^a), and 6 years (1.3 mm, ‐0.16 to 2.76; 65 participants; low‐certainty evidence^a,b).
ANB (greater is better) Follow‐up: at end of treatment (9 to 15 months)	Mean final ANB ranged from ‐1.5 to 0°	Mean ANB in intervention groups was 3.05° more (2.40 to 3.71 more)		345 (8 studies)	⊕⊕⊕⊝ Moderate^a	Long‐term outcome: one study testing facemask therapy evaluated ANB after 3 years (1.4°, 95% CI 0.43 to 2.37; 1 study, 63 participants; moderate‐certainty evidence^a), and 6 years (0.7°, 95% CI ‐74 to 2.14; 1 study, 65 participants; low‐certainty evidence^a,b).
Perceived need for surgery in adulthood Follow‐up: 6 years			OR 3.34 (95% CI 1.21 to 9.24)	65 (1 study)	⊕⊕⊝⊝ Low^a,b	This study evaluated the facemask.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ANB: A point, nasion, B point; CI: confidence interval; OR: odds ratio; RME: rapid maxillary expansion
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

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^aDowngraded due to high/unclear risk of bias ^bDowngraded due to imprecision of results

Summary of findings 2. Surgical orthodontic treatment versus no treatment for prominent lower front teeth in children.

Surgical orthodontic treatment versus no treatment for prominent lower front teeth in children
Population: children with prominent lower front teeth Setting: dental hospital Intervention: surgical orthodontic treatment Comparison: no treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	No treatment	Surgical orthodontic treatments
Overjet (greater is better) Follow‐up: at end of treatment	Mean final overjet ‐0.57 mm	Mean overjet in intervention group was 7.69 mm more (6.99 to 8.40 more)		30 (1)	⊕⊕⊝⊝ Low^a,b
ANB (greater is better) Follow‐up: at end of treatment	Mean final ANB 0.82°	Mean ANB in intervention group was 5.20° more (4.48 to 5.92 more)		30 (1)	⊕⊕⊝⊝ Low^a,b
Perceived need for surgery in adulthood	Not measured
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ANB: A point, nasion, B point; CI: confidence interval
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

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^aDowngraded due to risk of bias: due to the nature of the interventions, participants could not be blinded ^bDowngraded due to uncertainty in the evidence because it is a single trial

Summary of findings 3. Facemask therapy versus other non‐surgical orthodontic treatment for prominent lower front teeth in children.

Facemask therapy versus other non‐surgical orthodontic treatments for prominent lower front teeth in children
Population: children with prominent lower front teeth Setting: dental hospital Intervention: facemask (RME) or modified facemask Comparison: other orthodontic treatments
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Other non‐surgical treatment	Facemask (RME) or modified facemask
Overjet (greater is better) Follow‐up: at end of treatment	Mean final overjet ranged from 1.25 to 5.45 mm	Mean final overjet was 0.96 mm more (0.12 less to 2.04 mm more)		136 (4 studies)	⊕⊝⊝⊝ Very low^a‐c	The high heterogeneity in the results, with findings in different directions, means the evidence is very uncertain. Only one small study was available for each subgroup.
ANB (greater is better) Follow‐up: at end of treatment	Mean final ANB ranged from 1.4 to 4.63°	Mean final ANB was 0.11° more (0.54 less to 0.77° more)		285 (8 studies)	⊕⊝⊝⊝ Very low^a‐c
Perceived need for surgery in adulthood	Not measured
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ANB: A point, nasion, B point; CI: confidence interval; RME: rapid maxillary expansion
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

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^aDowngraded due to risk of bias: blinding and/or selective reporting i.e. did not report on overjet and/or high attrition ^bDowngraded due to imprecision of the results ^cDowngraded due to inconsistency of the results amongst the studies (high heterogeneity)

Summary of findings 4. Facemask therapy versus surgical orthodontic treatment for prominent lower front teeth in children.

Facemask therapy versus surgical orthodontic treatment for prominent lower front teeth in children
Population: children with prominent lower front teeth Settings: dental hospital Intervention: facemask (RME) or modified facemask Comparison: surgical orthodontic treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Surgical orthodontic treatment	Facemask (RME) or modified facemask
Overjet (greater is better) Follow‐up: at end of treatment	Mean final overjet was 6.19 mm	Mean final overjet was 0.40 mm less (1.30 mm less to 0.50 mm more)		43 (1 study)	⊕⊝⊝⊝ Very low^a‐c
ANB (greater is better) Follow‐up: at end of treatment	Mean final ANB ranged from 1.4 to 4.37°	Mean final ANB was 0.35° less (0.78° less to 0.07° more)		143 (4 studies)	⊕⊕⊝⊝ Low^a,b
Perceived need for surgery in adulthood	Not measured
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ANB: A point, nasion, B point; CI: confidence interval; RME: rapid maxillary expansion
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

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^aDowngraded due to risk of bias: blinding and/or selective reporting, i.e. did not report on overjet and/or high attrition ^bDowngraded due to imprecision of the results ^cDowngraded due to uncertainty in the evidence because it is a single trial

Summary of findings 5. Facemask variations for prominent lower front teeth in children.

Facemask variations for prominent lower front teeth in children
Population: children with prominent lower front teeth Setting: dental hospital Intervention: facemask A Comparison: facemask B
Outcomes	Illustrative comparative risks*		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Assumed risk	Corresponding risk	Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
Facemask only versus facemask (RME)
	Facemask (RME)	Facemask only
Overjet (greater is better) Follow‐up: at end of treatment	Mean final overjet was 4.51 mm	Mean final overjet was 1.86 mm more (95% CI 0.39 to 3.33)	‐	31 (1 study)	Low^a,b ⊕⊕⊝⊝
ANB (greater is better) Follow‐up: at end of treatment	Mean final ANB ranged from 3.27 to 3.82°	Mean final ANB was 0.15° lower (95% CI 0.94° lower to 0.64° higher)	‐	60 (2 studies)	Low^a,c ⊕⊕⊝⊝
Facemask (Alt‐RAMEC) versus facemask (RME)
	Facemask (RME)	Facemask (Alt‐RAMEC)
Overjet	Not measured
ANB (greater is better) Follow‐up: at end of treatment	Mean final ANB ranged from 3.45 to 4.35°	Mean ANB was 0.46° lower (1.03° lower to 0.10° higher)	‐	131 (4 studies)	Low^a,c ⊕⊕⊝⊝
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Alt‐RAMEC: alternating rapid maxillary expansion and constriction; ANB: A point, nasion, B point; CI: confidence interval; RME: rapid maxillary expansion
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

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^aDowngraded due to risk of bias: blinding ^bDowngraded due to uncertainty in the evidence because it is a single trial ^cDowngraded due to imprecision of the results

Background

Description of the condition

Orthodontics is the branch of dentistry concerned with the growth of the jaws and face, the development of the teeth, and the way the teeth and jaws bite together. It also involves treatment of the teeth and jaws when they are irregular or bite in an abnormal way, or both. There are many reasons why the teeth may not bite together correctly. These include the position of the teeth, jaws, lips, tongue and/or cheeks, or may be due to a habit or the way people breathe. All of these factors can be influenced by genetics or the environment. The need for treatment can be decided by looking at the effect of any particular tooth position on the life expectancy or function of the teeth or the effect that the appearance of the teeth has on how people feel about themselves, or a combination (Shaw 1991).

Prominent lower front teeth (also termed reverse bite, underbite, Class III malocclusion, anterior crossbite) may be due to a combination of the jaw and/or tooth position, resulting from genetic factors, environmental influence or both. The upper jaw (maxilla) can be too far back, the lower jaw (mandible) too far forward, or both. Prominent lower front teeth can also occur if the upper front teeth (incisors) are tipped back, the lower front teeth are tipped forwards, or both.

Prominent lower front teeth can give a person an aggressive appearance, which may be the source of teasing (Shaw 1980). People with prominent lower front teeth often report that they have problems eating and occasionally problems with speech. Prominent lower front teeth can give rise to problems with the jaw joints in later life (Mohlin 1980). Prominent lower front teeth are most common in people of East Asian ethnicity (11%) and are relatively uncommon in people of African (3.5%) and European (4%) ethnicity (Alhammadi 2018; El‐Mangoury 1990; Proffit 1993; Silva 2001).

Description of the intervention

Orthodontic (dental brace) treatments to correct prominent lower front teeth (Class III malocclusion) aim to tip the top front teeth forwards and the bottom front teeth backwards, or modify the growth of the upper or lower jaw, or both. Treatment can involve the use of one or more types of orthodontic brace. Some braces apply a force directly to the teeth and can either be removed from the mouth or fixed to the teeth with special glue. Other types of brace are attached, via the teeth, to devices (for example, facemask, chin cup, reverse headgear) that allow a force to be applied to the teeth and jaws from the chin or forehead, or both.

Newer interventions used to correct prominent lower front teeth that involve surgery include metal miniplates and miniscrews (De Clerck 2010; Jamilian 2011a), which are placed into the jaw bones. These act as an anchor from which elastic forces can be applied to the teeth and jaws or appliances secured.

In severe cases, orthodontic treatment may need to be combined with orthognathic (jaw) surgery, in adulthood, to correct the position of one or both jaws.

Treatment for Class III malocclusion is usually carried out either 'early', when individuals have a mixture of their baby and adult teeth present (around seven to 11 years of age), or 'late' when all the adult teeth have come into the mouth (around 12 to 16 years of age). However, treatment can also be carried out very early, before six years of age, when children have only their baby teeth, or much later, in adulthood, when jaw surgery is required.

How the intervention might work

There are several ways in which the intervention may correct the prominence of the lower front teeth. It may move the upper jaw forwards, the top teeth forwards, the lower jaw backwards, the bottom teeth backwards, or often a combination of these movements. Some interventions may also have an influence on the vertical position of the jaws, which in turn influences the anteroposterior position of the jaws due to the rotation of the jaws during growth.

There are various ways to measure tooth movement, and considerable effort is being made within the orthodontic profession to establish core outcome sets for orthodontic research (Tsichlaki 2020). However, currently, there is no consensus about these outcome sets or about the minimal clinically important differences for key outcomes.

Why it is important to do this review

There are many different appliances available to try to correct the prominence of lower front teeth in children. There is, however, little agreement as to which of these approaches may be best. Also, little is known about the long‐term effects of these approaches. If a successful approach could be found, one that has effects that last until the end of growth, this may prevent the need for jaw surgery when the patient is older.

Many new studies have been published since the first version of this review (Watkinson 2013). This update synthesises and analyses the currently available evidence on orthodontic treatment for Class III malocclusion in children, and will be of use to patients, parents and healthcare professionals.

Objectives

To assess the effects of orthodontic treatment for prominent lower front teeth in children and adolescents.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) of orthodontic treatments to correct prominent lower front teeth in children and adolescents.

Types of participants

Children and adolescents (aged 16 years or younger) receiving orthodontic treatment to correct prominent lower front teeth (Class III malocclusion).

We excluded studies in children with a cleft lip or palate or both, or other craniofacial deformities or syndromes. In studies with participants aged above and below our upper age limit of 16 years, we only included studies if at least 80% of the participants were children or adolescents. We excluded studies in children who had previously received surgical treatment for their prominent lower front teeth.

Types of interventions

Active intervention

Non‐surgical orthodontic interventions (which can be removable, fixed and/or functional), including but not limited to: facemask, chin cup, mandibular headgear, reverse Twin Block
Surgically‐anchored orthodontic interventions, including but not limited to: miniscrews, miniplates, bone‐anchored intermaxillary traction
Any other intra‐ or extra‐oral intervention aimed at correcting prominent lower front teeth

Control

No treatment
Delayed treatment
Another active intervention

Types of outcome measures

We recorded clinically important outcomes at the most commonly reported time points. When we identified harms, we recorded and reported them in descriptive terms.

Primary outcomes

Prominence of the lower front teeth (overjet, measured in mm or by any index of malocclusion)

Secondary outcomes

Relationship between the upper and lower jaw, as measured by the ANB (A point, nasion, B point) angle or the Wits appraisal, both of which measure the relative position of the maxilla to the mandible
Psychosocial measures
Patient satisfaction
Surgery in adulthood
Adverse effects, including but not limited to jaw joint problems, health of the gums (gingivae), damage to the teeth (e.g. tooth decay)

Search methods for identification of studies

Electronic searches

Cochrane Oral Health’s Information Specialist conducted systematic searches in the following databases for randomised controlled trials and controlled clinical trials. There were no language, publication year or publication status restrictions.

Cochrane Oral Health’s Trials Register (searched 16 January 2023) (Appendix 1)
Cochrane Central Register of Controlled Trials (CENTRAL; 2022, Issue 12) in the Cochrane Library (searched 16 January 2023) (Appendix 2)
MEDLINE Ovid (1946 to 16 January 2023) (Appendix 3)
Embase Ovid (1980 to 16 January 2023) (Appendix 4)

Subject strategies were modelled on the search strategy designed for MEDLINE Ovid. Where appropriate, they were combined with subject strategy adaptations of the highly sensitive search strategies designed by Cochrane for identifying randomised controlled trials and controlled clinical trials (as described in the Cochrane Handbook for Systematic Reviews of Interventions, version 6.3 (Lefebvre 2022)).

Searching other resources

Cochrane Oral Health’s Information Specialist searched the following trial registries for ongoing studies:

US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov; searched 16 January 2023) (Appendix 5);
World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch; searched 16 January 2023) (Appendix 6).

We searched the reference lists of included studies and relevant systematic reviews, for further studies or articles related to identified studies.

We did not perform a separate search for adverse effects of interventions used; we considered adverse effects described in the included studies only.

Data collection and analysis

Selection of studies

The search was designed to be sensitive and included controlled clinical trials; these were filtered out early in the selection process if they were not randomised.

In 2013, two review authors (either Simon Watkinson (SW) and Jayne Harrison (JH) or Sue Furness (SF)), independently and in duplicate, screened the titles and abstracts of the search results to remove obviously irrelevant reports. We resolved disagreements by discussion; if arbitration was required, it was provided by Annabel Teague (AT).

For the 2024 update, three of the review authors (Darren Owens (DO), Sarah Turner (ST) and JH), independently and in triplicate, screened titles and abstracts identified by the updated searches. We resolved disagreements by discussion; if arbitration was required, it was provided by SW.

Two review authors (SW and JH or SF (2013); DO and ST or JH (2024)), independently and in duplicate, examined full‐text reports of potentially eligible studies for compliance with the eligibility criteria. We corresponded with investigators to clarify study eligibility when required. We resolved disagreements by discussion; if arbitration was required, it was provided by AT (2013) and JH or SW (2024).

If additional information was required, we contacted the corresponding author of the study and classed the study as 'awaiting assessment'.

We recorded study eligibility using a piloted study eligibility form (2013), which we converted to Microsoft Excel (Microsoft Corporation, USA) for the 2024 update.

We listed each excluded study, along with the primary reason for exclusion.

Data extraction and management

Two review authors (SW and JH or SF (2013)); DO and ST or JH (2024)), independently and in duplicate, performed data extraction. We used a piloted data extraction form to record key information, including the year of publication, sample size, participant age, interventions assessed, outcomes including adverse effects, and time points of outcome assessment (immediately after treatment or at longer follow‐up). For the 2024 update, we converted the data extraction form to Microsoft Excel (Microsoft Corporation, USA).

Assessment of risk of bias in included studies

We used the Cochrane risk of bias (RoB 1) tool to assess the risk of bias in the studies(Higgins 2011). Two review authors (SW and JH or SF (2013); DO and ST or JH (2024)), independently and in duplicate, investigated seven domains: sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessors; incomplete outcome data; selective outcome reporting; and 'other potential sources of bias'. For each domain, we recorded what was reported to have happened and then made a judgement as to the risk of bias for that entry, either 'low risk', 'high risk' or, where there was insufficient information on which to base a judgement, 'unclear risk'.

After taking into account the additional information provided by the authors of the trials, we judged the overall risk of bias for each study according to the following criteria. Because of the inevitability of a risk of performance bias, we did not consider this a 'key domain'.

Low risk of bias (plausible bias unlikely to seriously alter the results) if we assessed all key domains as at low risk of bias.
Unclear risk of bias (plausible bias that raises some doubt about the results) if we assessed one or more key domains as unclear.
High risk of bias (plausible bias that seriously weakens confidence in the results) if we assessed one or more key domains as at high risk of bias.

Measures of treatment effect

We followed Cochrane statistical guidelines, analysed data using Review Manager (RevMan) 5 software (RevMan 2012) or RevMan Web (RevMan Web 2023), and reported findings according to Cochrane criteria.

For dichotomous data, we expressed the estimates of the effect of an intervention as risk ratios (RR) together with 95% confidence intervals (CI).

For continuous outcomes, we used mean differences (MD) and 95% CIs to summarise the data for each group where the MD and standard deviations were calculable from the data presented.

Unit of analysis issues

The unit of analysis was the participant. Where we included a study with more than one relevant intervention arm in a meta‐analysis, we divided the control group in half, in order to avoid double‐counting participants.

Dealing with missing data

If there were any missing data, we attempted to contact the original study investigators. We did not exclude studies from the review because of missing summary data; however, the potential implications of their absence from any meta‐analysis were discussed.

Assessment of heterogeneity

We assessed clinical heterogeneity by examining the types of participants, interventions and outcomes in each study. We used meta‐analysis only when studies of similar comparisons reported comparable outcome measures. We used the I² statistic as a measure of statistical heterogeneity.

Assessment of reporting biases

Only a proportion of all research studies conducted are ultimately published in an indexed journal and therefore easily identifiable for inclusion in systematic reviews. Reporting biases arise when the reporting of research findings is influenced by the nature and direction of the findings of the research (Easterbrook 1991). We investigated and attempted to minimise potential reporting biases including publication bias, multiple (duplicate) publication bias and language bias in this review.

Had there been more than 10 studies for one outcome, we would have constructed a funnel plot. If there had been asymmetry in the funnel plot, indicating possible publication bias, we would have undertaken statistical analysis using the methods introduced by Egger 1997 (for continuous outcomes) and Rücker 2008 (for dichotomous outcomes).

Data synthesis

We performed meta‐analysis only if there were studies with similar comparisons that reported the same outcome measures. For analyses of primary and secondary outcomes with four or more studies, we used random‐effects meta‐analyses, with the inverse‐variance method; for combining two or three studies, we used the fixed‐effect model. We reported adverse effects (harms) descriptively.

Subgroup analysis and investigation of heterogeneity

As described above, we investigated clinical heterogeneity by examining: the nature of the interventions; ages, background and number of participants; and reported outcomes. No subgroup analyses were planned.

Sensitivity analysis

Had there been sufficient studies for each intervention and outcome, we would have undertaken sensitivity analysis based on our risk of bias judgements.

Summary of findings and assessment of the certainty of the evidence

We produced summary of findings tables for key outcomes of this review (overjet, ANB and need for jaw surgery in adulthood) for five comparisons:

orthodontic non‐surgical interventions versus untreated control;
surgical orthodontic interventions versus untreated control;
facemask versus other non‐surgical orthodontic treatments;
facemask versus surgically‐anchored appliances; and
facemask variations.

We assessed the certainty of the body of evidence for these comparisons and outcomes, using GRADE criteria, as high, moderate, low or very low (Schünemann 2013). We considered the overall risk of bias in the included studies, directness of the evidence, consistency of the results, precision of the estimates and risk of publication bias (Schünemann 2013). We presented our judgements in the summary of findings tables and alongside the relevant result in the Effects of interventions section below.

Results

Description of studies

Results of the search

We identified 1305 records from our database searches and 23 from other sources; of these, 359 were duplicates. Of the 969 unique records, we discarded 862 during the screening of the titles and abstracts. We examined the full texts of the remaining 107 articles and excluded 56 articles (corresponding to 54 studies), with reasons for exclusion (see Characteristics of excluded studies), leaving 51 articles. Thirteen of these articles are related to 13 ongoing studies (see Characteristics of ongoing studies). We listed one study (reported in two articles) as 'awaiting classification' (see Characteristics of studies awaiting classification), and we included 29 studies (reported in 36 articles/trial register records) in this review update. We present a diagram of the study selection process in Figure 1.

Included studies

We included 29 studies, involving 1169 participants, in this review. All studies were parallel‐group RCTs. Six of the studies were three‐arm trials (Abdelnaby 2010; Arun 1994; Elnagar 2016; Minase 2019; Vaughn 2005; Yavan 2023). Most studies measured outcomes at the beginning and end of treatment, with the range of average treatment time being between four and 13 months, though some studies did not state how long treatment lasted. Only one study provided long‐term follow‐up (Mandall 2010).

Characteristics of the study setting and investigators

Nine studies were conducted in China (Chen 2012; Ge 2012; Liang 2021; Liu 2013; Liu 2015; Ma 2009; Xu 2001; Yao 2015; Zhang 2018), six in Turkey (Arun 1994; Atalay 2010; Canturk 2015; Celikoglu 2015; Keles 2002; Yavan 2023), three in Iran (Jamilian 2011; Showkatbakhsh 2012; Showkatbakhsh 2013), three in Syria (Husson 2016; Majanni 2016; Alzabibi 2021), and one each in Brazil (Miranda 2021), Egypt (Abdelnaby 2010), Italy (Galeotti 2021), India (Minase 2019), Japan (Seiryu 2020), the United Kingdom (Mandall 2010), and the USA (Vaughn 2005). One study was conducted in two centres: in Egypt and the USA (Elnagar 2016).

All but two of the included studies were conducted in college or university orthodontic departments. Twenty‐six of the studies were carried out in a single academic institution (Abdelnaby 2010; Alzabibi 2021; Arun 1994; Atalay 2010; Canturk 2015; Celikoglu 2015; Chen 2012; Husson 2016; Galeotti 2021; Ge 2012; Keles 2002; Liang 2021; Liu 2013; Liu 2015; Ma 2009; Majanni 2016; Minase 2019; Miranda 2021; Seiryu 2020; Showkatbakhsh 2012; Showkatbakhsh 2013; Vaughn 2005; Xu 2001; Yao 2015; Yavan 2023; Zhang 2018), and one in the orthodontic departments of two universities in Egypt and the USA (Elnagar 2016). One study was conducted in eight hospital departments in the same country (Mandall 2010). One study was carried out in a private orthodontic practice (Jamilian 2011).

Orthodontists provided the care for the children in all the studies. Four studies reported they had two operators (Celikoglu 2015; Husson 2016; Liang 2021; Vaughn 2005), seven studies reported a single operator (Alzabibi 2021; Canturk 2015; Elnagar 2016; Miranda 2021; Showkatbakhsh 2012; Showkatbakhsh 2013; Yavan 2023), and the remainder either did not disclose the number of operators or it was unclear how many were involved.

Only one study disclosed external funding (Mandall 2010). Five studies disclosed internal funding from their respective university research funds (Liang 2021; Liu 2015; Majanni 2016; Miranda 2021; Yao 2015). Four studies reported that they had no extra funding source (Husson 2016; Miranda 2021; Seiryu 2020; Yavan 2023). The remaining 19 studies did not disclose a funding source.

Characteristics of the participants

All studies involved children aged between five and 13 years at the start of treatment. They were from different ethnic backgrounds, depending on the location of the study, and most of the studies did not explicitly state the ethnicity of their participants. There were between 20 (Jamilian 2011; Keles 2002) and 73 children (Mandall 2010) included in each study, with an average of 38. Approximately equal numbers of boys and girls were included in each study.

Characteristics of the interventions

Numerous interventions (and variations of them) were identified in the 29 included studies.

Non‐surgical orthodontic treatments

Facemask therapy

Five studies compared the facemask to no or delayed treatment (Mandall 2010; Minase 2019; Vaughn 2005; Xu 2001; Yavan 2023).

Eight studies compared variations of the facemask:

Facemask with expansion (rapid maxillary expander (RME)) versus facemask only (Ma 2009; Vaughn 2005)
Facemask (RME) versus facemask alternating expansion and constriction (Alt‐RAMEC) (Chen 2012; Liu 2013; Liu 2015; Yao 2015)
Facemask after alternating rapid maxillary expansion and constriction versus facemask started simultaneously with alternating rapid maxillary expansion and constriction (Canturk 2015)
Facemask (Nanda) versus facemask (RME) (Keles 2002)

Eight studies compared the facemask to other non‐surgical orthodontic treatments:

Facemask (RME) versus mini maxillary protractor (Celikoglu 2015)
Pushing Splints versus facemask (RME) (Galeotti 2021)
Modified Tandem Appliance versus facemask (RME) (Husson 2016)
Facemask (RME) versus Reverse Forsus (Yavan 2023)
Reverse Twin Block with lip pads and rapid maxillary expander versus facemask (RME) (Minase 2019)
Facemask versus reverse chin cup (Showkatbakhsh 2012)
Facemask versus tongue plate appliance (Showkatbakhsh 2013)
Facemask with frame internal fixation versus Frankel III functional appliance (Zhang 2018)

Four studies compared the facemask to surgically‐anchored appliances:

Facemask with miniscrew implant versus RME with facemask (Ge 2012)
Facemask and upper removable appliance (URA) versus URA with miniscrew and Class III traction (Jamilian 2011)
Surgical miniplates (facemask) versus facemask (RME) (Liang 2021)
Facemask with transpalatal arch versus facemask with transpalatal arch and miniscrew (Seiryu 2020)

Other non‐surgical interventions

Six studies compared other non‐surgical orthodontic appliances to no treatment, with two of the studies also including a head‐to‐head comparison:

Chin cup versus untreated control (Abdelnaby 2010; Arun 1994)
Tandem traction bow appliance versus untreated control (Atalay 2010)
Reverse Twin Block with lip pads (RME) versus untreated control (Minase 2019)
Reverse Forsus versus untreated control (Yavan 2023)
Orthodontic removable traction appliance (ORTA) versus untreated control (Alzabibi 2021)
Mandibular headgear versus untreated control (Arun 1994)
600 g chin cup versus 300 g chin cup (Abdelnaby 2010)
Mandibular headgear versus chin cup (Arun 1994)

Surgically‐anchored appliances

Two studies compared one surgically‐anchored appliance to another, with one of the studies also including a no‐treatment control group. A further study compared a surgically‐anchored appliance to a removable appliance.

Surgical miniplates (with facemask) versus untreated control (Elnagar 2016)
Surgical miniplates (with class III elastics) versus untreated control (Elnagar 2016)
Surgical miniplates with facemask (RME) versus surgical miniplates with Class III elastics (Elnagar 2016)
Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics (Miranda 2021)
Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (Majanni 2016)

Comparisons

An orthodontic intervention was compared to an untreated control group in 10 of the 29 included studies (nine non‐surgical interventions and one surgical intervention). Ten studies compared one orthodontic intervention to a different type of orthodontic intervention. Eleven studies compared two variations of the same treatment.

As noted in Summary of findings and assessment of the certainty of the evidence, we have presented the findings of five comparisons in our summary of findings tables:

non‐surgical orthodontic interventions versus untreated control (Table 1);
surgical orthodontic interventions versus untreated control (Table 2);
facemask versus other non‐surgical orthodontic treatments (Table 3);
facemask versus surgically‐anchored appliances (Table 4); and
facemask variations (Table 5).

Characteristics of the outcomes

The included studies reported the outcomes listed below. Most studies reported outcome data immediately post‐treatment or up to 15 months after the start of treatment. One study reported longer‐term outcomes, at three and six years after the start of treatment (Mandall 2010).

Primary outcome

Prominence of lower front teeth

Overjet (13 studies): Alzabibi 2021; Atalay 2010; Canturk 2015; Celikoglu 2015; Elnagar 2016; Galeotti 2020; Ge 2012; Husson 2016; Ma 2009; Majanni 2016; Mandall 2010; Miranda 2021; Yavan 2023

Secondary outcomes

Relationship between the upper and lower jaw

ANB (28 studies): Abdelnaby 2010; Alzabibi 2021; Arun 1994; Atalay 2010; Canturk 2015; Celikoglu 2015; Chen 2012; Elnagar 2016; Ge 2012; Husson 2016; Jamilian 2011; Keles 2002; Liang 2021; Liu 2013; Liu 2015; Ma 2009; Majanni 2016; Mandall 2010; Minase 2019; Miranda 2021; Seiryu 2020; Showkatbakhsh 2012; Showkatbakhsh 2013; Vaughn 2005; Yao 2015; Yavan 2023; Xu 2001; Zhang 2018
Wits appraisal (13 studies): Abdelnaby 2010; Alzabibi 2021; Canturk 2015; Chen 2012; Galeotti 2020; Ge 2012; Liu 2013; Liu 2015; Ma 2009; Minase 2019; Miranda 2021; Vaughn 2005; Zhang 2018
A‐Nasion perpendicular: Yao 2015
AN‐Pogonion: Galeotti 2020

Psychosocial measures

Piers‐Harris children's self‐concept scale (Mandall 2010)
Oral Aesthetic Subjective Impact Score (OASIS) (Mandall 2010)

Patient satisfaction

Acceptance of appliances (Majanni 2016)

Surgery in adulthood

Perceived need for orthognathic surgery (Mandall 2010)

Adverse effects

Pain or discomfort (Majanni 2016)
Temporomandibular joint signs and symptoms (Mandall 2010)
Breakages, oral hygiene difficulty, skin irritation (Galeotti 2021)
Serious harm (Seiryu 2020)

Excluded studies

The main reason for the exclusion of each of the 54 excluded studies is listed below and presented in the Characteristics of excluded studies.

Twenty‐four were not RCTs (Akhoundi 2009; Biren 1993; Bozkaya 2017; Celikoglu 2017; Cha 2011; Cozza 2004; Gokalp 2010; Goyenc 2004; Hino 2014; Ierardo 2018; Isci 2010; Kurt 2011; Lee 2012; Loca‐Apichai 2022; Lucchi 2022; Mucedero 2007; Pavoni 2009; Pilehvar 2021; Sar 2011; Solano‐Mendoza 2012; Ucem 2004; Ulgen 1994; Yagci 2010; Zaidao 2017).
Ten were retrospective (Bavbek 2014; Erdur 2020; Franchi 2014; Halicioglu 2014; He 2013; Kaygisiz 2022; Lee 2019; Sar 2014; Tortop 2014; Yagci 2011).
Six used retrospective control groups (Altug 1989; Arman 2004; Arman 2006; Baik 1995; Barrett 2010; Tortop 2007).
Five did not report an outcome of interest for this review (Celebi 2020; El 2010; Saleh 2013; Wang 2018; Zhang 2008).
Two looked at interventions that were not treatments for Class III malocclusion (Miamoto 2017; Wiedel 2014).
One reported outcomes for participants over the age of 16 years (Wilmes 2009).
One postponed the treatment in the control group (Zhao 2015).
One used a matched control group (Celikoglu 2014).
One used a control group that refused or discontinued treatment (Chen 2011).
One was a review article (Zere 2018).
One was an overview of reviews (Papageorgiou 2016).
For one, we had doubts about its method of allocation, and received no response from the study author to our query about this (Kilicoglu 1998).

See Characteristics of excluded studies tables for further details.

Risk of bias in included studies

Due to the nature of the interventions, it was not possible to blind participants or personnel, which means all studies were considered at high risk of bias for blinding. However, when this domain was omitted, seven studies were at overall low risk of bias (Alzabibi 2021; Elnagar 2016; Galeotti 2021; Jamilian 2011; Majanni 2016; Mandall 2010; Yavan 2023). Ten studies were at high risk of bias overall (Arun 1994; Atalay 2010; Ge 2012; Liang 2021; Liu 2013; Liu 2015; Ma 2009; Miranda 2021; Seiryu 2020; Showkatbakhsh 2013), and for the remaining 12 studies, we assessed the risk of bias as unclear (Abdelnaby 2010; Canturk 2015; Celikoglu 2015; Chen 2012; Husson 2016; Keles 2002; Minase 2019; Showkatbakhsh 2012; Vaughn 2005; Xu 2001; Yao 2015; Zhang 2018). More detail on the individual domains is reported below and depicted in Figure 2 and Figure 3.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Allocation

Sequence generation

Sequence generation was adequate for 23 of the studies (Alzabibi 2021; Arun 1994; Atalay 2010; Canturk 2015; Celikoglu 2015; Elnagar 2016; Galeotti 2021; Husson 2016; Jamilian 2011; Liu 2013; Liu 2015; Ma 2009; Majanni 2016; Mandall 2010; Minase 2019; Miranda 2021; Seiryu 2020; Showkatbakhsh 2012; Showkatbakhsh 2013; Vaughn 2005; Yao 2015; Yavan 2023; Zhang 2018). Whilst the Arun 1994 and Atalay 2010 papers were unclear, contact with the authors revealed the use of a random number generator for participant assignment on registration in the study. Canturk 2015 and Jamilian 2011 used pitch‐and‐toss to randomise participants to orthodontic treatments. Liu 2015 used block randomisation with a block length of six. Mandall 2010 and Galeotti 2021 used randomisation blocks of 10, with stratification according to sex, and a computer‐generated randomisation sequence. Vaughn 2005 also used a block randomisation table to assign participants to one of the three groups. Alzabibi 2021, Elnagar 2016 and Showkatbakhsh 2012 used a computer‐generated random number table, with Celikoglu 2015, Liu 2013, Ma 2009, Showkatbakhsh 2013, Yao 2015 and Zhang 2018 reporting use of a random number table. Majanni 2016, Minase 2019, Seiryu 2020 and Yavan 2023 all described simple randomisation with the use of computer software. Husson 2016 and Miranda 2021 described the use of an online randomisation service.

The remaining six studies had unclear risk of bias for random sequence generation. Chen 2012 was translated from Chinese and there was no description of the method of randomisation. In Abdelnaby 2010, participants were "randomly divided into three groups"; however, groups 1 and 2 have double the number of participants compared to group 3. Ge 2012, Keles 2002 and Xu 2001 did not describe how the random sequence was generated, and we did not receive a response from the study authors to our request for further clarification. The exact randomisation method used in Liang 2021 remained unclear even after communication with the authors.

Allocation concealment

Allocation concealment was adequate in 10 of the included studies (Alzabibi 2021; Elnagar 2016; Galeotti 2021; Jamilian 2011; Majanni 2016; Mandall 2010; Miranda 2021; Seiryu 2020; Showkatbakhsh 2012; Yavan 2023). Whilst Elnagar 2016 was unclear in the text, contact with the authors revealed the use of sealed opaque envelopes that were shuffled by a staff member. Alzabibi 2021 and Yavan 2023 reported the use of sealed opaque envelopes provided by another researcher but did not mention whether they were sequentially numbered. Majanni 2016, Miranda 2021 and Seiryu 2020 reported the use of sequentially numbered, opaque and sealed envelopes. Mandall 2010 used a sequence that was concealed centrally, and each clinician telephoned the research assistant for allocation once the participant was registered. The author of Jamilian 2011 confirmed that the coin was flipped after the participants were recruited. Showkatbakhsh 2012 concealed the allocation from the clinician until the time of appliance fitting.

The method of allocation concealment was unclear for 16 studies as there was no mention of allocation concealment in the articles, and there was either no response from study authors to our requests for clarification or it was not possible to contact them to provide clarification (Abdelnaby 2010; Canturk 2015; Celikoglu 2015; Chen 2012; Ge 2012; Husson 2016; Keles 2002; Liu 2013; Liu 2015; Ma 2009; Minase 2019; Showkatbakhsh 2013; Vaughn 2005; Xu 2001; Yao 2015; Zhang 2018).

We judged there to be a high risk of bias in Arun 1994 and Atalay 2010 as it was disclosed by email that no allocation concealment was used. This was also the case for Liang 2021, although there may have been confusion between allocation concealment and blinding.

Blinding

Performance bias

The blinding of participants was not possible due to the nature of the treatments being compared or the controls being observed or untreated. For this reason, we assessed all studies at high risk of bias for blinding of participants and personnel.

Ten studies reported that treatment was carried out by the same clinician or clinicians (Alzabibi 2021; Canturk 2015; Celikoglu 2015; Elnagar 2016; Jamilian 2011; Liang 2021; Miranda 2021; Showkatbakhsh 2012; Showkatbakhsh 2013; Yavan 2023). It was unclear how many clinicians provided the treatment in the other studies. This may reduce the generalisability of the studies.

Detection bias

Blinding of the outcome assessment would have been possible in all studies where cephalometric measures were used as outcomes. Although not clear from the papers, we assessed four studies as being suitably blinded after clarification was received from the authors (Elnagar 2016; Jamilian 2011; Majanni 2016; Minase 2019). There was a low risk of bias in the Alzabibi 2021, Galeotti 2021, Husson 2016, Mandall 2010, Miranda 2021, Showkatbakhsh 2013 and Yavan 2023 studies as the researchers who were measuring the radiographs and/or study models were blinded. There was also low risk of bias in the Vaughn 2005 study as the principal investigator carrying out the analysis was blinded to participant assignment.

The blinding of outcome assessment was unclear in the Abdelnaby 2010, Canturk 2015, Celikoglu 2015, Chen 2012, Ge 2012, Keles 2002, Liang 2021, Xu 2001, Yao 2015 and Zhang 2018 studies as there was no mention of blinding in the papers and our query about this received no response or an inconclusive response from the authors. Showkatbakhsh 2012 mentions that it was not possible to blind the clinicians but does not mention whether the individual undertaking cephalometric analysis was blinded.

We judged the Arun 1994 and Atalay 2010 studies to be at high risk of bias as their authors confirmed that there were no attempts at blinding at any stage. After clarification, the authors of Seiryu 2020 reported that the miniscrews were not removed prior to the final radiograph exposures, and therefore we judged this study to be at high risk of bias. Liu 2013, Liu 2015 and Ma 2009 reported that there was no blinding of the assessor and therefore were also judged to be at high risk of bias.

Incomplete outcome data

We judged 21 studies to be at low risk of attrition bias as all participants entering the studies were accounted for and any loss to follow‐up was small (Alzabibi 2021; Arun 1994; Atalay 2010; Canturk 2015; Celikoglu 2015; Galeotti 2021; Husson 2016; Jamilian 2011; Liang 2021; Liu 2013; Liu 2015; Ma 2009; Majanni 2016; Mandall 2010; Minase 2019; Seiryu 2020; Showkatbakhsh 2012; Showkatbakhsh 2013; Xu 2001; Yavan 2023; Zhang 2018). Although not clear in the paper, the authors of Elnagar 2016 confirmed that there were no dropouts during the study.

The risk of attrition bias was unclear in five studies as the number of dropouts was unclear, and the authors did not respond to our requests to clarify the risk of attrition bias (Abdelnaby 2010; Chen 2012; Keles 2002; Vaughn 2005; Yao 2015).

We judged two studies to be at high risk of attrition bias: the number lost to follow‐up in one of the groups (miniscrew implant with facemask) in the Ge 2012 study was 20% of the starting sample, and in Miranda 2021, the last five participants in one of the groups (CH) were not treated because of adverse collateral effects occurring during treatment therapy in two of 15 participants, giving a 25% dropout rate.

Selective reporting

We judged all studies to be at low risk of reporting bias as all studies reported the outcomes that they set out to report. However, 10 studies did not set out to report on overjet, which is surprising (Abdelnaby 2010; Arun 1994; Jamilian 2011; Keles 2002; Liang 2021; Showkatbakhsh 2012; Showkatbakhsh 2013; Vaughn 2005; Xu 2001; Yao 2015). Overjet is the primary outcome of this review and is highly relevant to the correction of Class III malocclusion.

Other potential sources of bias

We judged all studies to be at low risk of other potential biases. Mandall 2010 disclosed that some participants in the study had a centric relation to centric occlusion displacement. This may have influenced the perception of the skeletal discrepancy from the lateral cephalogram. The actual effects of this on the results were unclear, but we considered them likely to be minimal.

Effects of interventions

See: Table 1; Table 2; Table 3; Table 4; Table 5

1. Orthodontic treatment versus untreated control

Non‐surgical orthodontic treatments

Nine studies (n = 431) investigated the use of a non‐surgical orthodontic appliance compared to no treatment (Abdelnaby 2010; Alzabibi 2021; Arun 1994; Atalay 2010; Mandall 2010; Minase 2019; Vaughn 2005; Xu 2001; Yavan 2023). Five of the studies (n = 204) tested the facemask (Mandall 2010; Minase 2019; Vaughn 2005; Xu 2001; Yavan 2023). Vaughn 2005 tested two facemask groups (one with and one without RME), which we combined as the study showed no statistical difference between them for any outcome. Yavan 2023 also tested Reverse Forsus. Abdelnaby 2010 evaluated two different weights of chin cup (300 g or 600 g). Arun 1994 also evaluated chin cup, but data were not presented in a way that was suitable for meta‐analysis. One study each tested orthodontic removable traction appliance (Alzabibi 2021); tandem traction bow appliance (Atalay 2010); reverse Twin Block with lip pads and rapid maxillary expander (RME) (Minase 2019); and mandibular headgear (Arun 1994). See Table 1.

Prominence of lower front teeth – overjet

Overjet was assessed in four of the studies (Alzabibi 2021; Atalay 2010; Mandall 2010; Yavan 2023). We combined the results, which showed a benefit for non‐surgical orthodontic treatment groups compared to groups having no treatment (mean difference (MD) 5.03 mm, 95% CI 3.81 to 6.25; P < 0.001; 4 studies, 184 participants; moderate‐certainty evidence; Analysis 1.1). There was high heterogeneity in the analysis (P < 0.001; I² = 88%), but we chose to present the combined result as the direction was consistent, showing a clear benefit for all non‐surgical treatments tested. See Figure 4. See also Table 6 for a summary of the results from the individual studies.

1.1 — Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 1: Overjet

Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children ‐ analysis 1.1: overjet

1. Separate results for each non‐surgical orthodontic treatment versus no treatment.

Comparison	Studies	Results
Facemask versus untreated control	5 studies (n = 197) (Mandall 2010; Minase 2019; Vaughn 2005; Xu 2001; Yavan 2023). Vaughn 2005 tested two facemask groups: one with and one without RME; we combined these groups as the study showed no statistical difference between them for any outcome.	All five studies assessed ANB. Mandall 2010 and Yavan 2023 also assessed overjet, whilst Minase 2019 and Vaughn 2005 assessed Wits appraisal (another measure of the relative positions of the maxilla and mandible). In addition, Mandall 2010 reported on self‐esteem measures at the end of treatment and after 3 and 6 years of follow‐up. Mandall 2010 also considered adverse effects in terms of temporomandibular joint problems. Overjet Two studies reported overjet at 9 to 15 months (Mandall 2010; Yavan 2023). The pooled estimate, using the fixed‐effect model, was an MD of 5.04 mm (95% CI 4.29 to 5.80; P < 0.001; 92 participants) in favour of the facemask post‐treatment. There was high heterogeneity (P = 0.01; I² = 84%). At 3‐year follow‐up, Mandall 2010 found an MD of 2.50 mm (95% CI 1.21 to 3.79; P = 0.0001; 63 participants), but at 6‐year follow‐up, the difference had not been maintained (MD 1.30 mm, 95% CI −0.16 to 2.76 mm; P = 0.08; 65 participants). Relationship between upper and lower jaw ‐ ANB All five studies (n = 197) measured ANB (Mandall 2010; Minase 2019; Vaughn 2005; Xu 2001; Yavan 2023). The pooled estimate at 9 to 15 months, using the random‐effects model, was an MD of 3.60 (95% CI 2.68 to 4.52; P < 0.001) in favour of the facemask. There was substantial heterogeneity (P < 0.001; I² = 83%) between the studies, which may have been due to several factors including different inclusion criteria, different populations and different ages of the participants at the start of treatment. However, each study demonstrated a benefit for the facemask. One of the studies also assessed ANB at 3‐year follow‐up (n = 63) (Mandall 2010). Mandall 2010 found that a benefit persisted in favour of the facemask (MD 1.40°, 95% CI 0.43 to 2.37; P = 0.004), but this difference had been lost by the 6‐year follow‐up (n = 65): MD 0.70°, 95% CI ‐0.74 to 2.14; P = 0.34). Relationship between upper and lower jaw ‐ Wits appraisal Two studies (n = 72) assessed the relationship between the upper lower jaw using Wits appraisal (Minase 2019; Vaughn 2005). The pooled estimate, using the fixed‐effect model, was 3.58 mm (95% CI 2.78 to 4.37; P < 0.001) in favour of the facemask (with no heterogeneity between the studies: P = 0.54; I² = 0%). Other outcomes Self‐esteem and psychosocial impact, temporomandibular joint signs and symptoms, and the need for surgery in adulthood as perceived by clinicians were measured in one facemask study (Mandall 2010). See first comparison in Effects of interventions; Analysis 1.4; Analysis 2.3; Analysis 2.4; Analysis 2.5.
Chin cup versus untreated control	2 studies (n = 90) (Abdelnaby 2010; Arun 1994). We were unable to use the data from Arun 1994 in meta‐analysis as standard deviations were not reported.	Abdelnaby 2010 (n = 50) compared different force levels (300 g, 600 g) and both forces showed that the chin cup improved ANB (MD 1.96°, 95% CI 1.58 to 2.34; P < 0.001) and Wits appraisal (MD 4.87 mm, 95% CI 4.53 to 5.20; P < 0.001) when compared to the untreated control group (using the fixed‐effect model). Arun 1994 reported that the use of chin cup "led to an inhibition in the development of the upper face and an effective control of the vertical dimension in addition to the posterior positioning of the mandible".
Tandem traction bow appliance (TTBA) versus untreated control	1 study (n = 30) (Atalay 2010)	The study showed a benefit from the TTBA for both overjet (MD 3.30 mm, 95% CI 2.46 to 4.14; P < 0.0001), and ANB (MD 1.70°, 95% CI 1.09 to 2.31; P < 0.001).
Reverse Twin Block with lip pads and rapid maxillary expander (RME) versus untreated control	1 study (n = 26) (Minase 2019)	The study showed a benefit from the orthodontic treatment for ANB (MD 3.66°, 95% CI 2.73 to 4.59; P < 0.001) and Wits (MD 5.27 mm, 95% CI 4.04 to 6.50; P < 0.001).
Reverse Forsus versus untreated control	1 study (n = 22) (Yavan 2023)	The study showed a benefit from the Reverse Forsus for overjet (MD 5.54 mm, 95% CI 4.40 to 6.68; P < 0.0001) and ANB (MD 2.84°, 95% CI 1.89 to 3.79; P < 0.001).
Orthodontic removable traction appliance (ORTA) versus untreated control	1 study (n = 40) (Alzabibi 2021)	Overjet, ANB and Wits were reported and all demonstrated a benefit from the ORTA: overjet 6.20 mm (95% CI 5.52 to 6.88; P < 0.001); ANB 3.81° (95% CI 3.24 to 4.38; P < 0.001); Wits 5.96 mm (95% CI 4.71 to 7.21; P < 0.001).
Mandibular headgear versus untreated control	1 study (n = 60) (Arun 1994)	We were unable to use the data as standard deviations were not reported; however, P values reported for the Mann‐Whitney test showed that mandibular headgear provided a benefit for ANB compared to the control (P value < 0.001).

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ANB: A point–Nasion–B point; CI: confidence interval; g: grams; MD: mean difference; mm: millimetre; n: number; P: probability; RME: rapid maxillary expansion

One of the studies also assessed overjet at three‐ and six‐year follow‐up (Mandall 2010). Mandall 2010 found that a benefit persisted in favour of the facemask at three years (MD 2.50, 95% CI 1.21 to 3.79; P < 0.001; 63 participants; moderate‐certainty evidence; Analysis 2.1), but this difference was lost by the six‐year follow‐up (MD 1.30 mm, 95% CI ‐0.16 to 2.76; P = 0.08; 65 participants; low‐certainty evidence; Analysis 2.1).

2.1 — Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 1: Overjet

Relationship between upper and lower jaw – ANB

Eight studies (n = 345) measured the outcome ANB and were combined in meta‐analysis (Abdelnaby 2010; Alzabibi 2021; Atalay 2010; Mandall 2010; Minase 2019; Vaughn 2005; Xu 2001; Yavan 2023). The pooled estimate at nine to 12 months of follow‐up, using the random‐effects model, was 3.05° (95% CI 2.40 to 3.71; P < 0.001; moderate‐certainty evidence) in favour of orthodontic treatment (Analysis 1.2). There was substantial heterogeneity (P < 0.001; I² = 89%) between the studies, which may have been due to several factors, including different inclusion criteria, different populations and different ages of the participants at the start of treatment. However, each study demonstrated benefit from the facemask, and we thought it appropriate to present the pooled results. See Figure 5.

1.2 — Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 2: ANB

Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children ‐ analysis 1.1: ANB

Arun 1994 also measured ANB, but did not present data in a way that was suitable for meta‐analysis. The study assessed chin cup and mandibular headgear, and reported that they "were effective skeletally"; however, the results were in the order of 0.7° for chin cup and 0.5° for mandibular headgear, which are probably not clinically significant.

One of the studies also assessed ANB at three‐year follow‐up (n = 63) (Mandall 2010). Mandall 2010 found that a benefit persisted in favour of the facemask (MD 1.40°, 95% CI 0.43 to 2.37; P = 0.004; moderate‐certainty evidence; Analysis 2.2), but this difference had been lost by the six‐year follow‐up (n = 65): MD 0.70° (95% CI ‐0.74 to 2.14; P = 0.34; low‐certainty evidence; Analysis 2.2).

2.2 — Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 2: ANB

Relationship between upper and lower jaw – Wits appraisal

Four studies (n = 155) assessed the relationship between the upper and lower jaw using Wits appraisal (Abdelnaby 2010 (chin cup); (Alzabibi 2021 (ORTA); Minase 2019 (facemask, reverse Twin Block); Vaughn 2005 (facemask)). The pooled estimate, using the random‐effects model, was 4.75 mm (95% CI 4.15 to 5.35; P < 0.001; Analysis 1.3) in favour of the orthodontic treatment. There was high heterogeneity between the studies (P = 0.02; I² = 64%), but all clearly showed the effectiveness of the orthodontic intervention.

1.3 — Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 3: Wits

Psychosocial measures – self‐esteem

One study (n = 69 at 15 months, 63 at three years and 65 at six years) reported the Piers‐Harris self‐concept scale and OASIS assessment of self‐esteem (Mandall 2010). For the Piers‐Harris self‐concept scale, there was no evidence of a difference between the facemask and untreated control groups at any of the time points: the pooled estimate was 1.50 at one year (95% CI ‐0.96 to 3.96; P = 0.23; Analysis 1.4), 0.60 (95% CI ‐2.57 to 3.77; P = 0.71) at three years and ‐0.30 (95% CI ‐4.17 to 3.57; P = 0.88) at six years (Analysis 2.3). The OASIS assessment of self‐esteem demonstrated a benefit for the facemask group at the post‐treatment stage (MD ‐4.00, 95% CI ‐7.40 to ‐0.60; P = 0.02; Analysis 1.4); however, this difference was lost by the three‐year follow‐up (MD ‐3.40, 95% CI ‐7.99 to 1.19; P = 0.15) and six‐year follow‐up (MD ‐2.20, 95% CI ‐7.31 to 2.91; P = 0.40; Analysis 2.4).

1.4 — Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 4: Piers‐Harris self‐concept scale

2.3 — Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 3: Piers‐Harris self‐concept scale

2.4 — Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 4: Oral Aesthetic Subjective Impact Score (OASIS)

Surgery in adulthood

One study (n = 65) assessed the perceived need for surgery in adulthood, at the six‐year follow‐up (Mandall 2010). The mean age was 15 years (SD 10.3 months) in the facemask group and 15.3 years (SD 10.1 months) in the control group. There was a significant difference in perceived need for surgery (odds ratio 3.34, 95% CI 1.21 to 9.24; P = 0.02; Analysis 2.5), favouring the facemask group. The number needed to treat for an additional beneficial outcome was 3 (95% CI 2 to 20).

2.5 — Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 5: Need for surgery in adulthood (6‐year follow‐up)

Adverse effects

One study reported on temporomandibular joint (TMJ) signs and symptoms (Mandall 2010). These were assessed by looking at pain (lateral and intra‐auricular), clicking, crepitus, locking, muscle tenderness (temporalis, masseter and lateral pterygoid), and restriction of jaw movement (maximum opening and lateral movement). In addition, the presence of forward mandibular displacement on closure was recorded. The trial authors noted that no statistical analysis was carried out because of the low prevalence of TMJ signs and symptoms at all time points. In the paper documenting the six‐year follow‐up, Mandall 2010 reported that there were no adverse effects from the facemask intervention.

Surgically‐anchored appliances

One three‐arm study (n = 30) evaluated miniplates with facemask or with Class III elastics versus no treatment (Elnagar 2016). The study found evidence that both techniques were effective for the outcomes overjet (MD 7.69 mm, 95% CI 6.99 to 8.40; P < 0.001; low‐certainty evidence; Analysis 3.1) and ANB (MD 5.20°, 95% CI 4.48 to 5.92; P < 0.001; low‐certainty evidence; Analysis 3.2). See Table 2.

3.1 — Comparison 3: Surgical orthodontic treatment versus untreated control, Outcome 1: Overjet

3.2 — Comparison 3: Surgical orthodontic treatment versus untreated control, Outcome 2: ANB

2. One orthodontic treatment versus another

Facemask (RME) or modified facemask versus other non‐surgical orthodontic treatments

We conducted meta‐analyses combining the studies of facemask therapy versus non‐surgical comparators at the end of treatment (overjet MD 0.96 mm, 95% CI ‐0.12 to 2.04; P = 0.08; 4 studies, 136 participants; very low‐certainty evidence; Analysis 4.1; ANB MD 0.11, 95% CI ‐0.54 to 0.77; P = 0.73; 8 studies, 285 participants; very low‐certainty evidence; Analysis 4.2). We judged that the high heterogeneity in the synthesised results made the findings unreliable. We present the results for the individual comparisons below, but as each one is based on a single small study at high risk of detection bias, the findings should be interpreted with caution. No longer‐term follow‐up was measured in any of the studies. See Table 3.

4.1 — Comparison 4: Facemask (RME) or modified facemask versus other non‐surgical appliance, Outcome 1: Overjet

4.2 — Comparison 4: Facemask (RME) or modified facemask versus other non‐surgical appliance, Outcome 2: ANB

Facemask (RME) versus mini maxillary protractor

One study (n = 32) compared the use of a facemask with rapid maxillary expansion versus a mini maxillary protractor (Celikoglu 2015). The study found a difference between the interventions for ANB (MD ‐0.75°, 95% CI ‐1.49 to ‐0.01; P = 0.05; Analysis 4.2.1) in favour of the mini maxillary protractor, but no evidence of a difference for overjet (MD ‐0.06 mm, 95% CI ‐1.52 to 1.40; P = 0.94; Analysis 4.1.1).

Facemask (RME) versus Pushing Splints

One study (n = 42)compared the use of a facemask versus Pushing Splints (Galeotti 2021). The study found no evidence of a difference between the techniques for overjet (MD 0.8 mm, 95% CI ‐0.37 to 1.97; P = 0.18; Analysis 4.1.2) or Wits (MD 0.70 mm, 95% CI ‐0.60 to 2.0; P = 0.29; Analysis 4.3.3). The study found evidence of a difference in favour of the facemask for ANPog (which is equivalent to ANB) (MD 1.40°, 95% CI 0.29 to 2.51; P = 0.01; Analysis 4.2.2). In terms of adverse effects, there was occasional skin irritation on the chin and three breakages, one in the facemask group and two in the Pushing Splints group.

4.3 — Comparison 4: Facemask (RME) or modified facemask versus other non‐surgical appliance, Outcome 3: Wits appraisal

Facemask (RME) versus modified tandem appliance

One study (n = 32) compared a modified tandem appliance versus facemask (Husson 2016). It found a benefit in favour of the facemask for overjet (MD 2.28 mm, 95% CI 1.35 to 3.21; P < 0.001; Analysis 4.1.3), but no evidence of a difference between the appliances for ANB (MD 0.25°, 95% CI ‐0.39 to 0.89; P = 0.44; Analysis 4.2.3).

Facemask (RME) versus Reverse Forsus

One study (n = 30)compared the use of a facemask versus Reverse Forsus appliance (Yavan 2023). The study found evidence of a difference in favour of the facemask for ANB (MD 1.59°, 95% CI 0.80 to 2.38; P < 0.001; Analysis 4.2.4), but no evidence of a difference between the interventions for overjet (MD 0.46 mm, 95% CI ‐0.90 to 1.82; P = 0.51; Analysis 4.1.4).

Facemask (RME) versus reverse Twin Block with lip pads and rapid maxillary expansion (RME)

One study (n = 26) compared the use of a facemask versus a reverse Twin Block with lip pads and RME (Minase 2019). The study found evidence of a difference between the interventions for ANB (MD ‐1.04°, 95% CI ‐2.07 to ‐0.01; P = 0.05; Analysis 4.2.5) and Wits (MD ‐1.85 mm, 95% CI ‐3.18 to ‐0.52; P = 0.007; Analysis 4.3.1) in favour of the reverse Twin Block with lip pads and RME.

Facemask (RME) versus reverse chin cup

One study (n = 42) compared the use of a facemask versus a reverse chin cup (Showkatbakhsh 2012). The study found no evidence of a difference between the interventions for ANB (MD 0.20°, 95% CI ‐0.71 to 1.11; P = 0.67; Analysis 4.2.6).

Facemask (RME) versus tongue appliance

One study (n = 47) compared the use of a facemask versus a tongue appliance (Showkatbakhsh 2013). The study found no evidence of a difference between the interventions for ANB (MD ‐0.60°, 95% CI ‐1.41 to 0.21; P = 0.14; Analysis 4.2.7).

Facemask (with frame fixation) versus Frankel III appliance

One study (n = 34) compared a facemask with frame internal fixation versus a Frankel III appliance (Zhang 2018). The study found no evidence of a difference between the interventions for ANB (MD ‐0.11°, 95% CI ‐1.29 to 1.07; P = 0.86; Analysis 4.2.8) or Wits (MD 0.06 mm, 95% CI ‐0.26 to 0.38; P = 0.71; Analysis 4.3.2).

Facemask (RME) or modified facemask versus a surgically‐anchored appliance

We included four studies in this comparison: Ge 2012, which compared a facemask with rapid maxillary expander (RME) to a facemask anchored with miniscrews; Jamilian 2011, which compared a facemask (RME) to an upper removable appliance (URA) with miniscrews and Class III elastics; Liang 2021, which compared a facemask (RME) to surgical miniplates (facemask); and Seiryu 2020, which compared a facemask with transpalatal arch (TPA) to a facemask with TPA and miniscrew. See Table 4.

Prominence of lower front teeth – overjet

One study (n = 43)compared the use of a facemask with RME to a facemask anchored with miniscrews (Ge 2012). The study found no evidence of a difference between the techniques for overjet (MD ‐0.40 mm, 95% CI ‐1.30 to 0.50; P = 0.38; very low‐certainty evidence; Analysis 5.1).

5.1 — Comparison 5: Facemask (RME) or modified facemask versus surgically‐anchored appliance, Outcome 1: Overjet

Relationship between upper and lower jaw – ANB

Four studies (n = 143) measured the outcome ANB (Ge 2012; Jamilian 2011; Liang 2021; Seiryu 2020). The pooled estimate at one‐year follow‐up, using the random‐effects model, showed no evidence of a difference in treatment effect (MD ‐0.35°, 95% CI ‐0.78 to 0.07; P = 0.10; low‐certainty evidence; Analysis 5.2). There was no heterogeneity in treatment effect (I² = 0%; P = 0.51) .

5.2 — Comparison 5: Facemask (RME) or modified facemask versus surgically‐anchored appliance, Outcome 2: ANB

Relationship between upper and lower jaw – Wits

One study (n = 43)compared the use of a facemask with miniscrews to a facemask with a rapid maxillary expander (Ge 2012). The study found no evidence of a difference between the techniques for Wits (MD 0.50 mm, 95% CI ‐1.27 to 2.27; P = 0.58; Analysis 5.3).

5.3 — Comparison 5: Facemask (RME) or modified facemask versus surgically‐anchored appliance, Outcome 3: Wits

Mandibular headgear versus chin cup

One study (n = 60) compared mandibular headgear to a chin cup (Arun 1994). It provided outcome data for ANB, but no standard deviations were given and P values from the Mann‐Whitney test were presented, so we were unable to use the data. The study reported that there was no statistically significant difference between the two active interventions (P > 0.05).

Bone‐anchored intermaxillary traction versus removable mandibular retractor

One study (n = 38) compared the use of bone‐anchored intermaxillary traction (BAIMT) to a removable mandibular retractor (RMR) (Majanni 2016). The study found a difference between the two techniques in favour of BAIMT for overjet (MD 0.70 mm, 95% CI 0.25 to 1.15; P = 0.002; Analysis 6.1) and ANB (MD 1.77°, 95% CI 1.58 to 1.96; P < 0.001; Analysis 6.2), at one year after the start of treatment.

6.1 — Comparison 6: Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR), Outcome 1: Overjet

6.2 — Comparison 6: Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR), Outcome 2: ANB

The authors also investigated adverse effects (for example, pain and discomfort), and acceptance of the appliances, using a questionnaire on a sample when further participants had been recruited. They reported that participants treated with the BAIMT system had higher levels of pain early on in treatment compared to those in the RMR group (P < 0.001). Treatment with removable mandibular retractors negatively impacted self‐confidence more than treatment with BAIMT; the removable mandibular retractor group had higher scores for 'lack of confidence' at all time points (P < 0.001).

3. Variations of the same orthodontic treatment

Facemask variations

Facemask (rapid maxillary expansion (RME)) versus facemask alone

Two studies (n = 60) investigated the use of a facemask with expansion versus facemask alone (Ma 2009; Vaughn 2005). The outcomes considered by both studies were ANB and Wits appraisal. Ma 2009 also reported overjet. See Table 5.

Prominence of lower front teeth ‐ overjet

One study (n = 31) found a mean difference of 1.86 mm in overjet post‐treatment (95% CI 0.39 to 3.33; P = 0.01; low‐certainty evidence; Analysis 7.1), in favour of facemask only.

7.1 — Comparison 7: Facemask (RME) versus facemask only, Outcome 1: Overjet

Relationship between upper and lower jaw ‐ ANB

Two studies (n = 60) reported ANB and demonstrated no evidence of a difference between treatment using a facemask with or without the use of rapid maxillary expansion. The pooled estimate, using the fixed‐effect model, was ‐0.15° (95% CI ‐0.94 to 0.64; P = 0.71; low‐certainty evidence; Analysis 7.2). There was no heterogeneity between the studies (P = 0.97; I² = 0%).

7.2 — Comparison 7: Facemask (RME) versus facemask only, Outcome 2: ANB

Relationship between upper and lower jaw ‐ Wits appraisal

Two studies (n = 60) reported Wits appraisal and found no difference between the groups. The pooled estimate, using the fixed‐effect model, was 0.1 mm (95% CI ‐1.08 to 1.29; P = 0.86; Analysis 7.3). There was no heterogeneity between the studies (P = 0.90; I² = 0%).

7.3 — Comparison 7: Facemask (RME) versus facemask only, Outcome 3: Wits

Facemask (RME) versus facemask (Alt‐RAMEC)

Four studies (n = 131) compared a facemask with a rapid maxillary expander to a facemask with rapid maxillary expander using alternating expansion and constriction (Chen 2012; Liu 2013; Liu 2015; Yao 2015). These studies reported ANB, Wits and A‐Nasion perpendicular (A‐NPerp). See Table 5.

Relationship between upper and lower jaw ‐ ANB

All four studies (n = 131) assessed the ANB angle. The pooled estimate, using the random‐effects model, found no evidence of a difference between the two techniques (MD ‐0.46°,95% CI ‐1.03 to 0.10; P = 0.11; low‐certainty evidence; Analysis 8.1). There was some heterogeneity between the studies (P = 0.24, I² = 28%).

8.1 — Comparison 8: Facemask (RME) versus facemask (Alt‐RAMEC), Outcome 1: ANB

Relationship between upper and lower jaw ‐ Wits

Three studies (n = 97) assessed the Wits appraisal (Chen 2012; Liu 2013; Liu 2015). The pooled estimate, using the fixed‐effect model, found no evidence of a difference between the two techniques (MD ‐0.38 mm, 95% CI ‐1.37 to 0.60; P = 0.44; Analysis 8.2). There was no heterogeneity between the studies (P = 0.94, I² = 0%).

8.2 — Comparison 8: Facemask (RME) versus facemask (Alt‐RAMEC), Outcome 2: Wits

Relationship between upper and lower jaw ‐ A‐Nasion Perpendicular

One study (n = 34) found evidence of a difference between the two techniques for A‐NPerp (Yao 2015), in favour of the facemask with Alt‐RAMEC (MD 1.13 mm, 95% CI 0.23 to 2.03; P = 0.01; Analysis 8.3).

8.3 — Comparison 8: Facemask (RME) versus facemask (Alt‐RAMEC), Outcome 3: A‐NPerp

Facemask after alternating rapid maxillary expansion and constriction (Alt‐RAMEC) versus facemask started simultaneously with Alt‐RAMEC

One study (n = 30)compared the use of a facemask after alternating rapid maxillary expansion and constriction (Alt‐RAMEC) to facemask treatment started at the same time as Alt‐RAMEC (Canturk 2015). The study found there was no evidence of a difference between the two approaches for the outcomes overjet (MD 0.22 mm, 95% CI ‐0.68 to 1.12; P = 0.63; Analysis 9.1), ANB (MD 0.40°, 95% CI ‐0.42 to 1.22; P = 0.34; Analysis 9.1) and Wits (MD 0.51 mm, 95% CI ‐0.69 to 1.71; P = 0.41; Analysis 9.3).

9.1 — Comparison 9: Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC), Outcome 1: Overjet

9.3 — Comparison 9: Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC), Outcome 3: Wits

Facemask (RME) versus facemask (Nanda)

One study (n = 20) compared the Nanda facemask to a conventional facemask (Keles 2002). There was evidence of a difference in ANB between the groups in favour of the Nanda facemask (MD 1.29°, 95% CI 0.16 to 2.42; P = 0.02; Analysis 10.1).

10.1 — Comparison 10: Facemask (RME) versus facemask (Nanda), Outcome 1: ANB

Chin cup variations

600 g chin cup versus 300 g chin cup

One study (n = 40) compared the outcome data on the use of 600 g versus 300 g of force applied to a chin cup (Abdelnaby 2010). There was no evidence of a difference between forces for ANB (MD 0.10°, 95% CI ‐0.31 to 0.51; P = 0.63; Analysis 11.1) or Wits appraisal (MD ‐0.30 mm, 95% CI ‐1.12 to 0.52; P = 0.47; Analysis 11.2).

11.1 — Comparison 11: Chin cup (600 g) versus chin cup (300 g), Outcome 1: ANB

11.2 — Comparison 11: Chin cup (600 g) versus chin cup (300 g), Outcome 2: Wits

Surgical variations

Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics

One study (n = 35) compared the hybrid Hyrax (RME) with miniscrews and Class III elastics to the conventional Hyrax (RME) with miniscrews and Class III elastics (Miranda 2021). Three outcomes, overjet, ANB and Wits, were reported and all demonstrated no evidence of a difference between the two techniques: overjet 0.91 mm (95% CI ‐0.56 to 2.38; P = 0.22; Analysis 12.1); ANB 0.55° (95% CI ‐0.40 to 1.50; P = 0.26; Analysis 12.2); Wits 0.28 mm (95% CI ‐1.08 to 1.64; P = 0.69; Analysis 12.3).

12.1 — Comparison 12: Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics, Outcome 1: Overjet

12.2 — Comparison 12: Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics, Outcome 2: ANB

12.3 — Comparison 12: Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics, Outcome 3: Wits

Surgical miniplates with facemask versus surgical miniplates with Class III elastics

One study (n = 20) compared surgical miniplates with facemask to surgical miniplates with Class III elastics (Elnagar 2016). The study found no evidence of a difference between the two techniques for the outcomes overjet (MD 0.02 mm, 95% CI ‐1.23 to 1.27; P = 0.98; Analysis 13.1) and ANB (MD ‐0.05°, 95% CI ‐1.24 to 1.14; P = 0.93; Analysis 13.2).

13.1 — Comparison 13: Surgical miniplates (facemask) versus surgical miniplates (Class III elastics), Outcome 1: Overjet

13.2 — Comparison 13: Surgical miniplates (facemask) versus surgical miniplates (Class III elastics), Outcome 2: ANB

Discussion

Summary of main results

We included 29 RCTs (reported in 36 articles), involving 1169 participants, of whom 1102 were analysed.

No‐treatment comparisons – effectiveness outcomes

Ten studies evaluated the effectiveness of orthodontic treatment compared to no treatment. Both surgical and non‐surgical treatments evaluated were effective for reducing the prominence of the lower front teeth and improving the jaw relationship.

The non‐surgical treatment most commonly evaluated was the facemask; its effectiveness was evaluated in five studies. Two studies evaluated the chin cup, with either 300 g or 600 g of force applied (there appeared to be no advantage of the higher force). One study each evaluated mandibular headgear, orthodontic removable traction appliance (ORTA), tandem traction bow appliance, reverse Twin Block with lip pads (RME), and Reverse Forsus. The studies all showed an increase in overjet and ANB at one‐year follow‐up (one study evaluated participants at nine months). Our meta‐analysis of all non‐surgical treatments showed that the average overjet increase at the end of treatment was 5.03 mm, and for ANB, it was 3.05 degrees. Four studies (two facemask, one ORTA and one reverse Twin Block with lip pads and rapid maxillary expander) used the Wits appraisal to assess skeletal change and found an average of 4.50 mm improvement at the end of treatment.

Only facemask was assessed beyond the end of treatment. One study followed children who had received facemask treatment for six years. It showed that the overjet increase was reduced to 2.5 mm at three years and to 1.3 mm at six years, and the ANB increase was reduced to 1.4 degrees at three years and to 0.7 degrees at six years.

These findings suggest that, although treatment is beneficial in the short term, its benefits may be lost over time. Nevertheless, one study evaluated the need for surgical correction of participants' jaw position, assessed by clinicians who were blinded to allocation group. It found that six years after treatment, clinicians perceived that 3.34 times as many participants who had not received facemask treatment as had received facemask treatment would require orthognathic surgery. To date, there is no evidence about the actual number of participants undergoing orthognathic surgery.

Head‐to‐head comparisons – effectiveness outcomes

Facemask versus other orthodontic treatments

Facemask treatment was compared with eight other orthodontic treatments: the modified tandem appliance; reverse chin cup; tongue appliance; reverse Twin Block with lip pads and RME; Frankel III; mini maxillary protractor; Pushing Splints; and Reverse Forsus appliance. Four studies assessed overjet, and to assess the relationship between the upper and lower jaw, seven studies used the ANB angle, three used the Wits appraisal and one used the A‐nasion‐pogonion (ANPog) angle. Our meta‐analyses did not show facemask to be inferior to other treatments, but the results were mixed, with high heterogeneity.

For overjet, three studies found no difference in treatment effect and one study found that the facemask increased the overjet by 1.28 mm compared with the tandem traction bow appliance.

For ANB, four studies found no difference in treatment effect; one study found that the facemask increased ANB by 1.59 mm compared with the Reverse Forsus appliance (Yavan 2023). For two studies, the facemask was less effective; the reverse Twin Block appliance (with lip pads and RME) increased the ANB by 1.04 degrees and the mini‐maxillary protractor increased it by 0.75 degrees.

For the Wits appraisal, two studies found no difference in treatment effect and one study found that the reverse Twin Block appliance (with lip pads and RME) increased the Wits appraisal by 1.85 mm, compared with the facemask.

In one study, facemask treatment increased the ANPog by 1.4 degrees compared to Pushing Splints.

Overall, the facemask treatment was no more effective at improving all outcomes, in any one study, than any of the other orthodontic interventions assessed. The reverse Twin Block appliance (with lip pads and RME) was found to be more effective than the facemask for improving the skeletal relationship as assessed by ANB and the Wits appraisal; however, the differences were small (1.04 degrees; 1.85 mm) and may not be clinically significant. The effect of the reverse Twin Block on overjet was not assessed.

None of these studies had a follow‐up assessment beyond the end of treatment, so we do not know if the changes were maintained.

Facemask versus surgically‐anchored appliances

Four studies compared conventional facemask treatment with facemasks that were anchored with surgical interventions, including miniscrews (three studies) and miniplates (one study). One study assessed overjet, four studies used the ANB angle, and one study used the Wits appraisal to assess differences in the upper and lower jaw relationship. Overall, there appeared to be no or little advantage in the addition of surgical anchorage, in the form of miniscrews or miniplates, over the effect of conventional facemask treatment alone.

Surgical versus non‐surgical intervention

One study found treatment using bone‐anchored intermaxillary traction (BAIMT) increased overjet by 0.7 mm and ANB by 1.77 degrees, compared to a removable mandibular retractor (RMR), when measured at the end of treatment. However, although BAIMT produced significantly more change than an RMR, this may not be clinically significant and may have been more traumatic to the participants as placement and removal of the bone anchor plates involves a surgical procedure.

Facemask variations

Two studies found no difference between facemask treatment with rapid maxillary expansion (RME) or without RME for ANB or Wits appraisal. One study found a difference of 1.86 mm in overjet favouring facemask without RME.

Meta‐analyses showed no evidence of a difference in ANB (four studies) or Wits (three studies) between conventional and alternating RME when used with a facemask. One study found that alternating RME between expansion and constriction may have increased A‐Nasion Perpendicular by 1.13 mm compared to a conventional facemask.

One study showed that it made no difference to the overjet, ANB or Wits appraisal whether the facemask treatment was carried out before or while the alternating RME was undertaken.

One study found that the Nanda facemask (force applied parallel to the Frankfort plane and 20 mm above the occlusal plane) increased ANB by 1.29 degrees compared to a conventional facemask (force applied at 30° to and at the level of the occlusal plane).

Chin cup variations

For ANB and Wits appraisal, one study found no difference in treatment effect between chin cup treatment with either a 600 g or 300 g force applied, which suggests that the additional force may not be of benefit in terms of the skeletal change produced.

Surgical variations

One study found no differences in overjet, ANB or Wits appraisal between hybrid Hyrax and conventional Hyrax appliances (with miniscrews and Class III elastics). Another study found no differences in overjet or ANB regardless of whether force was applied to surgical miniplates with a facemask or with Class III elastics.

Patient‐reported outcomes

Only two studies reported patient‐reported outcomes. Majanni 2016 designed and piloted a questionnaire to investigate pain, discomfort, self‐confidence and acceptance of orthodontic appliances, which showed that BAIMT was more painful than RMR early on in treatment, but RMR negatively impacted self‐confidence more than BAIMT. Mandall 2000 used validated questionnaires to assess self‐concept and the impact of malocclusion and oral self‐perception after treatment with facemask. No improvement in self‐concept was found at any time point. However, an improvement in Oral Aesthetic Subjective Impact Score (OASIS) score was found at one year, though this was lost at the three‐year and six‐year follow‐up assessments.

Harm

Only four studies reported on the outcome of harm to participants. Seiryu 2020 reported "no serious harm" and Mandall 2000 found no changes in temporomandibular joint (TMJ) signs or symptoms as a result of facemask therapy. Galeotti 2021 reported that some children had skin irritation problems under the chin cup of the facemask. As noted above, Majanni 2016 reported that participants treated with BAIMT had higher levels of pain early in treatment compared to those in the RMR group, but that the RMR treatment negatively impacted self‐confidence more than treatment with BAIMT.

Overall completeness and applicability of evidence

Overall, we found 29 studies that investigated comparisons of interventions to treat prominent lower front teeth in children and reported multiple outcomes. Twenty‐three of the studies investigated the facemask, and three, the chin cup. One study each evaluated the Tandem Traction Bow appliance, mandibular headgear, removable mandibular retractor, tongue appliance, reverse Twin Block, Frankel III appliance, mini maxillary protractor, Pushing Splints, Reverse Forsus and the ORTA (orthodontic removable traction appliance). In terms of surgical treatments, four studies investigated miniscrews and three, surgical miniplates.

Only one study investigated outcomes beyond the initial treatment phase and, to date, that was at three and six years' follow‐up (Mandall 2010). This has major implications for the applicability of the evidence contained in this review because the ultimate aim of early treatment for a Class III malocclusion is to reduce the need for surgery to correct the jaw positions in adulthood. The current evidence does not allow us to assess if any of the interventions have succeeded in this aim due to their short‐term nature, with the only long‐term study assessing only the perceived need for surgery rather than the actual number of participants receiving surgery in adulthood.

The concern of many children and parents who seek treatment for a Class III malocclusion is that their lower front teeth meet the wrong way round, i.e. a reverse overjet; however, only 13 of the 29 studies reported overjet as an outcome (Alzabibi 2021; Atalay 2010; Canturk 2015; Celikoglu 2015; Elnagar 2016; Galeotti 2021; Ge 2012; Husson 2016; Ma 2009; Majanni 2016; Mandall 2010; Miranda 2021; Yavan 2023).

Only 12 studies carried out an a priori sample size calculation (Alzabibi 2021; Canturk 2015; Celikoglu 2015; Galeotti 2021; Husson 2016; Majanni 2016; Mandall 2010; Minase 2019; Miranda 2021; Showkatbakhsh 2012; Showkatbakhsh 2013; Yavan 2023). One study based the sample size on a previous study (Seiryu 2020). Seventeen studies did not describe a sample size calculation (Abdelnaby 2010; Arun 1994; Atalay 2010; Chen 2012; Elnagar 2016; Ge 2012; Jamilian 2011; Keles 2002; Liang 2021; Liu 2013; Liu 2015; Ma 2009; Seiryu 2020; Vaughn 2005; Xu 2001; Yao 2015; Zhang 2018).

The lack of accurate reporting, especially with respect to unclear methodology and, in one case, missing statistical data, means much of the evidence can provide only low to very low certainty in the results.

Certainty of the evidence

The overall certainty of the evidence can be seen in the summary of findings tables (Table 1; Table 2; Table 3; Table 4; Table 5).

We graded the evidence regarding overjet and ANB changes, when comparing participants receiving non‐surgical orthodontic treatment with an untreated control group, as moderate to low certainty. This implies that further research is likely to have an important impact on our confidence in the estimate of effect. It may change the estimate, but is unlikely to overturn the direction of the effect.

We graded the evidence regarding overjet and ANB changes, when comparing the use of a surgical orthodontic treatment with an untreated control, as low certainty.

We judged all other comparisons and outcomes to have low‐ or very low‐certainty evidence. The main reason for this was the inability of investigators to blind participants to which intervention they were receiving. Other reasons for downgrading the level of evidence included imprecision or inconsistency (high level of statistical heterogeneity) in the results and unclear or high risk of other types of bias in the included studies.

Potential biases in the review process

This update to the Watkinson 2013 version of the review has been undertaken by a different review team, led by DO, ST and JH. There have been a variety of authors through the different iterations of this review, with JH being the common link from the protocol through to this 2024 update. We have continued to adhere to Cochrane standards and methods throughout the updating process.

We debated the distinction between surgical and non‐surgical interventions, and decided to define surgical interventions as those that pierced the mucosa/gum, so this included the less invasive temporary anchorage devices/miniscrews as well as the more invasive types of surgical (mini‐)plate.

Agreements and disagreements with other studies or reviews

This 2024 update reaches similar conclusions to those seen in other systematic reviews in the last 10 years (Almuzian 2018; Arqub 2021; Chatzoudi 2014; Clemente 2018; Cordasco 2014; Cornelis 2021; Farhadian 2019; Foersch 2015; Hu 2022; Huang 2018; Hui 2020; Jiménez‐Silva 2018; Jamilian 2016; Kakali 2021; Lee 2021; Meyns 2018; Morales‐Fernandez 2013; Lin 2018; Rongo 2017; Wu 2020; Yepes 2014). Many of these reviews have included both randomised and non‐randomised studies and have differing inclusion criteria and outcomes, so comparisons with this Cochrane review should be made carefully.

With similar inclusion criteria and included studies as our review, Woon 2017 concluded there was a moderate amount of evidence to show that early treatment with a facemask resulted in positive improvements in both skeletal and dental outcomes in the short term, with lack of evidence for long‐term benefits, which is consistent with the conclusions of this Cochrane review.

Wang 2022 concluded that bone‐anchored maxillary protraction can promote greater maxillary forward movement and correct the Class III intermaxillary relationship better than tooth‐borne appliances, whereas we found only small benefits (0.7 mm increase in overjet and 1.77 degrees in ANB) with BAIMT compared to a removable mandibular retractor. However, Wang 2022 included 18 studies, of which only four were RCTs, so the treatment effect of bone‐anchored appliances is likely to have been overestimated.

Authors' conclusions

Implications for practice.

We found moderate‐certainty evidence that non‐surgical orthodontic treatment (including facemask, reverse Twin Block, orthodontic removable traction appliance, chin cup, tandem traction bow appliance and mandibular headgear) improves bite, jaw relationship and/or self‐perception immediately post‐treatment. Only one study evaluated long‐term outcomes and found that the benefits of facemask were observable, though reduced, three years after the end of treatment, and appeared to have been lost by six years. However, the perceived need for jaw surgery was much less likely for those who had received facemask treatment in childhood than for those who had not received any orthodontic treatment for their prominent lower front teeth.

We found low‐certainty evidence that surgical orthodontic treatment (specifically, surgical miniplates, either with Class III elastics or facemask) was also effective for improving the bite and jaw relationship, when measured at the end of treatment.

The evidence for head‐to‐head comparisons of different orthodontic treatments was based mainly on single studies at high risk of bias due to lack of blinding, so we cannot draw any reliable conclusions about the results.

Implications for research.

In view of the quality of the studies identified in this systematic review, it has been difficult to draw definitive conclusions. This review suggests the need for more long‐term, well‐designed and well‐reported randomised controlled clinical studies to assess the efficacy of early orthodontic treatment of prominent lower front teeth.

When designing future studies, the following points need to be considered.

Clear inclusion and exclusion criteria should be set.
An a priori sample size calculation should be carried out based on an appropriate primary outcome.
Novel surgical and non‐surgical appliances should be compared with conventional facemask therapy or an untreated control rather than with variations of the same appliance.
Reverse Twin Block, with lip pads and rapid maxillary expander (RME), and the orthodontic removable traction appliance (ORTA) need to be compared with conventional facemask therapy.
Outcomes relevant to the patient (not solely a list of cephalometric measures) should be used. These should include those in the proposed orthodontic core outcome set (Tsichlaki 2020).
We recommend the following outcomes be measured:
- breakages;
- adverse effects on the teeth (caries, white spot lesions);
- adverse effects on the gums or roots;
- skeletal relationship (e.g. ANB (A point, nasion, B point) angle);
- occlusion, including:
  - overjet (mm);
  - overjet change (mm);
  - correction of an anterior crossbite (yes/no).
- stability of changes one year after treatment and ideally, at three and 10 years after treatment;
- patient‐related adherence, including wear of the appliance, attendance at appointments, length of treatment;
- psychosocial measures using validated questionnaires.
We recommend the following methodological considerations for outcome assessment:
- recording of discrepancies between intercuspal position and retruded contact position;
- taking all lateral cephalograms in the retruded contact position;
- assessing and reporting the reliability of measurements;
- Bonferroni correction of the significance level when testing multiple cephalometric variables.
Consensus should be sought on the minimal clinically important differences for core outcomes.
Long‐term follow‐up, to assess if the treatment has been successful at the end of growth, should be planned, particularly the ultimate outcome of whether orthognathic surgery was carried out in adulthood.
Conduct and reporting of the clinical trials would be improved by adherence to the CONSORT guidelines, including the extension for non‐pharmacological treatments, to ensure that all relevant information is collected and reported.

What's new

Date	Event	Description
10 April 2024	New citation required and conclusions have changed	The updated review builds on the previous one from 2013. It has much fuller conclusions as it includes many new studies and comparisons.
10 April 2024	New search has been performed	Updated search and addition of two new authors

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History

Protocol first published: Issue 1, 2002 Review first published: Issue 9, 2013

Date	Event	Description
23 June 2008	Amended	Converted to new review format.

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Notes

This is an update of a review originally published in 2013 (Watkinson 2013).

Acknowledgements

We thank Cochrane Oral Health, especially our editors Anne‐Marie Glenny, Fang Hua and Lucy O'Malley, and Managing Editor Laura MacDonald. We thank Anne Littlewood for developing the search strategy and undertaking the electronic searches. We thank Ross Hobson, Declan Millett and Ahmed El‐Angbawi for their peer review comments, and Faith Armitage, Cochrane Central Production Service, for the final copy edit.

We would like to acknowledge the contributions of Kevin O'Brien, Bill Shaw and Sue Furness to the protocol and earlier versions of this review. We would like to thank Zipporah Iheozor‐Ejiozor (Cochrane Oral Health) for her help with the completion of the last version of the review. The foundation of the current review was originally undertaken by Sylvia Bickley, Jayne Harrison and Kevin O'Brien.

We would like to thank the following authors of studies who helped the review process with clarification and in providing unpublished information and data where required: Dr Teruko Takano‐Yamaoto, Professor Mohammad Y Hajeer, Dr Umal H Doshi, Dr Hakan El, Professor Ayca Arman‐Ozcirpici, Professor Mohammed H Elnagar, Professor Abdolreza Jamilian, Dr Shuran Liang, Dr Felicia Miranda and Dr Mehmet A Yavan.

We are grateful to the following translators for enabling us to include data from publications in languages other than English: Dr Liyuan Ma, Dr Lina Liao, Professor Chengge Hua, Professor Zongdao Shi, Christina Ketian Wang and May Wong.

Appendices

Appendix 1. Cochrane Oral Health Trials Register search strategy

A search was undertaken using the Cochrane Register of Studies and the search strategy below:

#1 ("prominent lower front teeth" or underbite* or under‐bite* or "under bite*" or reverse‐bite* or "reverse bite*" or prognath* or "Malocclusion Angle Class III" or "Angle* class III") AND (INREGISTER) #2 (("Class III" AND (malocclusion or bite))) AND (INREGISTER) #3 (#1 or #2) AND (INREGISTER) #4 (("orthodontic appliance*" OR "orthodontic device*" OR "removable appliance*" OR "removable device*" OR "functional appliance*" OR "functional device*" OR "fixed appliance*" OR "growth modif*" or brace* OR ((extraoral OR "extra oral" or extra‐oral) AND traction) OR "chin cap*" or chin‐cap* or chincap* OR "chin cup*" or chin‐cup* or chincup* or "face mask*" OR facemask* or face‐mask* OR "reverse head gear" OR "reverse head‐gear")) AND (INREGISTER) #5 (((orthopedic* OR orthopaedic*) AND (dental OR orthodontic* OR facial))) AND (INREGISTER) #6 (#4 or #5) AND (INREGISTER) #7 (#3 AND #6) AND (INREGISTER)

A previous search of the Register was undertaken in July 2011 using the Procite software and the search strategy below:

(("prominent lower front teeth" or underbite* or under‐bite* or "under bite*" or reverse‐bite* or "reverse bite*" or prognath* or "Malocclusion Angle Class III" OR "Angle* class III" OR ("Class III" AND (malocclusion* OR bite))) AND ("orthodontic appliance*" OR "orthodontic device*" OR "removable appliance*" OR "removable device*" OR "functional appliance*" OR "functional device*" OR "fixed appliance*" OR "growth modif*" or brace* OR ((extraoral OR "extra oral" or extra‐oral) AND traction) OR "chin cap*" or chin‐cap* or chincap* OR "chin cup*" or chin‐cup* or chincup* or "face mask*" OR facemask* or face‐mask* OR "reverse head gear" OR "reverse head‐gear" OR ((orthopedic* OR orthopaedic*) AND (dental OR orthodontic* OR facial))))

Appendix 2. Cochrane Central Register of Controlled Trials (CENTRAL) search strategy

#1 MeSH descriptor Malocclusion, Angle Class III #2 ("Class III" in All Text and (Angle in All Text or Angle's in All Text or malocclusion* in All Text or bite* in All Text)) #3 (underbite* in All Text or under‐bite* in All Text or "under bite*" in All Text or "reverse bite*" in All Text or reverse‐bite* in All Text or prognath* in All Text)  #4 "prominent lower front teeth” #5 (#1 or #2 or #3 or #4) #6 MeSH descriptor Orthodontic Appliances, Functional explode all trees  #7 MeSH descriptor Orthodontic Appliances, Removable explode all trees #8 ("growth modif*" in All Text and (jaw in All Text or maxilla* in All Text or mandible in All Text)) #9 (("fixed appliance*" in All Text or brace* in All Text) and orthodontic* in All Text) #10 ((extraoral in All Text or extra‐oral in All Text or "extra oral" in All Text) and traction in All Text) #11 ("chin cap*" in All Text or chin‐cap* in All Text or chincap* in All Text) #12 (("face mask*" in All Text or face‐mask* in All Text or facemask* in All Text or "reverse head‐gear" in All Text or "reverse headgear" in All Text) and orthodontic* in All Text) #13 ((orthopedic* in All Text or orthopaedic* in All Text) and (dental in All Text or orthodontic* in All Text or facial in All Text)) #14 (#6 or #7 or #8 or #9 or #10 or #11 or #12 or #13)  #15 (#5 and #14)

Appendix 3. MEDLINE (Ovid) search strategy

1. Malocclusion, Angle Class III/  2. ("Class III" and (Angle or Angle's or malocclusion$ or bite$)).mp.  3. (underbite$ or under‐bite$ or "under bite$" or "reverse bite$" or reverse‐bite$ or prognath$).mp.  4. "prominent lower front teeth".mp.  5. or/1‐4  6. exp Orthodontic Appliances, Functional/  7. exp Orthodontic Appliances, Removable/  8. ("growth modif$" and (jaw or maxilla$ or mandible)).mp.  9. (("fixed appliance$" or brace$) and orthodontic$).mp.  10. ((extraoral or extra‐oral) and traction).mp. 11. "chin cap$".mp.  12. (("face mask$" or facemask$ or face‐mask$ or "reverse head‐gear" or "reverse headgear") and orthodontic$).mp. 13. ((orthopedic$ or orthopaedic$) and (dental or orthodontic$ or facial)).mp.  14. or/6‐13  15. 5 and 14

The above subject search was linked with the highly sensitive search strategy designed by Cochrane for identifying randomised controlled trials and controlled clinical trials in MEDLINE (as described in Lefebvre 2022, box 3c).

1. randomized controlled trial.pt. 2. controlled clinical trial.pt. 3. randomized.ab. 4. placebo.ab. 5. drug therapy.fs. 6. randomly.ab. 7. trial.ab. 8. groups.ab. 9. or/1‐8 10. exp animals/ not humans.sh. 11. 9 not 10

Appendix 4. Embase (Ovid) search strategy

1. Malocclusion/ 2. ("Class III" and (Angle or Angle's or malocclusion$ or bite$)).mp. 3. (underbite$ or under‐bite$ or "under bite$" or "reverse bite$" or reverse‐bite$ or prognath$).mp.  4. "prominent lower front teeth".mp.  5. or/1‐4  6. Orthodontic device/  7. ("growth modif$" and (jaw or maxilla$ or mandible)).mp.  8. (("fixed appliance$" or brace$) and orthodontic$).mp.  9. ((extraoral or "extra oral" or extra‐oral) and traction).mp.  10. ("chin cap$" or chin‐cap$ or chincap$).mp.  11. ((facemask$ or face‐mask$ or "face mask$" or "reverse headgear" or "reverse head‐gear") and orthodontic$).mp.  12. ((orthopedic$ or orthopaedic$) and (dental or orthodontic$ or facial)).mp. 13. or/6‐12  14. 5 and 13

Randomized controlled trial/
Controlled clinical study/
random$.ti,ab.
randomization/
intermethod comparison/
placebo.ti,ab.
(compare or compared or comparison).ti.
((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab.
(open adj label).ti,ab.
((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab.
double blind procedure/
parallel group$1.ti,ab.
(crossover or cross over).ti,ab.
((assign$ or match or matched or allocation) adj5 (alternate or group$1 or intervention$1 or patient$1 or subject$1 or participant$1)).ti,ab.
(assigned or allocated).ti,ab.
(controlled adj7 (study or design or trial)).ti,ab.
(volunteer or volunteers).ti,ab.
human experiment/
trial.ti.
or/1‐19
random$ adj sampl$ adj7 ("cross section$" or questionnaire$1 or survey$ or database$1)).ti,ab. not (comparative study/ or controlled study/ or randomi?ed controlled.ti,ab. or randomly assigned.ti,ab.)
Cross‐sectional study/ not (randomized controlled trial/ or controlled clinical study/ or controlled study/ or randomi?ed controlled.ti,ab. or control group$1.ti,ab.)
(((case adj control$) and random$) not randomi?ed controlled).ti,ab.
(Systematic review not (trial or study)).ti.
(nonrandom$ not random$).ti,ab.
"Random field$".ti,ab.
(random cluster adj3 sampl$).ti,ab.
(review.ab. and review.pt.) not trial.ti.
"we searched".ab. and (review.ti. or review.pt.)
"update review".ab.
(databases adj4 searched).ab.
(rat or rats or mouse or mice or swine or porcine or murine or sheep or lambs or pigs or piglets or rabbit or rabbits or cat or cats or dog or dogs or cattle or bovine or monkey or monkeys or trout or marmoset$1).ti. and animal experiment/
Animal experiment/ not (human experiment/ or human/)
or/21‐33
20 not 34

Appendix 5. US National Institutes of Health Ongoing Trials Register (clinicaltrials.gov)

orthodontic and “Class III”

orthodontic and “lower front teeth”

Appendix 6. World Health Organization International Clinical Trials Registry Platform

orthodontic and “Class III”

orthodontic and “lower front teeth”

Data and analyses

Comparison 1. Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Overjet	4	184	Mean Difference (IV, Random, 95% CI)	5.03 [3.81, 6.25]
1.1.1 Facemask	2	92	Mean Difference (IV, Random, 95% CI)	5.05 [3.19, 6.91]
1.1.2 Orthodontic removable traction appliance (ORTA)	1	40	Mean Difference (IV, Random, 95% CI)	6.20 [5.52, 6.88]
1.1.3 Tandem traction bow appliance (TTBA)	1	30	Mean Difference (IV, Random, 95% CI)	3.30 [2.46, 4.14]
1.1.4 Reverse Forsus	1	22	Mean Difference (IV, Random, 95% CI)	5.54 [4.40, 6.68]
1.2 ANB	8	345	Mean Difference (IV, Random, 95% CI)	3.05 [2.40, 3.71]
1.2.1 Facemask	5	184	Mean Difference (IV, Random, 95% CI)	3.60 [2.68, 4.52]
1.2.2 Chin cup	1	50	Mean Difference (IV, Random, 95% CI)	1.96 [1.58, 2.34]
1.2.3 Orthodontic removable traction appliance (ORTA)	1	40	Mean Difference (IV, Random, 95% CI)	3.81 [3.24, 4.38]
1.2.4 Tandem traction bow appliance	1	30	Mean Difference (IV, Random, 95% CI)	1.70 [1.09, 2.31]
1.2.5 Reverse Twin Block with lip pads and rapid maxillary expander	1	19	Mean Difference (IV, Random, 95% CI)	3.66 [2.73, 4.59]
1.2.6 Reverse Forsus	1	22	Mean Difference (IV, Random, 95% CI)	2.84 [1.89, 3.79]
1.3 Wits	4	175	Mean Difference (IV, Random, 95% CI)	4.75 [4.15, 5.35]
1.3.1 Facemask	2	65	Mean Difference (IV, Random, 95% CI)	3.58 [2.78, 4.37]
1.3.2 Chin cup	1	50	Mean Difference (IV, Random, 95% CI)	4.87 [4.53, 5.20]
1.3.3 ORTA (orthodontic removable traction appliance)	1	40	Mean Difference (IV, Random, 95% CI)	5.96 [4.71, 7.21]
1.3.4 Reverse Twin Block with lip pads and rapid maxillary expander	1	20	Mean Difference (IV, Random, 95% CI)	5.27 [4.04, 6.50]
1.4 Piers‐Harris self‐concept scale	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.4.1 15‐month follow‐up	1	69	Mean Difference (IV, Fixed, 95% CI)	1.50 [‐0.96, 3.96]

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Comparison 2. Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Overjet	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.1.2 3‐year follow‐up	1	63	Mean Difference (IV, Fixed, 95% CI)	2.50 [1.21, 3.79]
2.1.3 6‐year follow‐up	1	65	Mean Difference (IV, Fixed, 95% CI)	1.30 [‐0.16, 2.76]
2.2 ANB	1		Mean Difference (IV, Random, 95% CI)	Subtotals only
2.2.2 3‐year follow‐up	1	63	Mean Difference (IV, Random, 95% CI)	1.40 [0.43, 2.37]
2.2.3 6‐year follow‐up	1	65	Mean Difference (IV, Random, 95% CI)	0.70 [‐0.74, 2.14]
2.3 Piers‐Harris self‐concept scale	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.3.2 3‐year follow‐up	1	63	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐2.57, 3.77]
2.3.3 6‐year follow‐up	1	65	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐4.17, 3.57]
2.4 Oral Aesthetic Subjective Impact Score (OASIS)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.4.2 3‐year follow‐up	1	63	Mean Difference (IV, Fixed, 95% CI)	‐3.40 [‐7.99, 1.19]
2.4.3 6‐year follow‐up	1	65	Mean Difference (IV, Fixed, 95% CI)	‐2.20 [‐7.31, 2.91]
2.5 Need for surgery in adulthood (6‐year follow‐up)	1	65	Odds Ratio (IV, Fixed, 95% CI)	3.34 [1.21, 9.24]

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Comparison 3. Surgical orthodontic treatment versus untreated control.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Overjet	1	30	Mean Difference (IV, Fixed, 95% CI)	7.69 [6.99, 8.40]
3.1.1 With facemask	1	15	Mean Difference (IV, Fixed, 95% CI)	7.70 [6.78, 8.62]
3.1.2 With Class III elastics	1	15	Mean Difference (IV, Fixed, 95% CI)	7.68 [6.58, 8.78]
3.2 ANB	1	30	Mean Difference (IV, Fixed, 95% CI)	5.20 [4.48, 5.92]
3.2.1 With facemask	1	15	Mean Difference (IV, Fixed, 95% CI)	5.17 [4.04, 6.30]
3.2.2 With Class III elastics	1	15	Mean Difference (IV, Fixed, 95% CI)	5.22 [4.29, 6.15]

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Comparison 4. Facemask (RME) or modified facemask versus other non‐surgical appliance.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Overjet	4	136	Mean Difference (IV, Random, 95% CI)	0.96 [‐0.12, 2.04]
4.1.1 Mini maxillary protractor	1	32	Mean Difference (IV, Random, 95% CI)	‐0.06 [‐1.52, 1.40]
4.1.2 Pushing Splints	1	42	Mean Difference (IV, Random, 95% CI)	0.80 [‐0.37, 1.97]
4.1.3 Modified tandem appliance	1	32	Mean Difference (IV, Random, 95% CI)	2.28 [1.35, 3.21]
4.1.4 Reverse Forsus	1	30	Mean Difference (IV, Random, 95% CI)	0.46 [‐0.90, 1.82]
4.2 ANB	8	285	Mean Difference (IV, Random, 95% CI)	0.11 [‐0.54, 0.77]
4.2.1 Mini maxillary protractor	1	32	Mean Difference (IV, Random, 95% CI)	‐0.75 [‐1.49, ‐0.01]
4.2.2 Pushing Splints	1	42	Mean Difference (IV, Random, 95% CI)	1.40 [0.29, 2.51]
4.2.3 Modified tandem appliance	1	32	Mean Difference (IV, Random, 95% CI)	0.25 [‐0.39, 0.89]
4.2.4 Reverse Forsus	1	30	Mean Difference (IV, Random, 95% CI)	1.59 [0.80, 2.38]
4.2.5 Reverse Twin Block with lip pads and rapid maxillary expander	1	26	Mean Difference (IV, Random, 95% CI)	‐1.04 [‐2.07, ‐0.01]
4.2.6 Reverse chin cup	1	42	Mean Difference (IV, Random, 95% CI)	0.20 [‐0.71, 1.11]
4.2.7 Tongue plate appliance	1	47	Mean Difference (IV, Random, 95% CI)	‐0.60 [‐1.41, 0.21]
4.2.8 Frankel III functional appliance	1	34	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐1.29, 1.07]
4.3 Wits appraisal	3	102	Mean Difference (IV, Fixed, 95% CI)	‐0.00 [‐0.31, 0.30]
4.3.1 Reverse Twin Block with lip pads and rapid maxillary expander	1	26	Mean Difference (IV, Fixed, 95% CI)	‐1.85 [‐3.18, ‐0.52]
4.3.2 Frankel III functional appliance	1	34	Mean Difference (IV, Fixed, 95% CI)	0.06 [‐0.26, 0.38]
4.3.3 Pushing Splints	1	42	Mean Difference (IV, Fixed, 95% CI)	0.70 [‐0.60, 2.00]

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Comparison 5. Facemask (RME) or modified facemask versus surgically‐anchored appliance.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Overjet	1	43	Mean Difference (IV, Random, 95% CI)	‐0.40 [‐1.30, 0.50]
5.2 ANB	4	143	Mean Difference (IV, Random, 95% CI)	‐0.35 [‐0.78, 0.07]
5.2.1 Facemask (RME) versus facemask (miniscrew)	1	43	Mean Difference (IV, Random, 95% CI)	0.05 [‐0.99, 1.09]
5.2.2 Facemask (RME) versus upper removable appliance (URA) with miniscrews and Class III elastics	1	20	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.85, 0.65]
5.2.3 Facemask (RME) versus surgical miniplates (facemask)	1	41	Mean Difference (IV, Random, 95% CI)	‐0.45 [‐1.39, 0.49]
5.2.4 Facemask with transpalatal arch (TPA) versus facemask with TPA and miniscrew	1	39	Mean Difference (IV, Random, 95% CI)	‐0.80 [‐1.59, ‐0.01]
5.3 Wits	1	43	Mean Difference (IV, Fixed, 95% CI)	0.50 [‐1.27, 2.27]

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Comparison 6. Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Overjet	1	38	Mean Difference (IV, Fixed, 95% CI)	0.70 [0.25, 1.15]
6.1.1 Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR)	1	38	Mean Difference (IV, Fixed, 95% CI)	0.70 [0.25, 1.15]
6.2 ANB	1	38	Mean Difference (IV, Fixed, 95% CI)	1.77 [1.58, 1.96]
6.2.1 Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR)	1	38	Mean Difference (IV, Fixed, 95% CI)	1.77 [1.58, 1.96]

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Comparison 7. Facemask (RME) versus facemask only.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Overjet	1	31	Mean Difference (IV, Fixed, 95% CI)	1.86 [0.39, 3.33]
7.2 ANB	2	60	Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.94, 0.64]
7.3 Wits	2	60	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐1.08, 1.29]

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Comparison 8. Facemask (RME) versus facemask (Alt‐RAMEC).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
8.1 ANB	4	131	Mean Difference (IV, Random, 95% CI)	‐0.46 [‐1.03, 0.10]
8.2 Wits	3	97	Mean Difference (IV, Fixed, 95% CI)	‐0.38 [‐1.37, 0.60]
8.3 A‐NPerp	1	34	Mean Difference (IV, Fixed, 95% CI)	1.13 [0.23, 2.03]

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Comparison 9. Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
9.1 Overjet	1	30	Mean Difference (IV, Fixed, 95% CI)	0.22 [‐0.68, 1.12]
9.2 ANB	1	30	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐0.42, 1.22]
9.3 Wits	1	30	Mean Difference (IV, Fixed, 95% CI)	0.51 [‐0.69, 1.71]

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9.2 — Comparison 9: Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC), Outcome 2: ANB

Comparison 10. Facemask (RME) versus facemask (Nanda).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
10.1 ANB	1	20	Mean Difference (IV, Fixed, 95% CI)	1.29 [0.16, 2.42]

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Comparison 11. Chin cup (600 g) versus chin cup (300 g).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
11.1 ANB	1	40	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.31, 0.51]
11.2 Wits	1	40	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐1.12, 0.52]

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Comparison 12. Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
12.1 Overjet	1	35	Mean Difference (IV, Fixed, 95% CI)	0.91 [‐0.56, 2.38]
12.2 ANB	1	35	Mean Difference (IV, Fixed, 95% CI)	0.55 [‐0.40, 1.50]
12.3 Wits	1	35	Mean Difference (IV, Fixed, 95% CI)	0.28 [‐1.08, 1.64]

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Comparison 13. Surgical miniplates (facemask) versus surgical miniplates (Class III elastics).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
13.1 Overjet	1	20	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐1.23, 1.27]
13.2 ANB	1	20	Mean Difference (IV, Fixed, 95% CI)	‐0.05 [‐1.24, 1.14]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abdelnaby 2010.

*Study characteristics*
Methods	3‐arm parallel RCT
Participants	Number recruited: 50 (26 males and 24 females) Mean age: group 1: 9.6 years, group 2: 10.1 years, group 3: 9.2 years (range not given) Inclusion criteria: skeletal Class III (ANB < 1°) and mandibular prognathism (SNB > 80°) and an anterior crossbite. Assessed for skeletal maturation with hand‐wrist radiographs and shown to have not passed the peak of the pubertal growth spurt Exclusion criteria: not reported Setting: recruited from the Faculty of Dentistry, Mansoura University, Mansoura, Egypt
Interventions	Comparison:600 g chin cup versus 300 g chin cup versus untreated control Group 1 (n = 20): occipital pull soft chin cup (Dentaurum, Ispringen, Germany) with an acrylic occlusal bite plane of a thickness that just freed the occlusion anteriorly. Force applied was 600 g force per side. Participants were instructed to wear the appliance for 14 hours each day Group 2 (n = 20): as above using 300 g per side Group 3 (n = 10): no orthodontic or orthopaedic treatment
Outcomes	Outcomes relevant to the review: ANB, Wits appraisal All measures taken prior to treatment and after 1 year.
Notes	No sample size calculation was described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The method of randomisation was not described. Attempts were made to contact the authors for clarification but we did not receive a response. Study publication stated that participants were "randomly divided into three groups"; however, groups 1 and 2 have double the number of participants compared to group 3.
Allocation concealment (selection bias)	Unclear risk	The method of allocation concealment was not described. Attempts were made to contact the authors for clarification but we did not receive a response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not mentioned in the paper and blinding not possible. It is unclear how many clinicians provided the treatment.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	There was no mention of blinding of the assessor. Attempts were made to contact the authors for clarification but we did not receive a response. All radiographs were traced by a single operator.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was no mention of any loss of participants during the study. Attempts were made to contact the authors for clarification but we did not receive a response.
Selective reporting (reporting bias)	Low risk	All planned outcomes reported. Overjet was not an outcome in the study.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Alzabibi 2021.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 42 (40 analysed; 20 males and 20 females) Mean age: group 1: 8.95 years (0.88 SD), group 2: 9.14 years (0.80 SD) Inclusion criteria: skeletal Class III malocclusion caused by maxillary deficiency and/or mandibular prognathism (2 cephalometric conditions had to be met: −3° ≤ ANB ≤ 1.5° and −3 mm ≥ Wits appraisal ≥ −9 mm); an anterior crossbite or an edge‐to‐edge relationship; mixed dentition, age 8 to 10 years of age; good oral hygiene Exclusion criteria: previous orthodontic treatment; syndromes, clefts or craniofacial abnormalities; facial asymmetry; missing teeth or periodontal diseases Setting: Department of Orthodontics of the University of Damascus, Syria
Interventions	Comparison:orthodontic removable traction appliance (ORTA) versus untreated control Group 1: ORTA group (n = 21). The appliance consisted of 3 components: a lower thermoplastic retainer with a buccal button between each lateral incisor and canine (for attaching intermaxillary elastics); a banded Hyrax‐type rapid maxillary expander; and Class III elastics of 3/16‐inch diameter. The expansion screw was activated once per day for the first 7 days to disrupt the circum‐maxillary sutures in cases without posterior crossbites and over‐corrected if a crossbite was present. Participants were instructed to change elastics daily and wear the appliance at all times except when eating. All were treated until at least a 3 mm positive overjet was achieved, at which point they switched to nighttime‐only wear of the appliance for 2 to 3 months. Group 2: untreated control (n = 19). Participants in group 2 were left untreated and were observed for about 6 months. Their records were obtained at the beginning and the end of this period. Following local Research Ethics Committee guidelines, these participants were treated by postgraduate students immediately after the end of the observation period.
Outcomes	Outcomes relevant to the review: overjet, ANB and Wits Lateral cephalograms of each participant were obtained at the beginning and end of the treatment period (mean 4.34 months (SD 2.02)) or observation period (mean 6 months). All radiographs were taken with maximum intercuspation, relaxed lips and a natural head position.
Notes	The authors described a sample size calculation.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"42 participants were randomly chosen, and then assigned randomly to the 2 study groups using a computer‐generated list of random numbers with a 1:1 allocation ratio (21 in each group)."
Allocation concealment (selection bias)	Low risk	"The assigned group for each participant was concealed using opaque sealed envelopes that were not opened until the patient sorting was started."
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Due to the nature of the trial, blinding of the participants and the clinicians was not applicable."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"...all cephalometric radiographs were coded. This ensured that the measurements were carried out by 1 assessor who was totally blinded to the study group..."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropout rates: 4.8% all; 0% ORTA; 9.5% control group "Two participants in the control group dropped out of the study for personal reasons. Therefore, 40 were included in the statistical analyses."
Selective reporting (reporting bias)	Low risk	All planned outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Arun 1994.

*Study characteristics*
Methods	3‐arm parallel RCT
Participants	Number recruited: 60 (26 males and 34 females) Mean age: group 1: 8.26 (0.4 SD), group 2: 8.19 years (0.3 SD), group 3: 8.24 years (0.4 SD), (range 7.44 to 8.97 years) Inclusion criteria: ANB < 2.5°, Jarabak ratio greater than 59%, antegonial notch depth less than 2 mm Exclusion criteria: not reported Setting: treated in the Marmara University Dental Faculty, Turkey
Interventions	Comparison:mandibular headgear versus chin cup versus untreated control Group 1 (n = 20): mandibular headgear group: prefabricated tubeless bands were thoroughly adapted to the lower molar teeth. They were then removed from the mouth and orthobuccal tubes were spot welded in the middle of their buccal surfaces. The bands were seated back on the molar teeth and a facebow, with downward facing U bends of its inner bow, was inserted into the tubes. The desired force was applied to the facebow. The bands were cemented and the participants instructed to use their appliance 24 hours later. The outer bow was initially positioned parallel to the inner bow. Later, its arms were bent downwards in the parallel position. Group 2 (n = 20): chin cup group: force directed obliquely on a line from the symphysis to the condyle. The head straps of the chin cup passed 1 cm above the earlaps in the temporal region and enwrapped the cranial vault. Topical application of the talcum powder was recommended in case the metal connections of the chin cup caused allergic reactions. In both treatment groups, the first review was 1 week after the insertion of the appliance and thereafter at 3‐week intervals. Both groups were advised to use the appliances 16 hours per day during the 1‐year treatment period. Forces were maintained at 480 to 500 g in both groups. The effects of any anterior crossbite were eliminated and the mandibular distal movement freed from occlusal interferences through application of posterior bite planes. Group 3 (n = 20): no treatment
Outcomes	Outcomes relevant to this review: ANB Open and closed mouth lateral cephalograms were taken of all 60 participants at the beginning and end of the 12‐month treatment and control period. The condylion point was first traced on the open‐mouth lateral cephalogram then, using its mandibular projection as a guide, it was superimposed on the closed‐mouth lateral cephalogram on which 18 cephalometric points were selected for analysis.
Notes	A sample size calculation was not described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Contact from author confirmed that a random number generator was used for participant assignment on registration to the study.
Allocation concealment (selection bias)	High risk	Contact from author confirmed that no allocation concealment was used.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, blinding of participants was not possible. It was unclear how many treating clinicians were involved and all radiographs were traced by one operator.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Contact from author confirmed that there was no blinding of any assessors during the study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the study and were included in the analysis.
Selective reporting (reporting bias)	Low risk	All planned outcomes were reported, but these did not include overjet.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Atalay 2010.

*Study characteristics*
Methods	3‐arm parallel RCT (2 relevant arms)
Participants	Number recruited: 30 in the two relevant arms (16 males and 14 females) Mean age: group 1: 8.18 years (0.5 SD), group 2: 7.9 years (0.62 SD) Inclusion criteria: skeletal Class III (ANB < 0°), due to maxillary retrusion, or a combination of maxillary retrusion and mandibular protrusion. Angle Class III malocclusion with an anterior crossbite. An optimum SN/GoGn angle (between 26° and 38°). Fully erupted maxillary incisors Exclusion criteria: congenitally missing teeth or congenital syndromes such as a cleft lip/palate. Previous orthodontic treatment Setting: recruited from Gazi University, Turkey
Interventions	Comparison:tandem traction bow appliance (TTBA) versus untreated control Group 1 (n = 15): modified TTBA: comprised an upper splint, lower splint and modified conventional headgear facebow (traction bow). The upper splint was retained by Adams' clasps in the posterior region for retention and elastic hooks between the maxillary central and lateral incisors. The upper splint covered the palatal and occlusal surfaces, in addition to 1 to 2 mm of the buccal surfaces of the maxillary teeth. The lower splint covered the buccal and lingual surfaces of the mandibular teeth. Activator tubes were embedded in the posterior region of the lower splint. Elastics that exerted a force of 400 to 500 g on 1 side were worn between the labial hooks and the traction bow. The elastic force was directed between 35° and 40° to the occlusal plane by arranging the position of the outer traction bows. The children were instructed to wear the appliance approximately 14 to 16 hours a day. The mean treatment time was 9 months. Group 2 (n = 15): control group: observed without treatment for 8 months
Outcomes	Outcomes relevant to this review: overjet, ANB Lateral cephalometric radiographs were taken before treatment and after a Class I molar relationship and a minimum overjet of 2 mm was obtained. Pre‐ and post‐treatment lateral cephalograms were traced by hand and measured by 1 author. 21 parameters were evaluated.
Notes	A sample size calculation was not described. Investigators set up the study with the 'no treatment' group as a control group for the early treatment group. We did not use the participant group assessing late treatment, which was made up of 15 participants of mean age 11.75 years.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Contact from author confirms that random sequence generator using patient application numbers was used.
Allocation concealment (selection bias)	High risk	Contact from author confirms that no allocation concealment was used.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, blinding of participants was not possible. It was unclear how many clinicians provided the treatment.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Contact from author confirms that no blinding of assessors was used.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the study and were accounted for in the analysis.
Selective reporting (reporting bias)	Low risk	All cephalometric measurements were recorded and analysed.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Canturk 2015.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 36 (30 analysed; 14 males and 16 females) Mean age: group 1: 11.27 years (1.26 SD), group 2: 10.53 years (1.50 SD) Inclusion criteria: skeletal Class III malocclusion (ANB angle < 0°) and negative overjet; vertically normal growth pattern (SN–GoMe 32° ± 6); no signs of functional Class III malocclusion; early stages of cervical vertebral maturation detected using the Lamparski method; no history of temporomandibular disorders, congenital deformities, or previous orthodontic treatment Exclusion criteria: not stated Setting: recruited from the Department of Orthodontics, Faculty of Dentistry, Karadeniz Technical University, Trabzon, Turkey
Interventions	Comparison:facemask after alternating expansion and constriction (Alt‐RAMEC) versus facemask startedsimultaneously with Alt‐RAMEC Group 1 (n = 15): maxillary protraction after alternating rapid maxillary expansion and constriction Group 2 (n = 15): maxillary protraction started simultaneously with alternating rapid maxillary expansion and constriction The screw of the RME appliance was alternately activated and deactivated twice daily (0.20 mm per turn) for 1 week over the course of 8 weeks. After the Alt‐RAMEC procedure was completed, the activation of the screw was continued until the crossbite was overcorrected for the children with posterior crossbite (2 in Group 1), and it was activated for 1 week for the children without crossbite (13 in Group 1 and 15 in Group 2). In both groups, a Petit‐type facemask was used and a maxillary protraction force of 500 g per side with an anteroinferior force vector of approximately 30° to the occlusal plane was applied from the hooks placed in the canine region on the buccal sides of the expanders. The children were instructed to wear the appliances for at least 20 hours per day until at least a 2 mm positive overjet was achieved, and the parents were asked to replace the elastics at least once a day and to record the daily use of the appliances.
Outcomes	Outcomes relevant to the review: overjet, ANB and Wits Standardised lateral cephalograms taken by an experienced technician at beginning (T1) and end (T2) of facemask treatment using the same cephalostat (Siemens Nanodor 2, Siemens AG, Munich, Germany).
Notes	The authors described a sample size calculation.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	36 participants were divided into 2 groups using a randomisation method with pitch and toss.
Allocation concealment (selection bias)	Unclear risk	Unclear who performed the randomisation process.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. All participants were treated by the same clinician.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	After the calibration was done, all radiographs were traced by one researcher with a random queue of the cephalometric films; the researcher did not know to which group the participant belonged in order that the assessment was made blind. Attempts were made to clarify with the authors if the RME appliance was removed before the T2 radiograph was taken, but we did not receive a response.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Three patients in each group discontinued the treatment, and ultimately 15 patients in each group were analyzed". No reasons for discontinuation given
Selective reporting (reporting bias)	Low risk	All expected outcomes reported
Other bias	Low risk	The study appears to be free of other sources of bias.

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Celikoglu 2015.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 34 (32 analysed; 13 males and 19 females) Mean age: group 1: 12.00 years (0.89 SD), group 2: 11.51 years (0.66 SD) Inclusion criteria: skeletal class III malocclusion (ANB angle < 0°) and negative overjet; vertically normal growth pattern (SN–GoMe 32° ± 5); late mixed or early permanent dentition; no signs of functional class III malocclusion determined after clinical examination; no history of temporomandibular disorders; no systemic diseases or congenital deformities; no previous orthodontic treatment Exclusion criteria: not reported Setting: recruited from Department of Orthodontics, Faculty of Dentistry, Ataturk University, Turkey
Interventions	Comparison:facemask versus mini maxillary protractor Group 1: facemask group (n = 16). Four‐banded RME appliance (Hyrax type) used for expansion and Petit‐type facemask for maxillary protraction Group 2: mini maxillary protractor (n = 16). The appliance consisted of intra‐ and extra‐oral parts. The maxillary part was a full‐coverage acrylic splint type maxillary expander with two hooks extended to the canine eminence. The mandibular part was composed of an acrylic plate covering all posterior teeth and a chin cup, which were connected to each other by a special bow. The bow was bent from 1.2 mm stainless steel round arch wire, and a horizontal bar was soldered on it to apply protraction forces from the hooks on the maxillary expander. The extra‐oral part of the appliance was cervical headgear. In both groups, the screw was activated twice a day, even in the absence of a posterior crossbite. Participants with posterior crossbites were over‐corrected and maxillary suture was opened (determined by means of occlusal film). A maxillary protraction force of 400 to 500 g per side with a downards and forwards vector of approximately 30° to the occlusal plane was applied from the hooks placed in the canine region on the buccal sides of the expanders in both groups. The participants in both groups were instructed to wear the appliances for at least 20 hours per day until a 2 mm positive overjet was achieved.
Outcomes	Outcomes relevant to the review: overjet, ANB Cephalometric films were taken in a standard position in the same cephalostat (Siemens Nanodor 2, Siemens AG, Munich, Germany) by an experienced technician within 2 weeks prior to protraction therapy (T1) and within a week after protraction therapy was completed (T2) in both groups.
Notes	The authors described a sample size calculation.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	34 children who met the study inclusion criteria were randomly divided into 2 groups using a random number table.
Allocation concealment (selection bias)	Unclear risk	Not declared
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. The participants were treated by 2 clinicians.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not declared. Attempts were made to clarify with the authors if the RME appliance was removed before the T2 radiograph was taken, but we did not receive a response.
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 participant in each group discontinued the treatment.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Chen 2012.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 20 (9 males and 11 females) Mean age: group A: 11.8 years (1.6 SD); group B: 12.1 years (1.4 SD) Inclusion criteria: cephalometric film showed the skeletal Class III malocclusion was dominated by maxillary hypoplasia, with ANB < 0°, anterior crossbite, and when the mandible was in the retruded contact position, the anterior teeth could not reach the edge‐to‐edge bite; the x‐ray of the left wrist bone indicated the child was still in the growth peak; no cleft lip or palate, or any other maxillofacial deformities; no orthodontic histories Exclusion criteria: none declared Setting: Department of Stomatology, Fengcheng Hospital, Fengxian District, Shanghai
Interventions	Comparison: single rapid maxillary expansion followed by facemask versus repetitive rapid maxillary expansion and constriction followed by facemask Group A: single rapid maxillary expansion followed by maxillary protraction (n = 10). After the appliance was fitted, 1 week of rapid maxillary expansion was commenced by turning the Hyrax screw twice a day equating to a quarter turn each time, followed by maxillary protraction for 5 months and 3 weeks. Group B: repetitive rapid maxillary expansion and constriction followed by maxillary protraction (n = 10). After the appliance was fitted, 1 week of rapid maxillary expansion was commenced by turning the Hyrax screw twice a day, equating to a quarter turn each time. In the second week, group B participants received constriction (after turning in the opposite direction) twice a day, equating to a quarter turn each time. Participants then switched between expansion and retraction until the 5th week, and received maxillary protraction for 4 months and 3 weeks afterwards. Both groups had a Hyrax appliance consisting of bands on the maxillary first premolars and maxillary first molars and towing hooks. Furthermore, both groups used protraction facemask reverse headgear with double bars. The traction on both sides was 500 g for at least 14 hours per day. The traction direction was 15° to 30° forward and downward from the occlusal plane.
Outcomes	Outcomes relevant to the review: ANB, Wits Standard cephalometric films were taken and analysed at baseline and after half a year.
Notes	There was no indication of a sample size calculation. The original article was translated from Chinese to obtain relevant information. Authors were contacted for further information but did not respond.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The children were randomly divided into 2 groups but it was unclear exactly how this was performed.
Allocation concealment (selection bias)	Unclear risk	It was unclear how allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It was unclear how the assessors were blinded to the source of the films or if the RME appliances were removed prior to the T2 radiograph.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	It is unclear if there were any dropouts.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Elnagar 2016.

*Study characteristics*
Methods	3‐arm parallel RCT
Participants	Number recruited: 30 (20 males and 10 females) Mean age: group 1: 11.92 years (1.29 SD), group 2: 12.24 years (1.08 SD), group 3: 11.67 years (1.64 SD) Inclusion criteria: growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method; skeletal Class III malocclusion with maxillary deficiency (ANB ≤ 0°; Nperp‐A < 0°) with or without mandibular prognathism; late mixed or early permanent dentition at the start of treatment characterised by a Wits appraisal of 1 mm or less and an Angle Class III molar relationship or anterior crossbite; vertically normal growth pattern determined by cephalometric x‐rays; no cleft and other craniofacial anomaly; no previous orthodontic treatment Exclusion criteria: not reported Setting: conducted in the orthodontic departments of 2 universities: Tanta University, Tanta, Egypt, and University of Illinois, Chicago, USA
Interventions	Comparison:facemask with miniplates versus miniplates with Class III elastics versus untreated control Group 1: facemask and miniplates (n = 10). A mucoperiosteal flap was raised and a surgical miniplate was bent to shape according to the anatomy of the zygomatic buttress and fixed with 3 self‐tapping bone screws per side. The end of the miniplate was left exposed over the keratinised attached gingiva near the canine and the last hole of the miniplate was cut to create a hook for the elastics. A facemask was used with an orthopaedic force of at least 400 to 500 g per side directed 30° downward and forward from the occlusal plane was applied by heavy extraoral elastics (Ormco, Orange, California). The children were instructed to wear the appliance for at least 14 to 16 hours per day and to change the elastics daily. Group 2: miniplates and class III elastics (n = 10). Four straight miniplates were placed in each child's mouth at the infrazygomatic crest of the maxillary buttress and in the mandible between, and inferior to, the left and right permanent lateral incisors and canines. In the maxilla, "L‐shaped" mucoperiosteal flaps were raised mesial to the zygomatic crest and the plates were bent freehand in order to follow the cortical anatomy. In the mandible, inverted "L‐shaped" mucoperiosteal flaps were raised and straight miniplates were bent freehandedly to adapt to the bone inferiorly between the mandibular lateral incisors and canines. At all sites, the plates were fixed with 2 to 3 self‐tapping bone screws per side. The ends of the miniplates were exposed over the keratinised attached gingiva to prevent gingival irritation, and the distal end holes of the miniplates were cut to create a hook for the elastics. Elastics were placed on each side to give vectors of force downward and forward for the maxilla, and backward and upward (closing rotation) for the mandible. The elastics were chosen to provide a force of approximately 250 g to each side. The children were instructed to wear the elastics 24 hours per day. The elastics were replaced at least once a day. Group 3: untreated control (n = 10) In both groups receiving active treatment, a removable biteplate covering the occlusal surface of maxillary teeth was placed to eliminate occlusal interference in the incisor region until correction of the anterior crossbite was obtained. All elastic and protraction forces were measured by a force gauge (Correx Tension Gauge; Haag‐Streit Diagnostics, Koeniz, Switzerland). Oral hygiene instructions were reiterated with particular emphasis on brushing the tissues around the miniplates with a soft toothbrush. The decision to discontinue orthopaedic treatment in both groups was made by the operator when the children had 3 to 4 mm of positive anterior overjet.
Outcomes	Outcomes relevant to the review: overjet, ANB Cephalometric radiographs were obtained before and after the maxillary protraction or observation periods in all groups.
Notes	A sample size calculation was not described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were divided using random number tables into 3 groups.
Allocation concealment (selection bias)	Low risk	This was clarified with the author. The numbers were sealed in opaque envelopes and shuffled by a staff member. A clinical assistant opened an envelope for the group assignment after clinical examination and eligibility to participate in the study.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. All participants were treated by the same clinician.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The removal of the miniplates prior to assessing cephalometric treatment changes was confirmed with the author.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts, confirmed with author
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Galeotti 2021.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 48 (42 analysed; 21 males and 21 females) Mean age: group 1: 7.00 years (1.20 SD), group 2: 7.20 years (1.30 SD) Inclusion criteria: Caucasian ethnicity (understood to be white); deciduous, early or late mixed dentition; aged between 4 and 10 years old; mesial step deciduous molar relationship or Class III permanent molar relationship in centric position; pre‐treatment Wits appraisal of −2.0 mm or less Exclusion criteria: functional shift in occlusion; craniofacial anomalies; systemic disease affecting normal growth patterns; clinically evident (more than 5%) facial and/or mandibular asymmetry; previous orthodontic treatment; impacted teeth; anomalies in dental morphology; periodontal disease; signs and symptoms of temporomandibular disorders Setting: Dentistry Unit of Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy Ethnicity: white ethnicity was part of the inclusion criteria
Interventions	Comparison:Pushing Splints 3 (PS3) appliance versus facemask Group 1: pushing splints 3 (n = 21). The appliance consisted of three components: two removable acrylic splints and one Forsus L‐pin module per side. The two splints covered all the tooth crowns in both arches. The Forsus modules were used to deliver a force of 200 g per side in a forward direction to the upper splint and in a backward direction to the lower splint. The coil springs were re‐activated when necessary so that they would always be compressed. No expansion of the upper arch was performed. Group 2: facemask and bonded rapid maxillary expander (RME) with hooks for the facemask (n = 21). One‐quarter activation of the screw was performed once a day until the palatal cusps of the upper molars approximated the buccal cusps of the mandibular molars even if no posterior crossbite existed. The participants were instructed to wear the facemask using elastics connected downwards at 30° from the vestibular hooks on the RME to the facemask for 14 hours a day. Extraoral 3/8 8 oz elastics (one for each side) were prescribed for 10 days, after which the force was increased to 350 to 400 g for each side using 5/16 14 oz elastics.
Outcomes	Outcomes relevant to the review: overjet, ANPog, Wits Both groups performed lateral cephalograms before and at the end of treatment. The authors reported on harms. This was limited to breakages and participants encountering difficulties in maintaining good oral hygiene levels. The use of facemask rarely created decubitus on the chin. When this occurred, temporary suspension and application of an ointment with Vitamin E was advised.
Notes	The authors performed a sample size calculation.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The children were randomly allocated to two groups. The randomisation list was generated in randomisation blocks of 10 with stratification by gender.
Allocation concealment (selection bias)	Low risk	The numbers were sealed in opaque envelopes and the children were randomly allocated into two groups. One operator was responsible for opening the next envelope in sequence and implementing the randomisation process.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Lateral cephalograms were taken without the appliance. The cephalograms were labelled with numbers and randomly assessed by researchers who knew neither the time point nor the treatment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 from each group (3 males, 3 females, mean age 7.70 years ± 1.5 SD) were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Ge 2012.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 49 (43 analysed; 20 male, 23 female) Mean age: group 1: 10 years 4 months, group 2: 10 years 6 months Inclusion criteria: skeletal and dental Class III malocclusion with maxillary deficiency (ANB < 0°); Wits appraisal < ‐2 mm); reverse incisor relationship and positive overbite; no significant skeletal asymmetry; no systemic diseases or congenital deformities Exclusion criteria: not reported Setting: ShenZhen Children’s Hospital, ShenZhen, China Ethnicity: article stated that participants were of Chinese ethnicity
Interventions	Comparison: miniscrew implant with facemask versus rapid maxillary expander with facemask Group 1 (n = 20): a mucoperiosteal flap was elevated above the maxillary first molar and a miniscrew of 2 mm diameter and 14 mm length was inserted at an angle of 55° to 70° to the maxillary occlusal plane under local anaesthesia in the zygomatic buttress. The head of the miniscrews remained outside the mucogingival junction so that elastics could be attached. Miniscrews were left for 2 weeks before loading and a Petit facemask was subsequently fitted with the application of 200 g to 250 g force to the miniscrews on each side at a 30° angle downward to the occlusal plane. The children were instructed to wear the facemasks for at least 14 hours per day. Group 2 (n = 23): a bonded maxillary expander (Hyrax, Leone, Florence, Italy) was placed and participants were instructed to activate the expander twice a day with a quarter turn (0.5 mm/d) until the desired transverse width was achieved. Participants were given a Petit facemask simultaneously and elastics were attached from expander hooks to the facemask in a downward and forward vector, producing orthopaedic forces of 400 g to 500 g per side. Treatment was continued until positive dental overjet was achieved.
Outcomes	Outcomes relevant to this review: overjet, ANB, Wits appraisal Standardised lateral cephalograms of each participant taken at beginning and end of treatment. All radiographs taken with same cephalometer.
Notes	A sample size calculation was not described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The method of randomisation was not described. We attempted to contact the authors for clarification but we did not receive a response.
Allocation concealment (selection bias)	Unclear risk	The method of allocation concealment was not described. We attempted to contact the authors for clarification but we did not receive a response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	There was no mention of blinding of the assessor. We attempted to contact the authors for clarification but we did not receive a response.
Incomplete outcome data (attrition bias) All outcomes	High risk	20% of the sample was lost from the miniscrew implant with facemaskgroup. "During treatment, four subjects of the initial MSI/FM group were excluded because of the mobility of miniscrews, and one subject of each group was excluded because of poor cooperation."
Selective reporting (reporting bias)	Low risk	All outcomes that were planned were adequately reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Husson 2016.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 32 (15 males and 17 females) Mean age: group 1: 7.98 years (0.68 SD), group 2: 8.11 years (0.76 SD) Inclusion criteria: early mixed dentition; class III molar relationship; anterior crossbite or edge‐to‐edge incisal relationship; ANB angle of 0° or less; A‐point to the perpendicular on FH from Nasion of 1 mm or less; no extracted or congenitally missing teeth; no deformity in the nasomaxillary complex; normal or horizontal growth pattern (Bjork's sum = 396° +/‐ 5°); no history of temporomandibular disorders Exclusion criteria: not mentioned Setting: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syrian Arab Republic
Interventions	Comparison:modified tandem appliance versus facemask Group 1: modified tandem appliance (MTA) (n = 16). The appliance was composed of three components; two fixed and one removable. The upper component was composed of a bonded maxillary expander, with 2 mm posterior acrylic splint to release upper dentition from occlusion and buccal arms distal to the lateral incisors for elastic traction. The lower appliance was composed of fixed buccal lingual arches with buccal headgear tubes. A headgear facebow with the outer bows bent out for elastic attachment was inserted into the lower tubes. Group 2: facemask (n = 16); this was composed of the same bonded expander as group 1 and a Petit‐type facemask. A unified method of expansion and elastic traction was used in both groups. The screw of the maxillary expander was activated twice a day until palatal suture was opened in cases without posterior crossbite and over‐corrected in cases with posterior crossbite. The initial protraction force of 230 g per side was applied with an anterointerior force vector of approximately 30° to the occlusal plane for 6 weeks, and increased to 400 g until a 2 mm positive overjet was achieved. In both groups, children were instructed to wear their appliances at least 16 hours per day.
Outcomes	Outcomes relevant to the review: overjet, ANB Lateral cephalometric radiographs were taken using the same X‐ray machine (Planmeca; Planmeca Oy, Helsinki, Finland) at the beginning of the treatment and after obtaining an adequate overjet of 2 mm. All radiographs were taken in a standard patients' position in the cephalostat ‐ teeth in occlusion and lips relaxed. Mean treatment times: 7.07 months (SD 0.78) in group 1; 6.4 months (SD 1.3) in group 2
Notes	The authors performed a sample size calculation.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Children who met the inclusion criteria were randomised in a 1:1 ratio into two equal groups using an online randomisation service (www.randomizer.org).
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The group to which each participant belonged was unknown when the radiographs were traced and measured.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No participants were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Jamilian 2011.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 20 (8 males and 12 females) Mean age: group 1: 10.5 years (1.5 SD), group 2: 11.3 years (0.8 SD) Inclusion criteria: skeletal Class III (ANB < 0°), maxillary hypoplasia (SNA < 80°), mandibular prognathism (SNB > 80°) and Class III molar relationship with concave profile Exclusion criteria: not reported Setting: private orthodontic clinic, Tehran, Iran
Interventions	Comparison: facemask and upper removable appliance (URA) versus URA with mini‐screw and Class III traction Group 1 (n = 10): uni‐bar facemask and URA with two hooks on the upper molars, which were connected by two elastics (5/16 medium size) to the facemask. Group 2 (n = 10): URA with Adams clasps on the upper first permanent molars and premolars. C clasps on the upper permanent canines and central incisors. If needed, more C clasps and Adams clasps were added for better anchorage. Miniscrews were connected to the Adams clasps of the URA by orthodontic latex elastics (5/16 medium size) in order to generate approximately 350g of anterior retraction. Both groups: participants were instructed to wear the appliances full‐time except for eating, contact sports and tooth brushing. In order to retain these elastics, the Adams clasps on the molars were bent to form two loops. An expansion screw was placed in the midpalatal area of the URA and the participants were instructed to turn the screw once a week in order to correct the posterior crossbites.
Outcomes	Outcomes relevant to the review: ANB Measured pre‐ and post‐treatment. Treatment lasted an average of 11 months for miniscrew treatment and 13 months for facemask treatment.
Notes	We contacted the trial author by email and he confirmed the information relating to the study having a low risk of selection bias and attrition bias.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Allocation by coin flip. The coin was flipped after they recruited the participants.
Allocation concealment (selection bias)	Low risk	The coin was flipped after they recruited the participants.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. Treatment was carried out by one clinician in a private clinic setting.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The assessor was blind to the intervention and stage of treatment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No participants were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All planned outcomes reported, but overjet was not an outcome in the study.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Keles 2002.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 20 (10 males and 10 females) Mean age: group 1: 8.51 years, group 2: 8.58 years (range 7.3 to 10.9) Inclusion criteria: healthy patients without any hormonal or growth discrepancy. Anterior crossbite with Class III molar relationship. True Class III patients. Class III patients with maxillary retrognathism Exclusion criteria: pseudo or functional Class III Setting: recruited from Marmara University, Istanbul, Turkey
Interventions	Comparison:Nanda facemask versus conventional facemask Group 1 (n = 11): facemask with modified angle of force direction (Nanda): composed of 3 parts ‐ a modified full‐cover acrylic cap splint expansion appliance, a specially designed facebow and a Petit type protraction headgear. The cap splint expansion appliance was modified by adding 2 tubes (3M Unitek, USA) on the buccal side of the acrylic in the premolar area. The tubes were soldered to the RME screw (Leone) and the acrylic was constructed. The purpose of these tubes was to accommodate the inner bows of the specially designed facebow. The facebow was constructed from an adjustable facebow (Ormco, Glendora, CA, USA). The inner bows of the facebow ended in the mouth with a special U‐shaped bend in order to enter the buccal tubes from the distal, and thus be able to retain itself when an anterior pull was applied. In order to carry the level of force application above the occlusal plane, the outer bows of the facebow were bent in a 30° upward direction and ended with 2 hook bends in order to hold the elastics used for the facemask. These hooks were positioned around the root tips of the first and second premolars and 500 g of force was applied parallel to the Frankfort plane in an anterior direction. The same Petit‐type facemask was used and the direction of the force was adjusted by moving the wire piece upward on the facemask for elastic engagement. Group 2 (n = 9): conventional facemask: consisted of a cap splint–type rapid palatal expander modified by adding 2 hooks in the canine area. The purpose of these hooks was to hold the elastics in place for protraction. The protraction headgear was a Petit type (Ormco Corporation, Glendore, California), and a force of 500 g was applied to each hook at a 30° angle to the occlusal plane. In both groups, treatment started with 10 days of rapid maxillary expansion. Following the expansion, a facemask was applied to the patients of both groups and the appliance was used for 6 months after the onset of treatment. Patients were advised to wear the facemask for a minimum of 16 hours per day in the first 3 months and 12 hours in the second 3 months. In both groups, a 500 g force was used. In group 1, the force was applied parallel to the Frankfort horizontal plane; in group 2 it was angled downward 30° to the occlusal plane.
Outcomes	Outcomes relevant to this review: ANB Lateral cephalometric films were taken both at the beginning and the end of treatment (6 months). 18 linear and angular cephalometric measurements were made for all participants.
Notes	A sample size calculation was not described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The method of sequence generation was not described. We attempted to contact the authors for clarification but we have not yet received a response.
Allocation concealment (selection bias)	Unclear risk	The method of allocation concealment was not described. We attempted to contact the authors for clarification but we have not yet received a response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. There was no reliability or repeatability testing undertaken.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	There was no mention of blinding of the assessor. We attempted to contact the authors for clarification but we have not yet received a response.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was no mention of any loss of participants during the study. We attempted to contact the authors for clarification but we have not yet received a response.
Selective reporting (reporting bias)	Low risk	All planned outcomes reported, but overjet was not an outcome in the study.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Liang 2021.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 41 (19 males and 21 females) Mean age: group 1: 10.75 years (1.3 SD), group 2: 10.5 years (1.1 SD) Inclusion criteria: maxillary deficiency (distance from point A to nasion perpendicular < 0 mm) and skeletal Class III malocclusion; an Angle Class III occlusal relationship with an anterior crossbite; a concave lateral profile with midface deficiency; and prepubescent stage of skeletal age, as verified by the hand‐wrist radiographs Exclusion criteria: prior orthodontic or orthopaedic treatment; other craniofacial anomalies or syndromes; and "poor compliance of patient (patients who declared disagreement with the cooperation degree required for this treatment)" Setting: Department of Orthodontics, School of Stomatology, Capital Medical University, Beijing, China Ethnicity: article stated that participants were of Chinese ethnicity
Interventions	Comparison:surgical miniplates (facemask) versus facemask (RME) Group 1: surgical miniplate group (n = 20). Two customised miniplates were implanted in the anterior segment of the maxilla, one on each side, for each participant. The customised, 3D‐printed miniplates (Concept Laser GmbH, Lichtenfels, Bavaria, Germany) were inserted in the maxilla using guidance templates and under local anaesthesia. Each miniplate was fixed to the bone with 2 or 3 titanium mini‐screws (1.2 to 2.0 mm in diameter, 4 to 6 mm in length; Synthes, Zuchwil, Switzerland). Four weeks after insertion, traction forces were applied to the miniplates. At the end of the treatment period, the miniplates were removed under local anaesthesia. Group 2: facemask (RME) group (n = 21). The RME appliance was bonded on the maxillary first molars and first premolars or deciduous first molars. Two hooks, above maxillary canines on each side, were soldered to the RME appliance to receive elastics for protraction. Both groups: before maxillary protraction, all participants underwent RME to disrupt midpalatal suture. The RME appliance was expanded twice per day (0.25 mm per turn) until the posterior buccal crossbite had been achieved. The traction forces were applied to each group on the day after RME, and the RME appliance was retained for 6 months to keep the expanded space. 400 g to 500 g of elastic traction was applied to each side for all participants. The force was applied at 30° below the occlusal plane to minimise the maxillary counter‐clockwise rotation. The elastic traction was worn for at least 14 hours per day. Maxillary protraction was stopped when Class III molar relationship and the anterior crossbite were over‐corrected.
Outcomes	Outcomes relevant to the review: ANB Pre‐treatment (T1) and post‐treatment (T2) CBCT scans were taken with standardised parameters.
Notes	A sample size calculation was not described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The participants were randomly divided into 2 groups. Exact randomisation method was not declared and was not clarified by the author (YB): "Participants were randomly divided into two groups."
Allocation concealment (selection bias)	High risk	Not stated. This was clarified by the author (YB), but there may have been confusion between the terms concealment and blinding: "The treatment plan of two groups were different, so the random allocation was not concealed."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the study it was not possible to blind. All participants were treated by the same 2 clinicians.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details of blinding and not confirmed by the author (YB). CBCT would not have shown the appliance used but participants could be recognisable to the one operator assessing the T1 and T2 scans.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Not stated and no CONSORT diagram provided. Confirmation from the author (YB) reported that there were no dropouts: "No participant was lost."
Selective reporting (reporting bias)	Low risk	All planned outcomes reported, but overjet was not an outcome.
Other bias	Low risk	Confirmation from the author (YB) that a repeatability study for the CBCT images was undertaken despite not being reported: "Yes, we have repeatability study for CBCT measurements."

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Liu 2013.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 34 (18 males and 16 females) Mean age: group A: 9.78 years (1.69 SD), group B: 10.23 years (1.50 SD) Inclusion criteria: aged 7 to 13 years, in mixed or early permanent dentition with first maxillary molar erupted; with retrognathic maxilla, Class III malocclusion, anterior crossbite, condition of the maxillary dentition suitable for appliance placement; ANB less than 0°, Wits appraisal less than ‐2 mm (for those who can retrude the mandible to incisal edge‐to‐edge position, the cephalometric film of retrusive position was taken for correction before recruitment), A‐Np < 0 mm; with no other orofacial deficiency (e.g. cleft lip and palate), no orthodontic treatment before Exclusion criteria: none mentioned Setting: Department of Orthodontics, Peking University School and Hospital of Stomatology, Beijing Ethnicity: article stated that participants were of Chinese ethnicity
Interventions	Comparison: facemask with hyrax (RME) versus facemask with double‐hinged expander device alternating expansion and constriction (Alt‐RAMEC) Children in group A received Hyrax expander appliances and those in group B received double‐hinged expander appliances. Four maxillary teeth were banded and meanwhile the wire arm was cemented on the lingual side of the upper incisors. All the appliances were made by one technician in Orthodontic Department, Dental Hospital of Peking University. Group A (n = 18): RME for 7 days, 1 mm/d Group B (n = 16): alternating RME for 7 days, 1 mm/d then constriction for 7 days, 1 mm/d were conducted for 7 weeks and the maxilla was in expansion state in the end. After expansion, the facemask protraction appliance was placed, with orthopaedic force, up to 4～4.5 N per side, in a downward and forward direction 15° to 30°. Children were instructed to wear the facemask for a minimum of 14 hours per day. The indication of the end of treatment: the anterior crossbite was corrected, neutral molar relationship or distal molar relationship.
Outcomes	Outcomes relevant to the review: ANB, Wits appraisal Lateral standardised cephalograms were taken before and after treatment.
Notes	A sample size calculation was not described. The relevant sections of the article were translated from Chinese.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Eligible children were assigned to 2 groups using a random number table.
Allocation concealment (selection bias)	Unclear risk	No method of allocation concealment was mentioned.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	There was no mention of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no missing data. None of the participants was lost to follow‐up.
Selective reporting (reporting bias)	Low risk	The study protocol was reported and all the study’s prespecified outcomes were presented. Article states that the overjet was corrected in all cases.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Liu 2015.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 44 (43 analysed; 20 males and 23 females) Mean age: group 1: 9.81 years (1.72 SD), group 2: 10.11 years (1.44 SD) Inclusion criteria: 7 to 13 years of age, in mixed or early permanent dentition with first maxillary molar erupted; with retrognathic maxilla, Class III malocclusion, anterior crossbite; retrusive middle face; ANB less than 0°, wits appraisal less than ‐2 mm (for those who can retrude the mandible to incisal edge‐to‐edge position, the cephalometric film of retrusive position was taken for correction before recruitment), A‐Np less than 0 mm Exclusion criteria: other orofacial deficiency (e.g. cleft lip and palate); orthodontic treatment before; unfavourable condition of the maxillary dentition for appliance placement Setting: Department of Orthodontics, Peking University School and Hospital of Stomatology, Beijing Ethnicity: article stated that participants were of Chinese ethnicity
Interventions	Comparison: facemask with rapid maxillary expansion (RME) versus facemask with alternating rapid maxillary expansion and constriction (Alt‐RAMEC) Group 1 (n = 21): RME for 2 weeks, 0.5 mm/d. After expansion, the facemask protraction appliance was placed, with orthopaedic force, up to 3.92 to 4.9 N per side, in a downward and forward direction 20° to 30°. Participants were instructed to wear the facemask for a minimum of 14 hours per day. Group 2 (n = 22): alternating RME (Alt‐RAMEC) for 2 weeks, 0.5 mm/d expansion and constriction for 2 weeks, 0.5 mm/d was repeated once then one more RME for 2 weeks, 0.5 mm/d. At the end of 10 weeks, the maxilla was in expansion state. Then the protraction method started as group control. Children in both groups received Hyrax expander appliance. The premolars and molars were banded as anchorage (participants with infraocclusal premolars had the primary molars banded). All palatal expanders were activated on the day of placement and the appliances received two quarter turns (90° per turn). The indication of the end of treatment was that the anterior crossbite was corrected, neutral molar relationship or distal molar relationship.
Outcomes	Outcomes relevant to the review: ANB, Wits appraisal CBCT scans were performed before (T1) and after orthodontic treatment (T2) for all the participants in both groups by using the CBCT scanner (DCT PRO system, VATECH, Korea), which is 0.40 voxel resolution with the scanning parameter of 7 mA, 90 kV, 20 cm x 19 cm window. All the CBCT data (in the DICOM format) were exported into Mimics10.01 software for 3D reconstruction.
Notes	A sample size calculation was based on a previous study.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation was performed and the length of the block was 6. Eligible children were assigned to the groups in order of attendance.
Allocation concealment (selection bias)	Unclear risk	No allocation concealment was mentioned.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding was used.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were accounted for. One participant from group 1 was lost to follow‐up (declined final x‐rays). Per protocol analysis was used.
Selective reporting (reporting bias)	Low risk	The study protocol was reported and all the study’s prespecified outcomes were presented. The article states that the overjet was corrected in all cases.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Ma 2009.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 31 (17 males and 14 females) Mean age: group A: 8.93 years (1.64 SD), group B: 8.53 years (1.46 SD) Inclusion criteria: mixed dentition with anterior cross bite and Class III malocclusion, ANB angles less than 0° and cannot retrude mandible to the incisal edge‐to‐edge position, age 6 to 11 years Exclusion criteria: none mentioned Setting: Department of Orthodontics, School of Stomatology, Hebei Medical University
Interventions	Comparison: facemask with rapid palatal expansion (RPE) versus facemask without RPE Group A (n = 15): the appliance consisted of a banded palatal expander (3M, USA, Hyras type) with soldered vestibular hooks on the first molar and first premolar bands and anterior hooks placed in the distal region to the lateral incisor. The appliance was activated two quarter turns (90° per turn) per day from the day of placement. For children with posterior crossbite, expansion was considered adequate when the occlusal aspect of the maxillary palatal cusps of upper first molars corresponding to the occlusal aspect of the buccal cusps of the lower first molars; for the others, activation period lasted 7 to 10 days until midline diastema was observed between the maxillary incisors, indicating separation of the mid‐palatal raphe. At the end of expansion, each child was fitted with a facemask (Sinya, Hangzhou Sinye Dental Material Co. Ltd, China) for protraction. Elastics were attached to the soldered hooks to produce protraction force up to 4～4.5 N for each side, in a 15 to 30° downward and forward direction. Children were instructed to wear the facemask for a minimum of 14 hours per day. Group B (n = 16): same protraction appliance and facemask as group A with the same force level. Protraction started as the appliance was placed. Those with posterior crossbite received RPE to correct the width discrepancy of the dental arches after protraction.
Outcomes	Outcomes relevant to the review: overjet, ANB, Wits appraisal Each child had cephalometric films taken before and after the treatment by the same technician on the same device.
Notes	A sample size calculation was not described. The relevant sections of the article were translated from Chinese.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A random number table was used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	There was no mention of allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. There was no reliability or repeatability testing undertaken.
Blinding of outcome assessment (detection bias) All outcomes	High risk	There was no mention of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were accounted for.
Selective reporting (reporting bias)	Low risk	All outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Majanni 2016.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 38 (21 males and 17 females) Mean age: group 1: 11.3 years (1.2 SD), group 2: 11.5 years (1.5 SD) Inclusion criteria: Angle’s class III malocclusion; anterior crossbite on two teeth or more or an edge‐to‐edge bite with or without an anterior shift of the mandible during the closure; skeletal class III relationship judged clinically and confirmed radiographically (ANB between 1 and ‐4); normal inclination of the lower incisors with an incisor mandibular plane angle not exceeding 100° and not less than 85°; no facial asymmetry or minimal facial asymmetry (less than 2 mm of deviation of the mandibular midline from the facial midline); patients in late mixed dentition or at the beginning of permanent dentition (dental age between 9 years 6 months and 13 years approximately); lower canines and first premolars should have fully erupted on both sides; no craniofacial syndromes or cleft lip and or palate abnormalities; absence of supernumerary teeth or missing teeth except for the third molars; no previous orthodontic treatment; Syrian ancestry Exclusion criteria: skeletal class III relationship caused predominantly by maxillary deficiency (SNA angle should have been less than 78 with a normal SNB angle); severe skeletal class III resulting primarily from mandibular prognathism (ANB less than –4° with no functional shift on closure); diseases that prevent the application of mini‐implants (e.g. osteoporosis – treated with cortisone and its derivatives treated with radiation); a convergence between the roots of the canine and first premolar assessed radiographically; an indication for rapid maxillary expansion; MM angle greater than 35° or SN‐MP angle greater than 40° Setting: recruited from the Orthodontic Department of University of Al‐Baath Dental School, Homs, Syria Ethnicity: 'Syrian ancestry' specified as part of inclusion criteria
Interventions	Comparison: bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR) Group 1: BAIMT (n = 19) Consisted of (1) upper acrylic plate with posterior smooth bite plate, (2) labial arch 0.7 mm of stainless steel, (3) Adam’s clasps on the upper first permanent molars (0.7 mm stainless steel wire), (4) and hooks (made of 0.9 mm stainless steel wire) for attaching elastic bands placed distal to the first molars. Two self‐drilling mini‐implants (O.S.A.S., Dewimed, Tuttlingen, Germany; 1.6 mm diameter, 8 mm length) were inserted under local anaesthesia into the buccal alveolar bone between the mandibular canine and the first premolar roots on both sides with an insertion angle of about 45 to 60° with the alveolar process. A periapical radiograph was taken beforehand to assure proper insertion without damaging the neighbouring roots. Intermaxillary elastics (American Orthodontics, Sheboygan, WI, USA) were applied between URAs’ hooks and the mandibular anterior mini‐implants, generating a 100‐g force on each side of the jaw in the first week (5/16‐inch) followed by 3/16 medium size in order to generate an orthodontic force of about 200 g on each side until the end of treatment. Children were asked to wear elastics for 18 hours per day and replace elastics on a daily basis or when damaged. Group 2: RMR (n = 19) Components consisted of: 1) upper acrylic base plate with posterior bite planes; 2) retentive elements: mainly two Adam’s clasps on the upper first permanent molars or second upper deciduous molars; 3) upper reversed labial bow (0.9 mm stainless steel) extending to the cervical edges of the mandibular anterior teeth from the labial surface of the lower primary canine on one side to the other labial surface of the contralateral tooth. This bow was activated to hold the mandible in its maximum posterior position; and (4) auxiliary devices: a screw or springs to procline the upper permanent incisors when diagnosed as retroclined or an expansion screw to expand the maxillary dental arch in cases with upper constricted dental arches. Patients were asked to wear the RMR for 16 hours per day, including bedtime. The appliance was activated monthly to adjust the anteroposterior location of the reverse arch in order to maintain the passive contact with the cervical regions of the lower anterior teeth.
Outcomes	Outcomes relevant to this review: overjet, ANB Pain, discomfort and acceptance of the appliances using a questionnaire Lateral standardised cephalograms were taken before treatment (T1), after the end of the active phase of treatment (T2), and 12 months after the beginning of treatment (T3). It was unclear if all radiographs were taken with the same cephalometer.
Notes	The authors described a sample size calculation and accounted for multiple testing of cephalometric variables by using a Bonferroni correction of the significance level. The authors reported the average active phase of treatment. This was 6.3 months in the BAIMT group and 3.4 months in the RMR group. The authors investigated pain, discomfort and acceptance of the appliances using a questionnaire on a sample when further participants had been recruited. These participants were recruited from the same sample as the first paper (2016) to ensure the parallel questionnaire study was not underpowered (n = 56).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomisation by creating a randomisation list using Minitab V16 (Pennsylvania, PA, USA) with an allocation ratio of 1:1
Allocation concealment (selection bias)	Low risk	Allocation sequence concealed from the principal researcher (AMRM) enrolling and assessing participants in sequentially numbered opaque and sealed envelopes. To prevent subversion of the allocation sequence, the name and date of birth of each participant was written on the envelope, and these data were transferred onto the allocation card inside each envelope. Corresponding envelopes were opened only after completing all baseline assessments and when the time came to allocate the intervention.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Clarification was received from one of the authors (MYH). "Although it not mentioned in the paper, lateral cephalograms taken at T2 (i.e. after the end of the active treatment) in the interventional group (the BAIMT group) had the mini‐screws in their places (without being taken off). In order to avoid bias during data analysis, the corresponding lateral cephalograms taken at T2 in the other group (i.e. the RMR group) were manipulated using the Adobe Photoshop program by inserting mini‐screw‐like drawings on the captured images. At T3 (the final assessment time), all the mini‐screws used in the BAIMT group were taken off before image capture. No manipulation was needed at this assessment time."
Incomplete outcome data (attrition bias) All outcomes	Low risk	No participants were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	No other sources of bias were found.

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Mandall 2010.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 73 (34 males and 39 females), 69 analysed after 15 months, 63 at 3‐year follow‐up and 65 at 6‐year follow‐up Mean age: group 1: 8.7 years (0.9 SD), group 2: 9.0 years (0.8 SD) Inclusion criteria: 7 to 9 years old at the time of registration; 3 or 4 incisors in crossbite in the intercuspal position; clinical assessment of a Class III skeletal problem Exclusion criteria: child of non‐Caucasian origin (understood as not white); cleft lip and palate and/or craniofacial syndrome; a maxillo‐mandibular plane angle greater than 35° or lower face height greater than 70 mm; previous history of TMJ signs or symptoms; lack of consent Setting: participants were recruited through UK orthodontic departments at 5 district general hospitals and 3 university teaching hospitals Ethnicity: white ethnicity specified as part of inclusion/exclusion criteria
Interventions	Comparison: facemask versus untreated control Group 1 (n = 35): facemask group: a bonded maxillary acrylic expansion device was placed. This consisted of a metal framework and a midline expansion screw to which 3 mm acrylic was adapted. The appliance was modified, if needed, with acrylic extending over the upper incisor edges to increase appliance retention. 1 vestibular hook was located, on each side, in the upper deciduous first molar position, for elastic traction. The appliance was cemented with glass ionomer cement, but if it later debonded, it was re‐cemented with composite, following acid etching of the buccal and palatal cusps of the upper first permanent molars. For patients with posterior crossbites, the expansion screw was activated one quarter turn (0.25 mm) per day until the lingual cusps of the upper posterior teeth approximated the buccal cusps of the lower posterior teeth. If no transverse change was required, the maxillary splint was still activated once a day for 7–10 days in order to disrupt the circum‐maxillary sutures. A commercially available adjustable facemask was used (TP Orthodontics), which had bilateral vertical rods connected to both chin and forehead pads. This design was adjustable vertically to customise the fit. If patients experienced chin reddening, ventilation holes were drilled through the plastic chin pad or soft padding was added. Elastics were connected bilaterally to the adjustable midline crossbow in a downwards and forwards direction. Patients were asked to wear the facemask for 14 hours per day, continuously, during the evening and night. A co‐operation calendar was used in an attempt to increase treatment compliance, although this was not formally statistically evaluated. Extra‐oral elastics of increasing strength were used (3/80 8 oz elastics for 1–2 weeks; then 1/20 14 oz elastics; then 5/160 14 oz elastics) until a force of 400 g per side was delivered. The direction of elastic traction was downwards and forwards 30° from the vestibular hooks on the bonded maxillary expander to the adjustable crossbar of the facemask. Additionally, the elastics could be crossed over to prevent catching or interference. Group 2 (n = 38): control: following collection of initial records, participants allocated to the control group received no clinical intervention. They were recalled 15 months after registration for collection of final records. Both groups were then recalled for follow‐up at 3 years and 6 years.
Outcomes	Outcomes relevant to this review: overjet, ANB, Piers‐Harris score, Oral Aesthetic Subjective Impact Score (OASIS) score, TMJ outcomes and perceived need for orthognathic surgery Data were collected at baseline, 15 months after baseline data collection, 3 years after baseline data collection, 6 years after baseline data collection (DC4) Cephalometric and occlusal measurements: lateral cephalograms traced by experienced clinician blinded to group allocation. To determine rotations of maxillary and occlusal planes, superimposition of lateral cephalometric radiographs from baseline, 15 months and 3 years was undertaken by another author using Bjork's structural method, which employs the anterior zygomatic process as the reference landmark. PAR scores were measured by a calibrated examiner. Overjet measurements were recorded from study models, with a steel millimetre ruler, by an experienced examiner. Psychosocial measures: the short form of the Piers–Harris children's self‐concept scale (60 questions) (Piers 2002) was used to evaluate self‐concept. Psychosocial/oral health‐related quality of life effects of treatment were assessed using the OASIS (Mandall 2000), which sums the impact of concern about appearance of teeth, including nice comments, unpleasant comments, teasing, avoidance of smiling, covering the mouth because of the teeth and self‐perceived aesthetic component of the Index of Orthodontic Treatment Need. TMJ examination: all the orthodontists involved in the study received training from a TMJ specialist before the start of the study to ensure that the TMJ examination was standardised. This TMJ specialist also advised that an examination appropriate for this age group of children should assess pain (lateral and intra‐auricular), clicking, crepitus, locking, muscle tenderness (temporalis, masseter and lateral pterygoid), and restriction of jaw movement (maximum opening and lateral movement). In addition, the presence of forward mandibular displacement on closure was recorded. TMJ signs or symptoms were recorded at DC1 to ensure no participants might be treated with protraction facemask that may exacerbate any TMJ problems through potential downwards and backwards rotation at the chin point. No patients were excluded at baseline because of pre‐existing TMJ signs or symptoms. Need for surgery in adulthood: at the 6‐year follow‐up, a panel consensus method was used where the 7 orthodontic consultant clinicians met and, as a group, came to a decision for each participant regarding clinical need for orthognathic surgery as ‘yes’ or ‘ no’.
Notes	The authors described a sample size calculation that estimated that 23 children per group would give 90% power to detect a PAR reduction of 25% with a 0.05 2‐sided significance level.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation list generated in blocks of 10 with stratification according to sex because girls and boys would grow at different times during the study and, thus, potentially confound Class III skeletal measurements.
Allocation concealment (selection bias)	Low risk	Computer‐generated randomisation sequence concealed centrally and each clinician telephoned a research assistant to receive treatment allocation after each participant was registered.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The lateral cephalograms were traced by an experienced clinician who was blinded as to group allocation. It was not possible to blind the clinician or the participant in this study. However, the study was single‐blind, as the researchers measuring the radiographs and study models and the statistician were blinded to the treatment/control allocation until the data were analysed and the code broken. Ideally, the clinician collecting the records at the 15‐month time point would also have been blinded as to group allocation. However, this was not attempted, because with only 1 operator involved at each centre, they would have had the participant's notes in front of them at the time of data collection. Also, it was likely that the clinicians would have remembered who had received protraction facemask treatment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 participants were lost to follow‐up in each group, and excluded from the analysis at 15 months after baseline data collection. A further 3 participants were lost to follow‐up in each group, and excluded from the analysis at the 3‐year time point. One participant was lost to follow‐up in the untreated control group and 3 participants returned in the facemask group at the 6‐year time point. This is unlikely to have introduced bias.
Selective reporting (reporting bias)	Low risk	Cephalometric and occlusal measurements, psychosocial measures and TMJ examination results were planned and reported.
Other bias	Low risk	Some participants included in this study had a centric relation to centric occlusion displacement. This may have influenced the perception of the skeletal discrepancy from the lateral cephalogram, but we consider the resulting risk of bias to be minimal.

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Minase 2019.

*Study characteristics*
Methods	3‐arm parallel RCT
Participants	Number recruited: 39 (15 males and 24 females) Mean age: group 1: 10 years (3.8 SD), group 2: 10.2 years (3.7 SD), group 3: 10.3 years (3.6 SD) Inclusion criteria: growing child in the age group 6 to 12 years; anterior crossbite/edge‐edge incisor relationship; Angle’s class III molar relation in permanent dentition or mesial step in deciduous dentition; cephalometrically ANB 0° or less (up to −4°) Exclusion criteria: severe skeletal class III resulting primarily from mandibular prognathism (ANB less than −4°); Class III patients with craniofacial syndromes; cleft lip and palate patients Setting: recruited from the Government Dental College Outpatient Department, Aurangabad, Maharashtra, India
Interventions	Comparison:reverse Twin Block with lip pads and rapid maxillary expander versus facemask with rapid maxillary expander versus untreated control Group 1: modified reverse Twin Block with lip pads and rapid maxillary expander (n = 13). HYRAX screw (Leone Orthodontics and Implantology, Firenze, Italy) was adapted parallel to the occlusal plane with arrows directing posteriorly for ease of activation. Acrylic upper bite blocks were constructed on the occlusal surface extending from canine to first premolar/deciduous canine to deciduous first molar. Lower bite blocks extended from permanent second molar/permanent first molar to second premolar/second deciduous molar. Bite blocks were constructed at 70° to the occlusal plane, configured in reverse of the conventional Twin Block. The attached lip pads were rhomboidal in shape, 8 mm in height, 12 mm from the incisal edge, and not joined in the midline. The appliance was cemented by using glass ionomer type‐I luting cement (GC Fuji I). Group 2: facemask with rapid maxillary expander (n = 13). A bonded acrylic palatal expansion appliance with HYRAX screw (Leone Orthodontics and Implantology, Firenze, Italy) was constructed with hooks between canine and first premolar/first deciduous molar for attachment of the force delivering elastics. Appliance was cemented using glass ionomer type‐I luting cement. A Petit facemask was adjusted such that after elastic placement, the direction of force would be 30° downward to the occlusal plane. Initially, for 2 months, a force of 8 oz per side was given, which was increased to 14 oz per side for the next 7 months. Force was measured with a Dontrix gauge. Group 3: untreated control (n = 13) Activation of HYRAX screw in both treatment groups started from the second day of appliance cementation, beginning with one turn on the first day and then increased to twice daily thereafter until the crossbite was over‐corrected. All participants were reviewed on a 4‐week interval basis. Reverse Twin Block and Petit facemask were discontinued following the establishment of a positive overjet and overbite, and records were taken at this stage (time point 2). Immediately after discontinuation of appliances, participants were given fixed modified transpalatal arch with anterior extension as retention appliance.
Outcomes	Outcomes relevant to the review: ANB, Wits appraisal Lateral cephalograms were taken at the start of the treatment and after 9 months of treatment in the 3 groups. The cephalograms were taken in the same cephalostat with teeth in habitual occlusion and lips in repose.
Notes	A sample size calculation was described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomisation was performed by creating a randomisation list using Minitab V16 (Minitab Inc., PA, USA) with an allocation ratio of 1:1:1.
Allocation concealment (selection bias)	Unclear risk	Not declared
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. It was unclear how many clinicians provided the treatment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Clarification was received from one author (UHD). Time point 2 measurements were taken after removal of RME and settling of occlusion.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No participants were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Miranda 2021.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 40 (35 analysed; 21 males and 14 females) Mean age: group 1: 10.7 years (0.9 SD), group 2: 11.5 (1.2 SD) Inclusion criteria: both sexes; late mixed or early permanent dentition; skeletal class 3 malocclusion with maxillary deficiency (Wits appraisal of less than 1 mm); and anterior crossbite or incisor edge‐to‐edge relationship Exclusion criteria: history of previous orthodontic treatment; non‐erupted mandibular permanent canines; special needs or syndromic patients Setting: Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil; Ethnicity: article stated that participants were Brazilians of mixed ethnicity
Interventions	Comparison:Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics Group 1: Hybrid Hyrax (HH) group (n = 20). A Hybrid Hyrax expander consisting of a midline transverse expansion screw anchored by two para‐midline suture miniscrews in the anterior maxilla. A pre‐manufactured hybrid expander (PecLab Ltda., Belo Horizonte, MG, Brazil) was supported by bands on the maxillary first permanent molars and 2 miniscrews with 1.8 mm diameter, 7 mm length, and 4 mm transmucosal length were installed in the screw slots after placement of the expander. Group 2: conventional Hyrax (CH) group (n = 15). A conventional Hyrax (CH) expander with a midline transverse expansion screw and supported by bands on the maxillary first permanent molar. Both groups: in the mandible, 2 miniscrews with 1.6 mm diameter, 6 mm length, and 1 mm transmucosal length were placed on the buccal aspect between the permanent canines and first premolars at the level of the mucogingival junction. The screw activation protocol and Class III elastics were similar for both groups. The expander screw was activated 1/4 turn twice a day for 14 days, achieving 5.6 mm expansion. In the maxillary molar bands, distal hooks of 1 mm‐round, stainless steel wire were soldered to accommodate the Class III elastics and provide a more horizontal force. The Class III elastics were used from the maxillary molar distal hooks to the mandibular miniscrews. Traction started with a load of 150 g of force per side in the first month and 250 g of force per side in the following period. Patients were instructed to wear the elastics full time, changing them every morning and night. Composite build‐ups on the occlusal aspect of the mandibular permanent first molars were used to open the bite during maxillary protraction.
Outcomes	CBCT was obtained before (T1) and after treatment (T2) with the i‐CAT 3D system (Imaging Sciences International, Hatfield, Pa). The protocol of 120 kVp, 5 mA, 0.25‐mm voxel size, scan time of 40 s, and field of view of 13 cm in height x 16 cm in depth was used. The head orientation was standardised in the right sagittal view positioning the Frankfurt plane parallel to the horizontal plane; in the frontal view, the orbital plane was positioned parallel to the horizontal plane; and in the axial view, and the midsagittal plane passed through the anterior and posterior nasal spines. Outcomes relevant to the review: overjet, ANB, Wits
Notes	The authors performed an intention‐to‐treat analysis (ITT).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation process was performed on a randomisation website (www.randomization.com).
Allocation concealment (selection bias)	Low risk	"Allocation concealment corresponded to opaque, sealed and sequenced numbered envelopes. Each envelope contained the group name according to the randomisation sequence. A different operator was responsible for randomisation sequence generation, allocation concealment, and processing. The allocation process started after recruitment for the patients who met the inclusion criteria and signed the informed consent. Before opening the envelope, the patient's name and allocation date were irreversibly identified on the external surface. Inside each envelope, a card containing the group name was found."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding was not possible due to the nature of the interventions. All participants were treated by the same clinician.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	CBCT scans were anonymised before assessment. The statistician was also blinded during the analysis.
Incomplete outcome data (attrition bias) All outcomes	High risk	During treatment, undesirable dental effects in the maxillary arch were observed in the CH group. For ethical reasons, treatment in the CH group was interrupted after 11 months of trial commencement and before appliance installation in the last 5 volunteers. "Twenty patients were allocated to the CH group. However, the last 5 participants were not treated because of collateral effects during therapy in 2 out of 15 patients in treatment." No dropout from HH group; 25% from CH group.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Seiryu 2020.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 41 (2 refused to participate so 39 randomised; 24 males and 15 females) Mean age: group 1: 10 years, 5 months (1 year, 8 months SD), group 2: 11 years, 1 month (1 year, 3 months SD) Inclusion criteria: skeletal Class III (ANB ≤ 2.5^o), measured by inspection of initial lateral cephalograms; overjet ≤ 0 mm, measured during initial cast analysis; undergoing circumpubertal phase of skeletal development (CVMS II–IV); no congenital or systemic disease; no skeletal asymmetry; no missing teeth; no temporomandibular joint disorder Exclusion criteria: not reported Setting: recruited from the Tohoku University Hospital Orthodontic Clinic, Japan Ethnicity: article stated that participants were of Japanese ethnicity
Interventions	Comparison:facemask with transpalatal arch versus facemask with transpalatal arch and miniscrew Group 1: facemask TPA (n = 20). A protractive force of 500 g (250 g per side) was applied from the facemask to the hooks by the use of elastics. Patients were instructed to use their facemask for 12 hours per day. The direction of the traction force was < 3^o from the occlusal plane. Group 2: facemask TPA with miniscrew (n = 19). A miniscrew (Absoanchor Dentos Inc., Taegu, Korea; diameter 1.4 mm, length 8 to 10 mm) was inserted under local anaesthesia in the anterior region of the palate via the self‐tapping method. The positions of the miniscrews were assessed with cone‐beam computed tomography before and after insertion. At 3–4 weeks after miniscrew implantation, mobility of the miniscrew was checked and the lingual arch was set. The transpalatal arch was attached to the miniscrew by tying with a ligature wire and fixing with resin. The protractive force used and duration of wear of the elastics was the same as described above. A transpalatal arch with soldered hooks was fixed to the maxillary arch in both groups.
Outcomes	Outcomes relevant to the review: ANB Lateral cephalograms were taken at initial observation (T1) and after facemask therapy (T2). It is unclear if all images were taken in the same cephalostat. The authors reported that "no serious harm to the patients was observed during treatment".
Notes	Calculation of sample size was based on a previous study. The treatment period was set at more than a year and the authors reported on the treatment intervals for each group. These were 1 year 9 months (9.9 SD) in the facemask with miniscrew group and 1 year 9 months (10.2 SD) in the facemask alone group. The authors reported that there were no harms in the study. 3 miniscrews were changed when the root proximity was found to be close on confirmatory CBCT. They also reported a high success of the miniscrews.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomisation was computer‐generated by use of a software program (R version 3.0.3, R Foundation for Statistical Computing, Vienna, Austria) in a 1:1 ratio.
Allocation concealment (selection bias)	Low risk	Allocation was performed by someone not involved in the study. The children were randomly allocated into two groups using sequentially numbered, opaque, and sealed envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The investigator who analysed the cephalograms was blinded regarding the origin of the films and the group to which the individual participants belonged. All data were labelled with numbers and sent to the statistician, who was also blinded to the group. However, clarification was received from one of the authors (TT) that "the cephalometric radiographs of T2 were taken before removing the miniscrew."
Incomplete outcome data (attrition bias) All outcomes	Low risk	No participants lost to follow‐up.
Selective reporting (reporting bias)	Low risk	The main outcome of the study was determination of the effect of treatment in terms of skeletal and dentoalveolar change. A secondary outcome was that of the success rate for use of the miniscrew. All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Showkatbakhsh 2012.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 42 (19 males and 23 females) Mean age: group 1: 8.9 years (1.4 SD), group 2: 9.2 years (1.1 SD) Inclusion criteria: SNA < 80 degrees; SNB < 80 degrees; ANB < 0 degrees; class III molar relationship; no mandibular shift; negative overjet; no congenital disease or endocrine disorders; no previous orthodontic treatment and surgical intervention Exclusion criteria: not reported Setting: not stated
Interventions	Comparison: facemask versus reverse chin cup Group 1: facemask group (n = 21): received a Multi‐Adjustable face mask (Ortho Technology Inc., Tampa, FL, USA) and a fully‐anchoraged removable appliance in the upper jaw. The upper removable appliance had two Adams clasps on the permanent first molars, two C clasps on the primary canines, and two C clasps on the permanent central incisors. If necessary, the number of C clasps and Adams clasps could be increased for anchorage reinforcement. Two hooks were mounted on the right and left buccal segments. Two orthodontic latex elastics (5/16 inch, medium size) connected the hooks of the upper removable appliance to the horizontal crossbar of the face mask in order to deliver approximately 500 g of force. The patients were instructed to wear the appliance full‐time except for eating, contact sports and tooth brushing. Group 2: chin cup group (n = 21): this upper removable appliance had two Adams clasps on the permanent first molars, two C clasps on the primary canines and two other C clasps on the permanent central incisors. If necessary, the number of C clasps and Adams clasps could be increased for anchorage reinforcement. A porous acrylic chin cup with two vertical arms (1 mm stainless steel) was fabricated for each individual patient. The end of each arm was bent to form a hook. Two orthodontic latex elastics (5/16 inch, heavy size) connected the hooks of the palatal canine area of the upper removable appliance to the hooks of the reverse chin cup in order to deliver approximately 500 g of force on each side. A high pull head cap was used to hold the reverse chin cup. The patients were instructed to wear the appliance full‐time except for eating, contact sports and tooth brushing.
Outcomes	Outcomes relevant to this review: ANB Lateral cephalograms, panoramic radiographs, photographs and study casts of the participants in both groups were taken before and after treatment.
Notes	A sample size calculation was carried out on the basis of the difference in means and standard deviation of the changes in SNA from previous studies, similar in nature to the current one, in which changes of SNA were 0.7 degrees (SD: 0.6). For an alpha level of 0.05, a sample size of 20 per group was necessary to achieve a power of 0.90. Considering these studies, following published guidelines and considering probable dropouts, an optimal sample size of 42 participants was chosen for this study.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An unstratified allocation sequence was generated by computer programme (Etcetra Version 2.59); random numbers were generated.
Allocation concealment (selection bias)	Low risk	Assignment was carried out by one of the investigators, thus concealing allocation from the clinician until the time of the appointment at which the appliance was to be placed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. Treatment was carried out by one clinician.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The treating clinician was blinded to the randomisation procedure, but because of clear differences in appliance design, blinding was not possible during the treatment period. Does not mention if there was blinding during the assessment of the radiographs.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported, but overjet was not an outcome.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Showkatbakhsh 2013.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 50 (47 analysed; 22 males and 25 females) Mean age: group 1: 9 years (1.2 SD); group 2: 9.1 years (0.9 SD) Inclusion criteria: SNA ≤ 80 degrees, SNB ≤ 80 degrees, ANB ≤ 0 degrees according to the initial lateral cephalograms; no syndromic or medically compromised patients; no previous surgical intervention; no use of other appliances before or during the period of functional treatment; no skeletal asymmetry; Class III molar relationship; classified as pre‐pubertal (CS1, CS2 and CS3) according to a recently improved version of the cervical vertebral maturation (CVM) method Exclusion criteria: not reported Setting: Department of Orthodontics, SB University of Medical Sciences Dental School, Tehran, Iran
Interventions	Comparison: facemask versus tongue plate appliance Group 1 (n = 24): Multi‐Adjustable Facemask (Ortho Technology, Inc., Tampa, FL, USA) and a full anchorage removable appliance in the upper jaw. The upper removable appliance had two Adams clasps on the permanent upper first molars, two C clasps on the primary canines and two other C clasps on the permanent central incisors. If necessary, the number of C clasps and Adams clasps could be increased for anchorage reinforcement. Two hooks were mounted on the right and left buccal segments. Two orthodontic latex elastics (5/16 inch, medium size) connected the hooks of the upper removable appliance to the horizontal crossbar of the facemask in order to deliver 500 g of force. The patients were instructed to wear the appliance full‐time except for eating, contact sports and tooth brushing. Group 2 (n = 23): tongue plate appliance. A tightly fitting and well‐retained upper removable appliance was fabricated with Adams clasps on the upper first permanent molars and C clasps placed on the upper primary canines. Additional C clasps were added if more retention was needed. An acrylic plate was mounted posterior to the upper incisors. The patients were instructed to wear the appliance full‐time except for eating, contact sports and tooth brushing. The patients were examined and progress was observed after each monthly visit. The tongue plate was changed every 6 months.
Outcomes	Outcomes relevant to the review: ANB Cephalometric lateral skull radiographs, orthopantomograms (OPG), clinical photographs and study casts of participants in both groups were taken before and after treatment.
Notes	"The sample size for the present study was calculated based on a significance level of 0.05 and a power of 90% to detect a minimum clinically significant change of 1.3^o in SNA."
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An unstratified allocation sequence generated by computer program (Etcetra Version 2.59, Copyright J. H. Abramson 2006‐11), with random numbers generated.
Allocation concealment (selection bias)	Unclear risk	Assignment concealed from the clinician until the time of appliance placement. Method of concealment unclear.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants. All treatment was carried out by the same clinician.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The treating clinician was blinded from the randomisation procedure; however, because of clear differences in appliance design, blinding was not possible during the actual treatment. At the time of data collection, the clinician carrying out the measurements was blinded to the treatment allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The authors presented a CONSORT flow diagram which showed that 3 participants were lost to follow‐up before the final assessment and were therefore not included in the data. We considered this a low attrition rate.
Selective reporting (reporting bias)	Low risk	All expected outcomes reported, but overjet was not an outcome.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Vaughn 2005.

*Study characteristics*
Methods	3‐arm parallel RCT
Participants	Number recruited: 46 (24 males and 22 females) Mean age: group A: 7.38 years (0.5 SD), group B: 8.11 years (0.52 SD), group C: 6.63 years (0.47 SD) Inclusion criteria: 0 or negative overjet on 2 or more incisors, Class III molar relationship with the mesiobuccal cusp of the maxillary permanent first molar distal to the buccal groove of the mandibular first permanent molar, or a mesial step terminal plane relationship of 3.0 mm or more if the deciduous molars were present (measured clinically). When the clinical or dental criteria were borderline, cephalometric criteria of ANB angle of 0 ° or less, Wits analysis of 3 mm or more, and nasion perpendicular to A‐point of 2 mm or less Exclusion criteria: any craniofacial anomaly, psychosocial impairment or skeletal open bite Setting: university hospital in USA
Interventions	Comparison:facemask with expansion versus facemask only versus untreated control Group A (n = 15): facemask with expansion ‐ treated with palatal expansion with facemask therapy. A banded, soldered, jackscrew palatal expansion appliance was used for each participant. 2 teeth per side were banded: the first and second deciduous molars, first permanent molar and second deciduous molar, or first permanent molar and premolar. The appliance was activated twice daily (0.5 mm/day) for a minimum of 7 days. Soldered hooks (0.045 in) were extended to the mesial of the canine for attachment of the force‐delivering elastics. Each facemask was fabricated on a model made from an impression of the participant's face. The facemask was fitted 7 to 10 days after the placement of the palatal appliance. Elastics, directed 15° to 30° downward from the occlusal plane, delivered a force of 300 to 500 g per side, as determined by a force gauge. The participants were instructed to wear the appliance full time at the beginning of treatment. Compliance was closely monitored with timecards. Once positive overjet and overbite and Class I molar occlusion were obtained, facemask wear was reduced to 14 hours a day. In anticipation of some relapse, over correction, approaching an end‐to‐end molar relationship and overjet of 4 to 5 mm, were the treatment objectives. The treatment results were maintained for 3 to 6 months with nighttime wear. Group B (n = 14): facemask only group: the protocol in group 2 was identical to that for group A except that the palatal expander was not activated. If participants required transverse expansion, this was performed after final records (T2) were obtained. Group C (n = 17): control group: initial records were taken at enrolment (T0) and 1 year later (T1).
Outcomes	Outcomes of relevance to the review: ANB, Wits appraisal Lateral cephalometric radiographs were taken at T0, T1, and T2 for the control group, and at T1 and T2 for the 2 treatment groups.
Notes	A sample size calculation was not described. The study is likely to be underpowered to detect a difference between groups A and B.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"We used a block randomisation table to assign the subjects to 1 of 3 groups after obtaining proper informed consent".
Allocation concealment (selection bias)	Unclear risk	There was no method of allocation concealment mentioned. We attempted to contact the authors for clarification but we have not yet received a response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The principal investigator was blinded to the assignment.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Number of dropouts was not clear in the text. We attempted to contact the authors for clarification but we have not yet received a response.
Selective reporting (reporting bias)	Low risk	All planned outcomes reported, but overjet was not an outcome.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Xu 2001.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 60 (27 males and 33 females), 40 analysed (see Notes below) Mean age: 9.3 years (range 8 to 11) Inclusion criteria: children with skeletal anterior crossbite and abnormal facial morphology Exclusion criteria: tooth or functional Class III patients Setting: Department of Orthodontics, Peking University Scool of Stomatology, Beijing, China
Interventions	Comparison:facemask versus untreated control Group 1 (n = 20): a jackscrew rapid palatal expander welding with the bands of maxillary first molar and first premolar was attached to the patient's posterior teeth. The protraction hook was located in the position of maxillary canines. After the first week of expander placement, the expander was activated with 90° winding each time, twice per day. After 2 weeks, active expansion treatment was stopped and the maxillary protraction started. The protraction treatment used a force of 400 g to 500 g and lasted 12 hours per day. Group 2 (n = 20): observation only Duration of treatment: 11 to 13 months (mean 11.3 months)
Outcomes	Outcomes relevant to this review: ANB Lateral cephalometric films taken at baseline and 11 to 13 months (right after the treatment), on which 9 linear and 6 angular measurements were made
Notes	A sample size calculation was not described. The relevent sections of the paper were translated from Chinese. Although unclear from the paper, it seems that initial incorrect enrolment of "pseudo" Class III patients led to the exclusion of 20 of the 60 participants, leaving 40 to be analysed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The article states "the children were randomly divided into two groups", but no further details were given. We attempted to contact the authors for clarification but we did not receive a response.
Allocation concealment (selection bias)	Unclear risk	The method of allocation concealment was not described. We attempted to contact the authors for clarification but we did not receive a response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	There was no mention of blinding of the assessor. We attempted to contact the authors for clarification but we did not receive a response.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All the participants with skeletal Class III were assessed.
Selective reporting (reporting bias)	Low risk	All expected outcomes reported, but overjet was not an outcome.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Yao 2015.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 34 (16 males and 18 females) Mean age: 10.89 years (range 8 to 13) Inclusion criteria: at the mixed or early permanent dentition stage; with all the first molars erupted to facilitate good retention of the maxillary appliance; the middle 1/3 of the face was sunken; crossbite in the anterior teeth; the lower jaw could retreat to the edge to edge position; ANB < 0 Exclusion criteria: previous orthodontic treatment Setting: Department of Orthodontics, Nantong Stomatology Hospital, Nantong, China
Interventions	Comparison:facemask and RME with alternating expansion and constriction versus facemask and RME with expansion only Group 1: RME with alternating expansion and constriction (n = 17). RME for 7 days, 1 mm per day then constriction for 7 days, 1 mm per day. The cycle repeated until the end of the 7th week, when the appliance was in the state of expansion, and would not be constricted again. Group 2: conventional RME (n = 17). RME for 7 days, 1 mm per day Both groups wore a removable maxillary spiral expansion appliance with Adams clasps. The proximate hooks were put in the upper premolar area in order to get better retention. After the expansion, each participant wore a maxillary protraction mask. The protraction force was applied with a forward and downward direction at a 15 to 30 degree angle to the occlusal plane. The protraction force was 3.92 to 4.90 N on each side and lasted at least 12 hours each day.
Outcomes	Outcomes relevant to the review: ANB, A‐Np (taken as an approximate change to reflect overjet) All participants had cephalometric radiographs recorded before and after treatment, using the same criteria.
Notes	The relevant sections of the article were translated from Chinese. It was unclear if a sample size calculation was described.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A random number table was used to allocate participants by remainder method. There were 17 participants in the test group (7 boys and 10 girls) and 17 in the control group (6 boys and 11 girls).
Allocation concealment (selection bias)	Unclear risk	The article was translated from Chinese. One dentist measured the hard tissue landmarks although it was not stated if they were blinded. We attempted to contact the author to clarify allocation concealment but have received no response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not possible to blind outcome assessors as different appliances used.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The article was translated from Chinese. We contacted the author to clarify risk of attrition bias but have received no response.
Selective reporting (reporting bias)	Low risk	All planned outcomes reported, but overjet was not an outcome.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Yavan 2023.

*Study characteristics*
Methods	3‐arm parallel RCT
Participants	Number recruited: 51 (45 analysed; 24 males and 21 females) Mean age: group 1: 10.54 years (0.77 SD); group 2: 10.49 years (0.53 SD); group 3: 10.66 years (0.65 SD) Inclusion criteria: not explicitly stated, however participants were described as having an ANB angle of less than 0°; SNA angle of less than 78°; presence of centric relationship (CR)–centric occlusion (CO) discrepancy determined by functional analysis (an edge‐to‐edge position of incisors after posterior movement of the mandible); Angle Class III molar relation; no history of orthodontic treatment; no syndrome or craniofacial anomaly Exclusion criteria: skeletal class III malocclusions caused by mandibular prognathism; a high angle growth pattern (SN/GoGn greater than 36°); congenitally missing teeth; systemic or periodontal syndromes Setting: Department of Orthodontics, Faculty of Dentistry, Gaziantep University, Gaziantep, Turkey Ethnicity: article stated that participants were of Turkish ethnicity
Interventions	Comparison:facemask (RME) versus Reverse Forsus versus untreated control Group 1: facemask (RME) (n = 15). A facemask appliance was applied together with an acrylic cap splint‐type rapid palatal expander that was used as the maxillary unit of the facemask/RME appliance. The RME appliance was cemented onto the upper teeth. In children with posterior crossbite, the expansion protocol was applied twice a day until the cross‐bite was over‐corrected. In patients without posterior crossbite, the expansion appliance was activated twice a day for 7 days. Extra‐oral elastics were applied from hooks placed in the canine region on the buccal sides of the expanders. A force of 400 to 500 g per side was applied and the direction of force was approximately 30 degrees below the occlusal plane. Patients were instructed to wear the facemask/RME appliance for at least 18 hours a day until a 4‐ to 5‐mm overjet was achieved, and then only at night. At the end of the application period, the appliances were removed and the post‐treatment results were recorded. Subsequently, all the patients were asked to use a chin cap only at night until the permanent dentition was completed and fixed treatment was initiated. Group 2: Reverse Forsus (n = 15). The Reverse Forsus (RF) appliance consisted of three parts: a maxillary unit, a mandibular unit, and push rods. The maxillary unit was formed on the upper jaw model by soldering the right and left buccal auxiliary arches to the molar bands together with the transpalatal arch. On the lower jaw model, a mandibular unit was created consisting of the EZ2 module of the Forsus fatigue resistant device (3M Unitek Corp, Monrovia, CA, USA), a lingual arch, and an acrylic plate combining these units. The mandibular unit was cemented onto the lower teeth. The lateral acrylic bite blocks were adjusted until all posterior teeth were in contact and a 1‐ to 2‐mm gap remained between the anterior teeth. Subsequently, the push rods were attached to the EZ2 module and buccal auxiliary arches. The directions of the push rods were adjusted to 10 to 25 degrees below the occlusal plane and to a force intensity of 150 to 200 g on each side. As the RF is a fixed appliance, it was active for 24 hours per day. Participants were followed up 1 week after the application of the RF and they continued follow‐up visits every 2 weeks without further activation until 4‐ to 5‐mm overjet was gained. At the end of the active treatment period, all the appliances were removed and the post‐treatment results were recorded. An RME appliance and a chin cap were applied for at night use in individuals who needed maxillary expansion, whereas in individuals who did not require expansion, a positioner appliance was inserted and the patients were asked to wear it only at night until the permanent dentition was completed and fixed treatment was initiated. Group 3: untreated control (n = 15). No treatment was applied for 6 months. At the end of the observation period, participants were treated using predetermined treatment protocols. In the control group, a second radiograph was taken after the observation period and this was used as the initial record for the following routine treatment. Radioprotective measures such as collimation, filtration, and the fastest receptor type were used to further reduce the already low exposure dose of digital radiographs.
Outcomes	Outcomes relevant to the review: overjet, ANB Pre‐ and post‐treatment/observation lateral cephalograms were taken in centric occlusion and according to the natural head position and after a usual swallow. All the cephalograms were obtained by the same technician.
Notes	Abbreviation RPE (rapid palatal expansion) was changed to RME (rapid maxillary expansion) to conform with comparisons described in the review.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The 45 participants were randomly divided into three groups based on age and sex by a statistician using computer software.
Allocation concealment (selection bias)	Low risk	Concealed allocation was performed using opaque, sealed envelopes containing the participant list of each group, which were provided by another researcher before the first session.
Blinding of participants and personnel (performance bias) All outcomes	High risk	During the study, it was not possible to blind the participants and the researcher who administered the treatment. All participants were treated by the same clinician.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The researcher who performed the cephalometric measurements and the statistician who conducted the statistical analyses after treatment were blinded to the clinical data of the groups.
Incomplete outcome data (attrition bias) All outcomes	Low risk	51 randomised; 45 analysed; 6 (12%) lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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Zhang 2018.

*Study characteristics*
Methods	2‐arm parallel RCT
Participants	Number recruited: 34 (20 males and 14 females) Mean age: group 1: 10.3 years (1.6 SD), group 2: 9.9 years (1.7 SD) Inclusion criteria: children in mixed dentition period; no orthodontic treatment experience, no trauma or congenital malformations; lateral cephalometrics were taken before correction Exclusion criteria: history of cleft lip and palate; lack of more than 1 tooth per half arch; surgical history of oral and maxillofacial trauma; history of temporomandibular joint disease Setting: recruited from the Orthodontics Department of Daqing Oilfield General Hospital, China
Interventions	Comparison:facemask with frame internal fixation versus Frankel III functional appliance Group 1: facemask with frame internal fixation (n = 17). The frame appliance was fabricated according to the following method: bands were tried on the first premolar and the first molar, then the refractory model was produced. Bands for maxillary first permanent molar, second deciduous molars, first deciduous molars (or first premolar), maxillary palatine frame, and traction hook were made from 1.2 mm stainless steel wire and welded together using silver welding. The strength and force vector of the elastics was not described. Group 2: Frankel III functional appliance was used for the control group (n = 17). It consisted of lip bumper, cheek panel, palatal arch, upper anterior teeth lingual arch, and lower lip arch. The upper lip bumper should leave the alveolar 2.5 mm from the upper edge of the turning point of mucosa. All participants had a 1‐week initial trial to wear and test the tenderness and comfort of the appliance. Wearing time was gradually extended. Other than eating, strenuous exercise, and language training courses, appliances were worn at least 14 hours per day, mainly in the daytime.
Outcomes	Outcomes relevant to the review: ANB, Wits Cephalograms were taken "1 year before (T1) and after treatment (T2)". All radiographs were taken by Siemens 128‐row CT (SOMATOM Definition Flash).
Notes	A sample size calculation was not described. The authors reported on treatment times for each group in months and number of return visits. Treatment time for the facemask group was 7.1 months (± 2.3 SD) and Frankel III group 9.5 months (± 4.1 SD). The number of visits was 8.4 months (± 2.6 SD) and 10.1 months (± 3.5 SD), respectively.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Research participants were divided into an experimental group and control group, according to the random number table method, with 17 cases in each group.
Allocation concealment (selection bias)	Unclear risk	Not declared.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the interventions, it was not possible to blind the participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not declared.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No participants were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	Low risk	The study appears to be free of other sources of bias.

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ANB: A point–Nasion–B point; A‐Np: A‐point to nasion perpendicular distance; ANPog: a measure equivalent to ANB angle; CBCT: cone beam computed tomography; cm: centimetre; CS: cervical stage; CVMS: cervical vertebral maturation stage; d: day; D: dimension; FH: Frankfort horizontal plane; g: gram; mm: millimetre; N: newton; Nperp‐A (or A‐NPerp): A‐nasion perpendicular; oz: ounces; PAR: peer assessment rating; RME: rapid maxillary expansion; RPE: rapid palatal expansion; SD: standard deviation; SN/GoGn: Sella‐Nasion‐Gonion‐Gnathion; SN–GoMe: sella‐nasion to Gonion‐Menton; SNA: Sella–Nasion–A point; SNB: Sella–Nasion–B point; T: time point (e.g. T0 = baseline assessment time point); 3D: three‐dimensional; TMJ: temporomandibular joint

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Akhoundi 2009	Not RCT
Altug 1989	Retrospective control group therefore not prospective RCT
Arman 2004	Retrospective control group therefore not prospective RCT
Arman 2006	Retrospective control group therefore not prospective RCT
Baik 1995	Retrospective control group therefore not prospective RCT (author contacted)
Barrett 2010	Retrospective control group therefore not prospective RCT
Bavbek 2014	Retrospective therefore not RCT
Biren 1993	Not RCT
Bozkaya 2017	Not RCT
Celebi 2020	Did not measure an outcome of interest
Celikoglu 2014	Matched control group, not RCT
Celikoglu 2017	Not RCT
Cha 2011	Not RCT
Chen 2011	Control group refused or discontinued treatment, not RCT
Cozza 2004	Not RCT
El 2010	Analysed condylar position during treatment, not an outcome of interest in this review
Erdur 2020	Retrospective, not measuring an outcome of interest
Franchi 2014	Retrospective study, not RCT
Gokalp 2010	Not RCT
Goyenc 2004	Not RCT
Halicioglu 2014	Retrospective study, not RCT
He 2013	Retrospective, not RCT
Hino 2014	Consecutive patients, not RCT
Ierardo 2018	Not RCT
Isci 2010	Not RCT
Kaygisiz 2022	Retrospective, not RCT
Kilicoglu 1998	Unable to contact authors to confirm allocation method
Kurt 2011	Not RCT
Lee 2012	Not RCT
Lee 2019	Retrospective
Loca‐Apichai 2022	Not RCT
Lucchi 2022	Not RCT
Miamoto 2017	Not treatment for Class III malocculsion
Mucedero 2007	Not RCT
Papageorgiou 2016	Overview of reviews, not RCT
Pavoni 2009	Not RCT
Pilehvar 2021	Observational study, not RCT
Saleh 2013	Did not measure an outcome of interest
Sar 2011	Not RCT
Sar 2014	No randomisation and compared retrospectively, not RCT
Solano‐Mendoza 2012	Not RCT
Tortop 2007	Retrospective control group therefore not prospective RCT
Tortop 2014	Retrospective, not RCT
Ucem 2004	Not RCT
Ulgen 1994	Not RCT (contact with author)
Wang 2018	Did not report an outcome of interest
Wiedel 2014	Treatment for anterior crossbite
Wilmes 2009	Participants over 16 years of age
Yagci 2010	Not RCT
Yagci 2011	Retrospective
Zaidao 2017	Not RCT
Zere 2018	Review article, not RCT
Zhang 2008	Did not measure an outcome of interest
Zhao 2015	Treatment postponed in control group, not RCT

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Characteristics of studies awaiting classification [ordered by study ID]

Liu 2022.

Methods	Unknown
Participants	Condition: class III skeletal malocclusion with a midface deficiency Inclusion criteria: age 7 to 13 years old before treatment with a midface soft tissue deficiency; fully erupted maxillary first molars, Class III malocclusion, and anterior crossbite; ANB less than 0 degree, Wits appraisal less than ‐2 mm, and distance from Point A to nasion perpendicular less than 0 mm (corrected cephalometric tracing technique was applied for patients with a functional shift)
Interventions	Control group: rapid maxillary expansion facemask protocol Experimental group: alternate rapid maxillary expansions and constrictions facemask protocol
Outcomes	Primary outcome: A‐VRP Secondary outcomes: wide range of other cephalometric measurements, e.g. SNA, SNB, ANB, etc.
Notes	Awaiting translation

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ANB: angle between the maxilla and the mandible; A‐VRP: A vertical reference plane; SNA: angle between sella, nasion and subspinale point A; SNB: angle between sella, nasion and supramentale point B

Characteristics of ongoing studies [ordered by study ID]

ACTRN12622000310763.

Study name	Evaluation of two types of treatment for adolescent patients with protrusion of lower jaw and constriction of upper jaw
Methods	Allocation to intervention: parallel RCT Sequence generation: computer‐generated random number system using Minitab 16 software Allocation sequence concealed using sequentially numbered, opaque, sealed envelopes Participant blinding: yes
Participants	Inclusion criteria: both males and females;Angle’s class III malocclusion; anterior crossbite on two teeth or more or an edge‐to‐edge bite with or without an anterior shift of the mandible during the closure; skeletal class III relationship judged clinically and confirmed radiographically (– 4 < ANB < + 1); normal inclination of the lower incisors with an incisor mandibular plane angle (IMPA) not exceeding 100° and not less than 85°; an indication for maxillary expansion (maxillary constriction); growing patients between 12 and 15 years of age; permanent dentition; no craniofacial syndromes or cleft lip and/or palate abnormalities; absence of supernumerary teeth or missing teeth except for the third molars; no previous orthodontic treatment; Malaysian Exclusion criteria: skeletal class III relationship caused predominantly by maxillary deficiency (SNA angle should have been less than 78 with a normal SNB angle); severe skeletal class III resulting primarily from mandibular prognathism (ANB less than – 4° with no functional shift on closure); patients with diseases that prevent the application of mini‐implants (e.g. osteoporosis – treated with cortisone and its derivatives‐ treated with radiation); convergence between the roots of the canine and first premolar assessed radiographically; facial asymmetry (more than 2 mm of deviation of the mandibular midline from the facial midline); MM angle greater than 35° or SN‐MP angle greater than 40°; one of parents not Malaysian
Interventions	BAIMT with RME versus RMR with SME Experimental group: bone‐anchored intermaxillary traction associated with rapid maxillary expansion (BAIMT with RME) Duration of procedure will be about 12 months including sagittal and transverse correction stage and retention stage. Procedure will be carried out initially by orthodontist and later by participant or parent. The participant or parent will activate expander twice daily (0.4 mm) until overcorrection of maxillary constriction about 2 to 3 mm is achieved. Orthodontic procedures in active phase period: appliance consists of: 1) bonded modified Hyrax palatal expander with occlusal splints bonded with GIC on upper premolars/deciduous molars and upper first molars, 2) hooks (made of 0.9 mm stainless steel wire) for attaching elastic bands placed distal to first molars. Two self‐drilling mini‐implants (1.6 mm diameter, 8 mm length) will be inserted under local anaesthesia into buccal alveolar bone between mandibular canine and first premolar roots on both sides with insertion angle of about 45° to 60° with alveolar process. A periapical radiograph will be taken beforehand to assure proper insertion without damaging neighbouring roots. Intermaxillary elastics will be applied between hooks and mandibular anterior mini‐implants, generating a 100 g force on each side of the jaw; in the first week (5/16 inch) followed by 3/16 medium size to generate an orthodontic force of about 200 g on each side until the end of treatment. Patients will be asked to wear elastics for 16 hours per day and replace elastics daily or when they get damaged. The patient or a parent will activate the expander twice daily (0.4 mm) until an overcorrection of maxillary constriction about 2‐3 mm is obtained. Patients in the two groups will be seen within one week, following the appliance’s first insertion, two weeks following the first insertion, and then at monthly visits to observe the change in incisor relationship, monitor patient's compliance by the researcher himself. Change in the incisor relationship from a negative overjet (i.e. + 1.5 mm or greater) will be considered the sign of successful treatment in the sagittal plane.  If the defect in the transverse plane is corrected before the one in the sagittal plane, the expansion will be stopped while the patient is asked to continue wearing the appliance until the defect in the sagittal plane is corrected and vice versa. The researcher will distribute the questionnaire to participants to fill in at five time points: 1) one day after beginning of treatment, 2) after one week, 3) after four weeks, 4) after three months, 5) after six months. Comparator treatment: removable mandibular retractor with slow maxillary expansion (RMR with SME) group (control) The appliance consists of: 1) upper acrylic plate with posterior bilateral bite plate, 2) reverse labial arch 0.9 mm of stainless steel, 3) Adam’s clasps on upper first permanent molars (0.7 mm stainless steel wire), 4) midline split incorporating one expansion screw, 5) anterior sagittal expansion screw will be used when there will be a need to correct the axes of the upper incisors. Patients will be asked to wear the RMR for 16 hours per day, including bedtime. The appliance will be activated monthly to adjust the anteroposterior location of the reverse arch to maintain passive (with light pressure) contact with cervical regions of lower anterior teeth. The patient or a parent will activate the expander twice weekly until an overcorrection of maxillary constriction about 2‐3 mm is achieved.  The duration of the procedure will be about 12 months including sagittal and transverse correction stage and retention stage.  This procedure will be carried out initially by the orthodontist and later by the participant or parent.  The participant/parent will activate the expander twice weekly until an overcorrection of maxillary constriction about 2‐3 mm is achieved. The participant will be monitored monthly to ensure compliance. The researcher will distribute the questionnaire to participants to fill in at five time points: 1) one day after beginning of treatment, 2) after one week, 3) after four weeks, 4) after three months, 5) after six months.
Outcomes	Primary Anteroposterior (sagittal) changes (lateral cephalogram). A panorama before the beginning of the treatment, lateral cephalogram, posterioanterior cephalogram will be taken for all participants at two time points: 1) before beginning of treatment, 2) at end of retention, i.e. after the total treatment period for the participant ‐ from the beginning of the x‐ray procedure until the end of the retention phase ‐ on average 12 months. Arch width (transverse) changes (posterioanterior cephalogram). Assessed at a single time point, 12 months after start of intervention Secondary Discomfort (4‐point scale: 1) none, 2) mild, 3) moderate, 4) severe). Assessed monthly until 12 months after start of intervention
Starting date	11 March 2022
Contact information	Principal investigator: Dr Ahmad Salim Zakaria, Orthodontic Unit, School of Dental Sciences, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia Email: ahmad_salem211@hotmail.com
Notes

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ISRCTN12197405.

Study name	An investigation of treating patients with conventional and skeletal anchored protraction headgear
Methods	The design will follow CONSORT guidelines. Routine orthodontic treatment protocols will be followed; thus, patients' pre‐treatment and post‐treatment lateral cephalogram radiographs will be evaluated to assess skeletal and dental effects of the appliances via assessing specific landmarks. Follow‐up two years after stopping treatment will assess stability of facemask therapy prior to starting fixed orthodontic appliance treatment.
Participants	Condition: Class III malocclusion; musculoskeletal diseases Inclusion criteria: skeletal Class III; healthy with no systemic diseases; age between 8 to 12 years; co‐operative children; good oral hygiene; true skeletal III without shift; all dentition present; healthy periodontium; no previous orthodontic treatment Setting: particupants will be recruited from the Orthodontic Department in the Department of Dental Surgery at Mater Dei Hospital, Malta
Interventions	Skeletal anchored device versus conventional facemask "The skeletal anchored device includes placing two mini‐implants in the palate of the patients then fabricating an orthodontic appliance that will set over them."
Outcomes	Primary Compliance rate of wearing protraction headgear assessed using a compliance sensor (Theramon) concealed in the facemask pad measured monthly over 9 months Secondary Skeletal and dental‐related outcomes measured with a cephalometric x‐ray at T0 before treatment and after treatment Quality of life assessed using the Child Perception Questionnaire (CPQ8‐11) before study start (baseline) then monthly for 9 months. "The lateral cephalogram will be analysed using specific angular and linear measurements. Lateral cephalograms will be traced by the same investigator to avoid inter‐examiner error; the same lateral cephalograms will be traced again to establish intraexaminer reliability. Furthermore, the interexaminer reliability test will be conducted to reduce any possible biases. Lateral cephalograms will be analysed by McNamara analysis to assess angular and linear changes. The same lateral cephalogram images will be used to assess patients' skeletal maturity using the CVM staging method. In addition, growth charts to assess the change in patients' height velocity will also be used. Using two indices to assess the patients' physical maturity will enhance the reliability of all patients being in the prepubertal stages."
Starting date	December 2019. End date: December 2022
Contact information	Dr Emad Eddin Alzoubi, emad.alzoubi@um.edu.mt
Notes

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ISRCTN93900866.

Study name	A clinical trial to assess the effectiveness of miniplate surgical treatment to bring the upper jaw forwards in 11‐14 years old children
Methods	Multicentre RCT
Participants	Participant inclusion criteria: age 11‐14 years; Class III skeletal pattern with reverse bite of at least 1 mm; dentally fit; written consent Participant exclusion criteria: cleft lip and or palate or craniofacial syndrome; reverse bite greater than 6 mm; lower jaw asymmetric; muscular dystrophy (weakness); smoker 57 participants recruited
Interventions	BAMP versus no treatment Group 1: BAMP surgery: small metal plates inserted from inside the mouth into the front part of the cheekbone bone next to the upper molars on each side. Further miniplates positioned into the bone down in the lower canine region near the front of the lower jaw. Elastics then attached from upper to lower plates, via hooks, to bring the upper jaw and teeth forwards and correct the class III skeletal pattern. Miniplates placed and later removed as a daycase general anaesthetic procedure and patient wears the elastics for around 6 to 8 months. Group 2: control/no treatment
Outcomes	Primary Need for orthognathic surgery later ‐ measured through consultant clinical panel consensus method using patient records Amount of forward movement of the maxilla (upper jaw) to correct the reverse bite ‐ measured from lateral cephalogram radiographs Reverse overjet (bite) correction ‐ measured from plaster study models of the patients’ teeth using a metal ruler Secondary Facial aesthetic improvement ‐ measured using panel consensus of facial profiles photographs Patient discomfort log following surgery ‐ recorded on a 7‐point Likert scale (1 = no pain at all to 7 = severe pain) Operating time for the BAMP surgery ‐ recorded from the theatre time log BAMP ‐ postoperative infection rates and plate failure rates ‐ recorded from patient notes Time points: baseline, 1 year, 3 years
Starting date	2 January 2015. End date: 1 October 2022
Contact information	Dr Nicola Mandall, Orthodontic Department, Tameside Hospital NHS Foundation Trust, Fountain Street, Ashton under Lyne, Lancashire, OL6 9RW, UK
Notes	Planned publication date: 1 October 2023

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NCT02711111.

Study name	Effect of bone‐anchored protraction on maxillary growth in the young child
Methods	RCT
Participants	20 participants Inclusion criteria: healthy children, 7 to 14 years old with Class III occlusion maxillary hypoplasia, good oral hygiene, no craniofacial syndrome
Interventions	Orthodontic bone anchor versus facemask Experimental: orthodontic bone anchor ‐ new bone anchor device, which creates anterior traction on the upper jaw. Placed on the chin region intra‐orally to apply force on the upper jaw (24/7) via intraoral elastics on the bone‐anchor (other name: mentoplate, PSM Medical Solutions, Tuttlingen, Germany) Control: conventional treatment method. Face mask creates anterior traction on the upper jaw. Force applied to the upper jaw (12 to 14 hours/day) via extra‐oral elastics to the face mask
Outcomes	Primary Maxillary growth in the young child, assessment of anterior growth of the upper jaw, with 3D analysis, 1 year after start of treatment Maxillary growth in the young child, assessment of anterior growth of the upper jaw, with 3D analysis, 5 years after start of treatment Secondary Registration of complications due to use of the new orthodontic bone anchor (mentoplate) (time frame: 1 year) Registration of patient satisfaction, easy to use (time frame: 1 year)
Starting date	April 2016
Contact information	Joeri Meyns, joerimeyns@outlook.com
Notes

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NCT03354442.

Study name	Evaluation of the efficacy of modified fixed mandibular retractor appliance in the treatment of Class III malocclusion: a clinical randomized controlled trial
Methods	Parallel RCT with outcome assessor blinding
Participants	44 participants Inclusion criteria: children in early mixed dentition (7‐9 years old); skeletal class III caused by mandibular prognathism with or without maxillary deficiency judged clinically and confirmed radiographically (ANB ≤ 1); anterior crossbite on two teeth or more; normal inclination of lower incisors with mandibular plane; good oral hygiene Exclusion criteria: poor oral hygiene; previous orthodontic treatment; patients with syndromes, clefts, or craniofacial abnormalities; severe skeletal class III resulting primarily from mandibular prognathism (ANB less than ‐ 4 with no functional shift on closure); facial asymmetry; vertical growth pattern
Interventions	Experimental: modified fixed mandibular retractor used full‐time Control: untreated. Observation to observe growth changes
Outcomes	Primary ANB angle changes Secondary SNA angle changes SNB angle changes Profile changes Upper incisor angle changes Lower incisor angle changes Angles will be measured before treatment and after obtaining 3 mm positive overjet, which will take approximately 8 months, using lateral cephalometric radiographs.
Starting date	15 May 2017. End date: 10 January 2019
Contact information	Ahmad Burhan, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Notes

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NCT04310267.

Study name	Dentoskeletal changes concomitant with different three levels of force application for maxillary protraction in growing orthodontic patients with Class 3 malocclusion
Methods	Parallel RCT with outcome assessor blinding
Participants	Target of 30 participants Inclusion criteria: 7 to 10 years of age; diagnosis of skeletal class 3 malocclusion due to retruded maxilla and/or combined maxillary retrusion with mild mandibular protrusion (based on cephalometric analysis); no serious systemic diseases and/or medical treatment that could interfere with orthodontic tooth movement, such as analgesics, non‐steroidal anti‐inflammatory drugs, and hormone supplements or antibiotics; good oral hygiene and periodontal condition; no evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunctions; no previous orthodontic or orthognathic treatment Exclusion criteria: systemic diseases or medications that could interfere with orthodontic treatment; poor oral hygiene or periodontally compromised patients; craniofacial anomalies or previous history of trauma, bruxism or parafunctions; previous orthodontic treatment. Setting: Al‐Azhar University, Cairo, Egypt
Interventions	Group 1: classic occlusal level, low point of force application. The point of force application for maxillary protraction is at the level of the occlusal plane. Group 2: nasal level, medium point of force application. The point of force application for maxillary protraction is at 20 mm from the occlusal plane (nasal floor). Group 3: infrorbital level, high level. The point of force application for maxillary protraction is at the level of the infraorbital foramen. Device: Petit‐type facemask (Intra‐oral) Hyrax expander for maxillary sutures disarticulation through expansion, (Extra‐oral) face mask for generating maxillary protraction forces and headgear face‐bow to act as a connector between both intra‐ and extra‐oral parts. Other name: Hyrax expander, headgear face‐bow (Denturum)
Outcomes	Primary Amount of maxillary advancement ‐ increase in maxillary length (condalyon‐A point) in mm, using CBCT Secondary Degree of maxillary rotation ‐ change in maxillary inclination (occlusal plane to SN line) in degrees, using CBCT Time frame: 8 months
Starting date	5 September 2018
Contact information	Khaled Taha, kh.taha@azhar.edu.eg
Notes	May not have an outcome of interest

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NCT04387175.

Study name	Comparison between an intraoral device and facial mask for the early treatment of Class III malocclusion: a randomized controlled trial
Methods	Unknown
Participants	Inclusion criteria: aged between 5 and 8 years; prepubertal (cervical vertebral stage 1 or 2); deciduous, early mixed, and intermediate mixed dentition (lower deciduous canine should show at least 2/3 of roots unresorbed); presence of Class III skeletal imbalance (Wits appraisal equal to or smaller than 1 mm) Exclusion criteria: early root resorption of the lower deciduous canines; periodontal disease; neurologic diseases; nickel allergy; cleft lip and palate or craniofacial syndromes; irradiated in head and neck area; having undergone chemotherapy or immunosuppressive therapy in the previous 5 years; unable to be followed up for at least 1 year Study setting: Azienda Ospedaliero‐Universitaria Careggi, Florence, Italy
Interventions	Experimental: Carriere Motion 3D Class III Appliance. The device made of stainless steel consists of a flexible bar with two pads at the end, which are bonded bilaterally with composite resin to the lower second deciduous molar or the lower first permanent molar at the rear and the lower deciduous canine at the front. The base on the lower deciduous canine has a hook to which bilaterally elastic latex bands are connected with the vestibular tubes of the cemented bands on the upper deciduous second molars (Force 2 elastics) or on the first permanent upper molars (Force 1 elastics), on whose palatine surface a rapid maxillary expander is welded. Control: facial mask. The facial mask consists of a chin pad and frontal pad connected by a central steel bar. On the central bar there is a horizontal steel bar to which latex elastic bands are attached, which develop 14 ounces of force. The elastics are connected to the rapid maxillary expander by means of two hooks welded on the bands of the second upper deciduous molars or the first upper permanent molars.
Outcomes	Primary outcome: Wits appraisal (change in Wits appraisal evaluated on lateral cephalograms taken at the start and end of active treatment (6 to 10 months)). Distance between perpendiculars from points A and B on the maxilla and mandible, respectively, onto the occlusal plane.
Starting date	Unknown
Contact information	Lorenzo Franchi
Notes

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NCT04825951.

Study name	Three dimensional evaluation of dentofacial effects of two non‐compliance appliances in the treatment of growing skeletal Class III patients (a randomized controlled clinical trial)
Methods	3‐arm parallel RCT
Participants	Number recruited: 33 growing skeletal Class III patients (9 to 11 years) Eligible for study: ages 8 to 12 Inclusion criteria Age range from 9 to 11 years Cervical Vertebrae Maturation Index (CVMI 2 and 3) identified on the lateral cephalometric radiograph Angle Class III molar relation Skeletal class III ANB ranges between 0 and ‐4 Wits appraisal ranges between 0 and ‐5 Good oral hygiene and healthy periodontal condition Reversed overjet between ‐1 and ‐6 Normal vertical growth pattern (SN‐MP angle 28˚ to 38˚) Exclusion criteria Discrepancy between centric relation and maximum intercuspation Previous orthodontic treatment Currently receiving drug therapy that may affect orthodontic tooth movement Congenitally missing teeth or extracted teeth History of systemic disease or craniofacial syndromes or presence of cleft Setting: Alexandria University
Interventions	People fulfilling the inclusion criteria will be randomly assigned using a computer‐generated list to one of the three groups, with a 1:1:1 allocation ratio. Group I: 11 treated with CS2000 appliance Group II: 11 treated with reversed Forsus Fatigue Resistant device Group III: control group of 11 untreated participants
Outcomes	A CBCT will be made before installing the appliances. After gaining a 2 mm positive overjet or a 6‐month period, alginate impressions will be poured and dental casts will be made. Photographs and CBCTs will also be performed to record the dentofacial effect of the appliances used. Primary 1. Skeletal readings (angles): SNA, SNB, ANB, SN‐MP (degrees) 2. Skeletal readings in percentages: LAFH % 3. Skeletal readings: Wits appraisal (mm) 4. Dental readings (angles): various 5. Dental readings: various 6. Soft tissue readings: various Secondary 1. Changes in airway: difference in airway volume (mm³) 2. Changes in TMJ: anterior, posterior, superior and medial joint space (mm³) Time frame for all outcomes: 6 months
Starting date	1 April 2021 (estimated)
Contact information	Tarek N Yousry, Lecturer, tarek.yousry@gmail.com Principal Investigator: Bassant A Abbas, PhD resident, Alexandria University
Notes	Alexandria University Faculty of Dentistry, Alexandria, Egypt

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NCT04863404.

Study name	Evaluation of the treatment effects of tooth‐borne versus bone‐anchored protraction procedures in Class III patients with maxillary deficiency
Methods	3‐arm parallel RCT
Participants	Number recruited: 42 participants Mean age: ages eligible for study: 10 to 13 years Inclusion criteria Late mixed or early permanent dentition C3 or C4 period according to the cervical vertebral maturation method Presence of skeletal class III malocclusion (ANB < 0°) Retrusive nasomaxillary complex (Nperp‐A < 1 mm) Presence of dental class III malocclusion Normal or horizontal growth pattern (SNGoGn < 40°) Negative overjet (overjet < 0) Good co‐operation Absence of any systemic disease Periodontal health No previous orthodontic treatment No craniofacial deformity No neuromuscular deformity Absence of a congenital anomaly Exclusion criteria Poor co‐operation Early mixed dentition Individuals who have passed the C4 period Craniofacial deformity Congenital anomaly History of facial trauma syndromes such as cleft lip and palate Setting: Izmir Katip Celebi University, Faculty of Dentistry, Department of Orthodontics, İzmir, Çiğli, Turkey
Interventions	Experimental: bone‐anchored maxillary protraction group, face mask with hybrid‐hyrax Experimental: tooth‐borne maxillary protraction group, face mask with conventional bonded RME No intervention: control group consisting of 14 people with non‐treated Class III malocclusion
Outcomes	Primary Pre‐treatment cephalometric analysis measures. A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions Pre‐treatment soft tissues measurements. Maxillary and mandibular (soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry Secondary Post‐treatment cephalometric analysis measurements (time frame average of 6 months). Evaluation of post‐treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions Post‐treatment soft tissues measurements (time frame average of 6 months). Evaluation of maxillary and mandibular soft tissue changes (soft tissue convexity angle) using 3D stereophotogrammetry
Starting date	15 June 2020
Contact information	Burcin Akan, Burcin.yksel@gmail.com
Notes

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NCT04911400.

Study name	Effects of Class III elastics on stability of orthopaedic Class III correction
Methods	Allocation: randomised Intervention model: parallel assignment Masking: single (outcomes assessor) Primary purpose: prevention
Participants	Age: 12 to 16 years Inclusion criteria Patients who completed their orthodontic treatment of their skeletal class III with upper jaw retrusion with Class III orthopaedic appliances, followed by full fixed appliances No congenital anomalies or craniofacial syndromes No other orthodontic treatment No medical history that affects growth Exclusion criteria Congenital anomalies or craniofacial syndromes Other orthodontic treatment Medical history that affects growth
Interventions	Active: upper‐lower clear plastic retainers + Class III elastics Control: upper‐lower clear plastic retainers
Outcomes	Primary Overjet Secondary Need for jaw surgery ‐ assessed by a panel of orthodontists Difference in upper jaw position ‐ SNA angle measured on cephalometric radiographs Difference in lower jaw position ‐ SNB angle measured on cephalometric radiographs Difference in upper‐lower jaw relationship ‐ ANB angle measured on cephalometric radiographs Difference in upper incisor angulation ‐ upper incisor angle measured on cephalometric radiographs Difference in lower incisor angulation ‐ lower incisor angle measured on cephalometric radiographs Compliance and ease of use of both retention regimens ‐ measured using questionnaire on frequency and ease of use Effect of elastics on alignment retention ‐ measured by Little's Irregularity Index Periodontal health, including recession around the incisors ‐ presence of gingival recession and prominence of lower incisors Time frame for measuring outcomes: 5 years
Starting date	22 July 2020
Contact information	Principal investigator: Oyku Dalci, Sydney Local Health District, The University of Sydney, Australia
Notes

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NCT05089396.

Study name	Assessment of dentoskeletal effects concomitant with skeletally anchored maxillary protraction in orthodontic skeletal Class III patients
Methods	2‐arm parallel RCT
Participants	Number recruited: 14 estimated Mean age: eligible for study: 8 to 14 years Inclusion criteria Growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method Skeletal Class III malocclusion with maxillary deficiency (ANB < 0°; N perp‐A < 1 mm) with or without mild mandibular prognathism Late mixed or early permanent dentition at the start of treatment characterised by a Wits appraisal of ‐1 mm or less and an Angle Class III molar relationship or anterior crossbite Vertically normal growth pattern determined by cephalometric radiographs Free from developmental or congenital conditions such as cleft lip/palate or other craniofacial anomalies No previous orthodontic treatment Exclusion criteria Poor oral hygiene or periodontally compromised Craniofacial anomalies or previous history of trauma, bruxism, or parafunctions Previous orthodontic treatment Setting: Al‐azhar University ‐ Faculty of Dental Medicine, Cairo, Egypt
Interventions	Experimental: skeletally anchored maxillary protraction. A Petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in addition, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. A force of 380 g to 400 g will be applied through the extraoral elastics then will be attached to the facemask on one side and to the facemask splint on the other side. Active comparator: conventional dentally anchored maxillary protraction. A Petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch). a force of 380 g to 400 g will be applied through the extra‐oral elastics then will be attached to the facemask on one side and to the facemask splint on the other side. A Petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in the active comparator group. in the experimental group, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. In both groups, a force of 380 g to 400 g will be applied through the extraoral elastics then will be attached to the facemask on one side and to the facemask splint on the other side. Other: maxillary protraction A Petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in the active comparator group. In the experimental group, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. In both groups, a force of 380 g to 400 g will be applied through the extraoral elastics then will be attached to the facemask on one side and to the facemask splint on the other side.
Outcomes	Primary: midfacial length linear distance between condylon and A points Time frame: 1 year
Starting date	22 November 2021
Contact information	Contacts: Amr Embaby, amrembaby.209@azhar.edu.eg; Farouk Husssein, Professor and Chairman, dr.farokahmed@azhar.edu.eg
Notes	May not have an outcome of interest

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NCT05345756.

Study name	Intra‐oral maxillary protraction technique vs facemask using Alt‐RAMEC protocol for treatment Class III growing patients (ALT‐RAMEC)
Methods	Allocation: randomised Intervention model: parallel assignment Masking: single (participant) Primary purpose: treatment
Participants	Age: 9 to 13 years (child) Inclusion criteria Male or female growing patient (CVM2‐CVM3) Skeletal class III (ANB ≤ 0, A‐NV≤ ‐2 and Wits appraisal < ‐0.3 mm) Erupted upper and lower first permanent molars and permanent incisors Reverse overjet up to ‐4 mm Exclusion criteria History of previous orthodontic treatment Cleft lip/palate Habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting) Syndromes
Interventions	Group 1: intra‐oral protraction device ‐ use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT‐RAMEC protocol Group 2: extra‐oral protraction device ‐ facemask, which is an extra‐oral appliance used for maxillary protraction
Outcomes	Primary Maxillary skeletal changes using lateral cephalometric x‐ray to measure maxillary skeletal changes using angular measurements in degrees (SNA) Secondary Mandibular skeletal changes using lateral cephalometric x‐ray to measure mandibular skeletal changes using angular measurements in degrees (SNB) Maxillary and mandibular dental changes using lateral cephalometric x‐ray to measure changes using angular measurements in degrees (U1/palatal plane, L1/mandibular plane) Outcomes measured at 8 months
Starting date	1 May 2022
Contact information	Andrew Demian, Cairo University, androwafdy@gmail.com
Notes

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NCT05475548.

Study name	Effect of skeletally anchored reversed PowerScope appliance in orthodontic treatment of patients with Class III malocclusion
Methods	Interventional (clinical trial) Estimated enrolment: 16 participants Allocation: randomised Intervention model: factorial assignment
Participants	Inclusion criteria: both males and females,mild to moderate Class III malocclusion adolescent patients with ANB (‐3 to 0); all permanent teeth are erupted (3rd molar not included); age 14 to 18 years; good oral and general health; no systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement; no previous orthodontic treatment Exclusion criteria: orthodontic cases with severe crowding of upper and lower anterior segment that require extraction treatment approach; patients with a blocked‐out tooth that will not allow for placement of the bracket at the initial bonding appointment
Interventions	Group A: reversed skeletally anchored PowerScope ‐ 8 participants will be treated by preadjusted straight wire appliance followed by reversed skeletally anchored PowerScope as a fixed functional appliance. Group B: dentally anchored reversed PowerScope ‐ 8 participants will be treated by preadjusted straight wire appliance followed by dentally anchored reversed PowerScope as a fixed functional appliance.
Outcomes	Primary Dentoskeletal change Soft tissue change Measured by cephalometric parameters Time frame: 1.5 years
Starting date	December 2022
Contact information	Ahmed Mohamed Sallam, Al‐Azhar University, Egypt
Notes	Participants may be too old as inclusion age 14 to 18 years

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ALT‐RAMEC: alternate rapid maxillary expansion and constriction; ANB: A point, nasion, B point ‐ angle between maxilla and mandible; A‐Np: A‐point to nasion perpendicular distance; BAIMT: bone‐anchored intermaxillary traction; BAMP: bone‐anchored maxillary protraction; C3: 3rd cervical vertebrae; C4: 4th cervical vertebrae; CBCT: cone beam computed tomography; CONSORT: Consolidated Standards of Reporting Trials; CVM: cervical vertebral maturation; g: grams; L1: lower incisor; LAFH: lower anterior facial height; N perp‐A: same as A‐Np: A‐point to nasion perpendicular; mm: millimetre; MM: maxillary‐mandibular plane; RCT: randomised controlled trial; RME: rapid maxillary expander (or expansion); RMR: removable mandibular retractor; SME: slow maxillary expansion; SNA: angle between sella‐nasion plane and nasion‐A plane; SNB: angle between sella, nasion and supramentale point B; SNGoGn: angle between sella‐nasion and mandibular plane; SN‐MP: angle between sella‐nasion to mandibular plane; T: time point (e.g. T0 = baseline assessment time point); 3D: three‐dimensional; TMJ: temporomandibular joint; vs: versus; U1: upper incisor

Differences between protocol and review

We added a long‐term outcome in the 2024 review update: surgery in adulthood.

We moved the secondary outcome 'jaw joint problems' to include it under 'adverse effects'.

Contributions of authors

The 2024 review was co‐ordinated by Jayne Harrison (JH) and Darren Owens (DO). DO undertook the handsearching. JH, DO and Sarah Turner (ST) screened the search results and retrieved papers, appraised the risk of bias in the papers and extracted data from them. DO checked the data extraction. DO, Helen Worthington (HW) and JH analysed and interpreted the data and wrote the review. Simon Watkinson (SW) acted as arbiter for study selection.

The 2013 review was co‐ordinated by JH and SW. SW undertook the handsearching. SW, JH and Sue Furness (SF) screened the search results and retrieved papers, appraised the quality of the papers and extracted data from them. SF checked the data extraction. SF and HW analysed and interpreted the data. SW, SF, HW and JH wrote the review.

Sources of support

Internal sources

The Liverpool University Hospitals NHS Foundation Trust, UK

JH employer
School of Dentistry, The University of Manchester, UK

Cochrane Oral Health is hosted by The University of Manchester
Manchester Academic Health Sciences Centre (MAHSC), UK

Cochrane Oral Health is supported by MAHSC and the NIHR Manchester Biomedical Research Centre

External sources

NHS National Primary Dental Care R&D programme, UK

PDC 97‐303. Funding was used for the pilot project and early handsearching.
Cochrane Oral Health Global Alliance, UK

The production of Cochrane Oral Health reviews has been supported financially by our Global Alliance since 2011 (oralhealth.cochrane.org/partnerships-alliances). Contributors in the past few years have been the American Association of Public Health Dentistry, USA; AS‐Akademie, Germany; the British Association for the Study of Community Dentistry, UK; the British Society of Paediatric Dentistry, UK; the Canadian Dental Hygienists Association, Canada; the Centre for Dental Education and Research at All India Institute of Medical Sciences, India; the National Center for Dental Hygiene Research & Practice, USA; New York University College of Dentistry, USA; and Swiss Society of Endodontology, Switzerland.
National Institute for Health Research (NIHR), UK

This project was supported by the NIHR, via Cochrane Infrastructure funding to Cochrane Oral Health. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Evidence Synthesis Programme, the NIHR, the NHS or the Department of Health and Social Care.

Declarations of interest

Darren J Owens: no interests to declare. Simon Watkinson: no interests to declare. Jayne E Harrison: I am an Editor with Cochrane Oral Health, but I was not involved in the editorial processing of this review update. No interests to declare. Sarah Turner: no interests to declare. Helen V Worthington: I am an Editor with Cochrane Oral Health and was formerly a Co‐ordinating Editor running the group, but I was not involved in the editorial processing of this review update. No interests to declare.

New search for studies and content updated (conclusions changed)

References

References to studies included in this review

Abdelnaby 2010 {published data only}

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Showkatbakhsh 2012 {published data only}

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Pavoni 2009 {published data only}

Pavoni C, Mucedero M, Baccetti T, Franchi L, Polimeni A, Cozza P. The effects of facial mask/bite block therapy with or without rapid palatal expansion. Progress in Orthodontics 2009;10(1):20-8. [PubMed] [Google Scholar]

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Saleh 2013 {published data only}

Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the removable mandibular retractor appliance. European Journal of Paediatric Dentistry 2013;14:119-24. [PubMed] [Google Scholar]
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PERMALINK

Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children

Darren Owens

Simon Watkinson

Jayne E Harrison

Sarah Turner

Helen V Worthington

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings 1. Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children.

Summary of findings 2. Surgical orthodontic treatment versus no treatment for prominent lower front teeth in children.

Summary of findings 3. Facemask therapy versus other non‐surgical orthodontic treatment for prominent lower front teeth in children.

Summary of findings 4. Facemask therapy versus surgical orthodontic treatment for prominent lower front teeth in children.

Summary of findings 5. Facemask variations for prominent lower front teeth in children.

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Summary of findings and assessment of the certainty of the evidence

Results

Description of studies

Results of the search

1.

Included studies

Characteristics of the study setting and investigators

Characteristics of the participants

Characteristics of the interventions

Non‐surgical orthodontic treatments

Facemask therapy

Other non‐surgical interventions

Surgically‐anchored appliances

Comparisons

Characteristics of the outcomes

Primary outcome

Prominence of lower front teeth

Secondary outcomes

Relationship between the upper and lower jaw

Psychosocial measures

Patient satisfaction

Surgery in adulthood

Adverse effects

Excluded studies

Risk of bias in included studies

2.

3.

Allocation

Sequence generation