TABLE 4.
Summary of findings of the randomized controlled trials with quality of evidence assessment
| Randomized controlled trials | |||||
|---|---|---|---|---|---|
| Outcome | Subjects, N (studies) | RR or SMD (95% CI) | Tit. event proportion | Bio. risk (95% CI) | Quality of evidence (GRADE) |
| Perioperative endpoints | |||||
| Plate breakage a | 482 (4) | Four studies, of which two had zero events, one assessed plate breakage at plate level, and one at patient level | |||
| Screw breakage a | 348 (4) | Four studies, of which two had zero events, one assessed screw breakage at screw level, and one at patient level | |||
| Operation time b | 266 (2) | +0.50 (0.09; 0.91) | NA | NA | Moderate c |
| Handling by surgeon b | 260 (2) | Two studies, different outcome measures | |||
| Short‐term follow‐up | |||||
| Malocclusion a | No studies | ||||
| Infection a | 645 (8) | 1.03 (0.46; 2.28) | 43 per 1000 | 45 per 1000 (20; 98) | Moderate f |
| Swelling a | 255 (2) | 1.51 (0.68; 3.38) | 133 per 1000 | 201 per 1000 (91; 450) | Very low c , d , f |
| Abscess a | 200 (1) | Single study | |||
| Pain a | 160 (3) | Three studies, two with different outcome measures and one provided data in graphs only | |||
| Analgesics used a | No studies | ||||
| MMO b | 66 (1) | Single study that provided data in graphs only | |||
| Dehiscence a | 421 (5) | 1.53 (0.52; 4.50) | 24 per 1000 | 37 per 1000 (13; 108) | Moderate f |
| Plate exposure a | 182 (4) | Four studies, of which two had zero events and one did not provide sufficient details | |||
| Intermediate follow‐up | |||||
| Malunion a | 240 (2) | Two studies, of which one had zero events | |||
| Mobility bone segments a | 115 (2) | 1.37 (0.47; 3.99) | 104 per 1000 | 143 per 1000 (49; 415) | Moderate f |
| Malocclusion a | 200 (1) | Single study | |||
| Pain b | 260 (2) | −0.01 (−0.26; 0.24) | NA | NA | Moderate c |
| MMO b | 66 (1) | Single study that provided data in graphs only | |||
| TMJ‐dysfunction a | 22 (1) | Single zero‐event study | |||
| Long‐term follow‐up | |||||
| Malocclusion a | 217 (3) | 0.93 (0.39; 2.26) | 113 per 1000 | 105 per 1000 (44; 256) | Moderate f |
| Pain b | 220 (3) | −0.02 (−0.29; 0.25) | NA | NA | High |
| MMO b | 141 (2) | −0.58 (−1.39; 0.22) | NA | NA | Very low c , e , f |
| TMJ‐dysfunction a | 40 (1) | Single study | |||
| MFIQ b | 203 (1) | Single study | |||
| Abscess a | 203 (1) | Single study | |||
| Swelling a | 178 (2) | 2.42 (0.52; 11.19) | 20 per 1000 | 49 per 1000 (11; 224) | Moderate c , f , g |
| Palpability plate/screws a | 400 (4) | 0.38 (0.11; 1.28) | 232 per 1000 | 89 per 1000 (26; 297) | Very low c , d , f |
| Satisfaction b | 329 (3) | Three studies, different outcome measures | |||
| Overall follow‐up | |||||
| Symptomatic device removal a | 777 (7) | 1.29 (0.68; 2.44) | 83 per 1000 | 107 per 1000 (57; 203) | Moderate4 |
| Total costs b | 203 (1) | Single study | |||
| Revision surgery (not device removal) a | 377 (4) | 1.40 (0.37; 5.34) | 20 per 1000 | 28 per 1000 (8; 107) | Moderate4 |
| Maxillary horizontal relapse (adv) | 160 (3) | Three studies, of which one provided data in graphs only and one could not be included in the meta‐analysis due to zero variance in the titanium group | |||
| Maxillary angular relapse (adv) | 100 (2) | Two studies, significant different reference points used for assessment | |||
| Maxillary horizontal relapse (sb) | No studies | ||||
| Maxillary angle relapse (sb) | No studies | ||||
| Maxillary vertical relapse (imp) | 95 (2) | +0.07 (−0.35; 0.50) | NA | NA | High |
| Maxillary vertical relapse (elong) | 60 (1) | Single study | |||
| Mandibular horizontal relapse (adv) | 80 (2) | Two studies, of which one provided data in median with interquartile range and one provided insufficient details | |||
| Mandibular horizontal relapse (sb) | 80 (2) | +0.04 (−0.73; 0.80) | NA | NA | Low d , f |
| Mandibular vertical relapse (adv) | 80 (2) | Two studies, of which one provided data in median with interquartile range and one provided insufficient details | |||
| Mandibular vertical relapse (sb) | 80 (2) | −0.63 (−1.11; −0.15) | NA | NA | Low d , f |
| Mandibular angular relapse (CW) | 22 (1) | Single study | |||
| Mandibular angular relapse (CCW) | 80 (2) | 1.12 (0.08; 2.16) | NA | NA | Very low d , e , f |
Abbreviations: adv, advancement; Bio, biodegradable osteosynthesis; CCW, counter clockwise rotation; CW, clockwise rotation; elong, elongation; GRADE, Grades of Recommendation, Assessment, Development and Evaluation Working Group system; NA, not applicable; RR, risk ratio (binary variables); sb, setback; imp, impaction; SMD, standardized mean difference (continuous variables); Tit, titanium osteosynthesis.
Binary variable.
Continuous variable.
Downgraded one level due to high risks of bias identified across studies: majority of studies had high risk of bias.
Downgraded one level for inconsistency: substantial methodological or clinical heterogeneity that could not be accounted for in analyses.
Downgraded one level for indirectness: the evidence of the original manuscripts were more restrictive than the review question.
Downgraded one level for imprecision: limits of effect estimate confidence interval are not consistent (i.e., cover both benefit and harm).
Upgraded one level due to large effect (i.e., RR < 0.5 or RR > 2.0, or SMD < −0.8 or SMD > +0.8).