Methods |
Trial design: single‐centre RCT (parallel group)
Location: Department of Orthodontics, School of Stomatology, Tongii University, Shanghai, China
Recruitment period: not stated
Funding source: not stated
Source of participants: patients attending clinic
Study duration: not stated
Time points at which follow‐up are reported: before and after active orthodontic treatment
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Participants |
34 participants in total (28 female, 6 male), mean age 20.68 years
17 in mini‐screw implant group: mean age 21.65 years ± 4.49; 3 males, 14 females
17 in the transpalatal arch group: mean age 19.71 years ± 3.06; 3 males, 14 females
bi‐alveolar dental protrusion presenting as Class I or Class II division I malocclusion
no patients less than 18 years old
no previous orthodontic treatment
all 4 first premolars extracted
maximum anchorage required
agree to have mini‐screw implant and transpalatal arch placed
no congenitally missing teeth except for the third molars
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Interventions |
Self tapping titanium mini‐screw implants
1.2 mm diameter, 8 mm length
Placed between roots of the maxillary second premolar and first molar
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Outcomes |
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote: "they were randomly assigned to two groups with the aid of a table of random numbers" |
Allocation concealment (selection bias) |
Unclear risk |
The method of allocation concealment was not mentioned |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not addressed |
Incomplete outcome data (attrition bias)
mesial movement of upper first maxillary molar |
Low risk |
All randomised patients were included in the analysis |
Selective reporting (reporting bias) |
Unclear risk |
|
Other bias |
Low risk |
Study appears to be free of other sources of bias |