Aras 2017a.
| Methods | Location: Turkey Number of centres: 1 Recruitment period: not stated Funding source: not stated Trial design: parallel group RCT |
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| Participants | Inclusion criteria: angle Class II Division 1 malocclusion in the permanent dentition with an overjet greater than 6 mm and full‐cusp Cl II molar relationship; ANB greater than 48 with retrognathic mandible; mild or no crowding; growth period just before or at the peak of pubertal growth (evaluated by hand‐wrist radiographs); and SN‐GoGn not exceeding 388 Exclusion criteria: none stated Age at baseline: Gp 1: 13.48 years (SD 0.88); Gp 2: 13.15 years (SD 0.77); Gp 3: 13.76 years (SD 0.62) Number randomised: 36 (18 in each group) Number evaluated: 34 (2 dropouts) |
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| Interventions | Gp 1 (n = 17): FMA using stepwise mandibular advancement (SWG) Gp 2 (n = 17): FMA using single‐step advancement (SSG) |
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| Outcomes | Cephalometric radiographs to assess soft tissues and dentoskeletal effects | |
| Notes | Sample size: "the power analysis with 0.05 level and 80% power (based on a 0.62‐mm standard deviation and a 0.6‐mm detectable difference), the needed minimum sample size was 17 for each group" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Matched randomization was used for assigning patients to study groups. Subjects were divided into 18 pairs using matched randomization based on sex and a similar degree of malocclusion (considering SNB, ANB, SNGoGn, and overjet). One patient of each pair, selected at random by tossing a coin, was treated with FMA utilizing stepwise advancement, while the mandible of the other patient was progressed in a single step." |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Cephalometric measurements were performed in a blinded manner, i.e., the examiner (A.P.) was unaware of the group assignment." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Gp 1: recruited 18, analysed 17 Gp 2: recruited 18, analysed 17 "Because a male patient in the SSG discontinued treatment, the corresponding patient in the other group was excluded from the final analysis to maintain a 1:1 intergroup ratio. Data for 34 subjects were collected." |
| Selective reporting (reporting bias) | Low risk | Expected outcomes reported |
| Other bias | Low risk | No other sources of bias identified |