Elkordy 2016.

Methods	Location: Cairo, Egypt Number of centres: 1 Recruitment period: from June 2012 to December 2013 Funding source: self‐funded by the authors Trial design: parallel group RCT
Participants	Inclusion criteria: females 11 to 14 years old; skeletal angle Class II division 1 malocclusion with a deficient mandible (SNB ≤ 76°); horizontal or neutral growth pattern (MMP ≤ 30°); increased overjet (minimum 5 mm) with Class II canine relationship (minimum of half unit); erupted full set of permanent teeth with mandibular arch crowding less than 3 mm; at the time of insertion of the FFRD, the patients had to be in the MP3 G or MP3 H stage according to Rajagopal Exclusion criteria: systemic disease; any signs or symptoms of temporomandibular dysfunction; extracted or missing permanent tooth/teeth; facial asymmetry; parafunctional habits; severe proclination or crowding that requires extractions in the lower arch Age at baseline: FFRD ‒ 16 females (13.25 SD 1.12); FMI ‒ 15 females (13.07 SD 1.41); control (12.71 SD 1.44) Number randomised: 46 Number evaluated: 43
Interventions	Gp A (n = 16/16): Forsus Fatigue Resistance Device (FFRD) Gp B (n = 15/15): Forsus Fatigue Resistance Device with mini‐implant (FMI) Gp C (n = 15/12): control/no intervention
Outcomes	(i) Overjet (ii) Skeletal changes (iii) Dentoalveolar changes (iv) Patient satisfaction
Notes	Duration of randomised treatment: FFRD ‒ 4.86 (SD 1.32) FMI ‒ 5.34 (SD 1.29) Sample size calculation: sample size calculation was done using G power software (Universität Düsseldorf, Düsseldorf, Germany), with an alpha value of 0.05 and a power of 80% based on the study by Weschler and Pancherz and revealed the need for 12 participants per group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"A computer‐generated random list was created (https://www.random.org/)....The patients were randomly allocated into three groups..." The control group arm was not reported in the first part of the study.
Allocation concealment (selection bias)	Low risk	"...and allocation concealment was achieved with opaque sealed envelopes."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The assessors were blinded during the analysis."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Gp A ‐ Forsus Fatigue Resistance Device (FFRD) recruited 16, analysed 16 (loss 0%) Gp B ‐ Forsus Fatigue Resistance Device with mini‐implant (FMI) recruited 15, analysed 15 (loss 0%) Gp C ‐ control/no intervention recruited 15, analysed 12 (loss 20%) Reasons for discontinuation in control group: "Two of the control patients wanted to start treatment immediately, and a third could not be reached after 3 months"
Selective reporting (reporting bias)	Low risk	All variables reported
Other bias	Unclear risk	The sample comprised 32 females.