Jamilian 2011.
Methods | Location: University of Islamic Azad and Shahid Beheshti, Tehran, Iran Number of centres: not specified Recruitment period: not stated Funding source: not stated Trial design: parallel group RCT |
|
Participants | Inclusion criteria: ANB > 4°, SNB < 78° degrees, overjet ≥ 5 mm at the start of treatment, no syndromic or medically compromised patients, no previous surgical intervention, no use of other appliances before or during the period of functional treatment, a normal mandibular growth pattern: neither horizontal nor vertical, no skeletal asymmetry Age at baseline: R‐appliance group 10.5 (SD 0.7) years and Twin Block group 11.3 (SD 1.3) years Number randomised: 55 Number evaluated: 55 (no dropouts) |
|
Interventions | Gp A (n = 30): R‐appliance ‒ Tooth‐ and tissue‐born functional appliance worn full time Gp B (n = 25): Twin Block appliance with upper labial bow worn full time |
|
Outcomes | Skeletal measurements from cephalograms, occlusal changes | |
Notes | Duration of randomised treatment: R‐appliance 16.2 months (SD 0.3) months, Twin Block appliance 16.1 (SD 1.4) months Sample size calculation: not specified |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised. "...patients were randomly divided to two groups using random number tables" (unpublished data) |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not clearly described. "Specific codes were assigned to each patient for their concealment" (unpublished data) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded (unpublished data). However, the method of blinding was not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Low risk | All variables reported |
Other bias | Low risk | No other bias detected |