Showkatbakhsh 2011.
Methods | Location: Tehran, Iran Number of centres: not specified Recruitment period: not stated Funding source: not stated Trial design: parallel group RCT |
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Participants | Inclusion criteria: ANB > 4°, SNB < 78°, overjet > 5 mm in the initial lateral cephalogram. No syndromic or medically compromised patients, no surgical intervention, no use of other appliances before or during the period of functional treatment, normal growth pattern of the mandible (MP‐SN), symmetric relationship between maxilla and mandible Exclusion criteria: not stated Age at baseline: R‐appliance mean age 10.4 (SD 0.8). Anterior Inclined Bite Plate (AIBP) 9 (SD 1.2) years Number randomised: 50 randomised, 50 started treatment Number evaluated: 50 at the end of functional phase (no dropouts) (unpublished data) |
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Interventions | Gp A (n = 25): R‐appliance Gp B (n = 25): Anterior Inclined Bite Plate (AIBP) |
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Outcomes | Skeletal growth changes; maxilla, mandible, skeletal relationship reported. Dental measurements were not reported | |
Notes | Duration of intervention: Gp A (R‐appliance): 11 (SD 2) months. Gp B: 9 (SD 1.2) months Sample size calculation: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to two groups using standardised random number table" |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Unclear risk | Only skeletal measurements reported. No linear dental measurements reported |
Other bias | Low risk | No other bias detected |