The use of the Hanks Herbst vs Twin-block in Class II malocclusion: A randomized controlled trial.

INTRODUCTION: This 2-arm parallel study aimed to compare and evaluate the efficiency of Hanks Herbst (HH) and Twin-block (TB) functional appliances in treating adolescents with Class II malocclusion. METHODS: A parallel-group randomized controlled trial was undertaken in a single United Kingdom hospital. Eighty participants were recruited and randomized in a 1:1 ratio to receive either the HH or TB appliance. Eligibility criteria included children aged 10-14 years with an overjet of >/=7 mm without dental anomalies. The primary outcome was the time (in months) required to reduce overjet to normal limits (<4 mm). Secondary outcomes included treatment failure rates, complications and their impact on oral health-related quality of life (OHRQOL). Randomization was accomplished using electronic software with allocation concealed using sequentially numbered, opaque, and sealed envelopes. Blinding was only applicable for outcome assessment. Data were analyzed using descriptive statistics and regression analyses to detect between-group differences, including Cox regression for time to treatment success. RESULTS: HH was significantly faster than TB in reducing the overjet to within normal limits (95% confidence interval [CI], -3.00 to -0.03; P = 0.046). Mean overjet reduction was more efficient with the HH than the TB appliance (ss = 1.3; 95% CI, 0.04-2.40; P = 0.04). Fifteen (37.5%) of the participants in the TB group and 7 (17.5%) in the HH group failed to complete the treatment (hazard ratio = 0.54; 95% CI, 0.32-0.91, P = 0.02). However, TB was associated with fewer routine (incidence rate ratio = 0.81; 95% CI, 0.7-0.9; P = 0.004) and emergency (incidence rate ratio = 0.1; 95% CI, 0.1-0.3; P = 0.001) visits. Chairside time was greater with the HH (ss = 2.7; 95% CI, 1.8-3.6, P = 0.001). Participants in both groups experienced complications with similar frequency. A greater deterioration in OHRQOL was found during treatment with the TB. CONCLUSIONS: Treatment with HH resulted in more efficient and predictable overjet reduction than TB. More treatment discontinuation and greater deterioration in OHRQOL were observed with the TB. However, HH was associated with more routine and emergency visits. REGISTRATION: ISRCTN11717011. PROTOCOL: The protocol was not published before trial commencement. FUNDING: No specific external or internal funding was provided. Treatment for participants was provided as part of routine orthodontic treatment in the hospital.