Headgear therapy in children with Class II malocclusion and the role of compliance on treatment outcome: A nine-month randomized controlled trial.

OBJECTIVES:To evaluate three-dimensional movements of maxillary teeth during headgear treatment in Class II growing children, using digital analytical tools, and to determine the effects of compliance on these movements. MATERIALS AND METHODS:A 9-month parallel-group randomized controlled trial was carried out on 40 children with Class II malocclusion, aged 8-12 years, half assigned to receive a cervical headgear and half to a no-treatment group, using block randomization. Subjects in the treatment group were instructed to wear the headgear for 12 hours daily and monitored using an electronic module. After 9 months, the following dental outcomes were measured: first maxillary molar distalisation, rotation, tip and torque, arch depth, and interpremolar and intermolar distances. Caregivers and participants were not blinded to group assignments, but those assessing outcomes were. Linear regression models were used to detect differences between groups and correlation coefficients to find correlations between compliance and dental outcomes. RESULTS:All 40 included patients were analysed. A significant difference in molar distalisation was observed between the treatment (1.2 mm) and control groups (-0.2 mm). Arch depth change was also increased to a larger extent in the treatment groups (1.3 mm vs 0.1 mm), as was the interpremolar distance (1.9 mm vs 0.4 mm). In contrast, no significant differences in molar rotation or torque change were observed. With regard to compliance, average compliance was 55%. A significant correlation was found between molar distalisation and compliance in the treatment group. CONCLUSIONS:Headgear therapy has significant effects on molar distalisation, arch depth, and arch width. Compliance has a significant positive effect on molar distalisation.