Comparisons of costs and treatment effects—an RCT on headgear activator treatment of excessive overjet in the mixed and late mixed dentition

Abstract

Abstract Objectives To compare the costs and treatment effects of headgear activator treatment of Class II malocclusion with excessive overjet between treatments started in the mixed (MD) and late mixed dentition (LMD). Trial design Two-arm parallel-group single-centre randomized controlled trial (RCT). Material and methods A total of 56 children presenting Class II malocclusion with excessive overjet were assessed and invited to an RCT designed as intention-to-treat. The children were randomized, by an independent person not involved in the trial into two groups, treatment with headgear activator in the MD starting at the age of 9 or to treatment with a headgear activator in LMD, starting at the age of 11. The primary outcome measure was to compare the treatment costs between the two groups. Societal costs (the sum of direct and indirect costs) were calculated for successful treatments only and when unsuccessful treatments were included. Secondary outcomes were comparisons of oral health-related quality of life (OHRQoL), dental and skeletal treatment effects, lip closure, and trauma incidence. Data collections were performed before and after treatment, corresponding to a treatment period of 2 years. Blinding was accomplished when assessing outcomes. Results No group differences in costs were found of successful treatments or when unsuccessful treatments were included. The most pronounced treatment effects in both groups were the reduction of overjet and improved molar relation. Treatment started in MD or in LMD were equal and without significant differences regarding effects on OHRQoL, skeletal effects, lip closure, and incidence of trauma. Harms No harm was observed, but 8 of 30 children (27%) in the MD and 6 of 21 children (29%) in the LMD group showed unsuccessful results. Limitations Costs depend on local factors and can thereby not be directly transferred to other settings. It was a single-centre trial and can thus be less generalizable. Conclusions Regarding costs and treatment effects, there is no difference if headgear activator treatment of excessive overjet starts in the MD or LMD. Clinical trial registration NCT04508322.