Oral health-related quality of life of children before, during, and after anterior open bite correction: A single-blinded randomized controlled trial.

Abstract

One of the goals of malocclusion treatment is to improve the oral health-related quality of life (OHRQoL) of patients. The aim of this trial was to assess the OHRQoL of children before, during, and after anterior open bite (AOB) correction, compared with nontreated children, in a 2-arm parallel single-blind randomized controlled trial. Eighty children with AOB aged 8-10years were randomly assigned to 2 groups (n=40 each): a group treated with the use of fixed palatal crib (FPC; TG) and a control group (nontreated; CG). Randomization was performed with the use of BioEstat software. The outcome (OHRQoL) was assessed with the use of the validated Brazilian Portuguese version of the Child Perceptions Questionnaire (CPQ8-10) applied before (baseline, phase 1), 3months after FPC placement (phase 2), and 1month after FPC removal (phase 3) in the TG. In the CG, CPQ8-10 was applied at baseline (phase 1), 3months (phase 2), and 12months (phase 3). Data were analyzed by means of a blinded statistic with the use of Friedman, Wilcoxon, and Mann-Whitney tests (α=0.05). All participants finished the RCT, and demographic characteristics were similar between groups. In phase 1, the TG had lower scores for the "social well-being" domain (P=0.02). In phase 2, the CG had higher scores than the TG for the "emotional well-being" and "social well-being" domains, but the opposite was observed for "oral symptoms" and "functional limitations" (P<0.001). In phase 3, the TG showed a lower impact on OHRQoL than the CG in all domains and in the overall score (P<0.001). In the 3 phases, the CG showed progressive increase (mean scores 70.37, 74.70, and 84.22, respectively; P<0.001) and the TG a decrease (mean scores 70.20, 70.80, and 6.05, respectively; P<0.001) in overall scores. The increase of scores in the CG was considered to represent a serious harm. Correction of AOB had a positive impact and failure to correct it had a negative impact on the OHRQoL of children. This trial was not registered. The protocol was not published before trial commencement.