Oral health-related quality of life, adaptation/discomfort during open bite treatment with spurs: complementary analysis from a randomized clinical trial.

This single-center trial aimed to longitudinally compare the oral health-related quality of life (OHRQOL), adaptation and discomfort during anterior open bite (AOB) treatment with lingual spurs and build-ups (SBU) versus spurs only (S) approaches. Children (7-11 years) with AOB were randomly allocated into two treatment groups (SBU or S). The Child Perception Questionnaire (CPQ8-10 ) was applied 1 and 12 months after installation of the appliances. Questionnaires evaluating functional adaptation and discomfort during the first month of treatment were also applied. A visual analog scale (VAS) was used in these questionnaires. Generalized mixed models were used for analyzing OHRQOL and discomfort data. Generalized linear models were used to assess adaptation outcomes (α = 0.05). The SBU group included 24 patients (7 males and 17 females; mean age 8.2 years) and the S group included 25 patients (11 males and 14 females; mean age 8.3 years). Regardless of the treatment type, overall OHRQOL scores at 12 months were 0.69 times those recorded at 1 month after the appliances installation (i.e., ~ 31% reduction; exp (β) = 0.69; 95% CI: 0.55, 0.88). A significant interaction between treatment and time was detected for the 'functional limitations' domain. For this domain, a significant improvement from the first to the twelfth month was observed in the S group (P < 0.001). Patients in both treatment groups showed similar and easy adaptation to the appliances. Independent of the type of treatment, tongue-related discomfort decreased over time. One week and one month after the appliance's delivery, the discomfort scores were 0.19 (i.e., ~ 81% reduction; exp (β) = 0.19; 95% CI: 0.13, 0.28; P < 0.001) and 0.02 (i.e., ~ 98% reduction; exp (β) = 0.02; 95% CI: 0.01, 0.07; P < 0.001) times, respectively, those issued immediately after the installation of the appliances. Regardless of treatment type; overall OHRQOL improved from the first to the twelfth month of AOB treatment. The functional limitations score decreased in the S group. Children showed easy adaptation, and their discomfort decreased 1 week after the installation of the appliances.Trial registration: Clinicaltrials.gov; NCT03702881, date of registration: October 11, 2018.