Objective assessment of wear time during orthodontic aligner therapy using microsensors: A randomized controlled trial

INTRODUCTION: The clinical effectiveness of aligners is impacted by wear time (WT). This study aimed to objectively assess WT using microsensors and to evaluate whether patient awareness of monitoring affects WT. METHODS: This study was designed as a single-center, 2-arm, parallel-group randomized controlled trial in 43 adult patients. Orthodontic aligner treatment with an integrated microsensor was used to assess WT across 6 consecutive appointments, scheduled biweekly. Patients were randomly assigned to group 1 or 2 in a 1:1 ratio using an online randomization tool. Allocation was concealed using sequentially numbered opaque, sealed envelopes. Patients were either informed about the use of microsensors to register intraoral temperature (group 1, "unaware") or to assess patient compliance based on the temperature data (group 2, "aware"). Operators and patients could not be blinded to the treatment allocation. However, outcome assessment was blinded. A linear mixed model was used to estimate the effect of study arm on WT per wave, with age and sex included as explanatory variables. RESULTS: At follow-up, 3 patients discontinued intervention. Forty patients were included in the final analysis (male, 12; female, 28; mean age, 36.2 ± 14.2 years). The linear mixed model showed that awareness of monitoring (group 2) resulted in significantly higher WT, with an increase of 4.41 h/d (95% confidence interval, 1.88-6.93, P = 0.0011). WT declined significantly at later visits. No harms or adverse effects were reported or observed. CONCLUSIONS: Awareness of being monitored improved patient compliance and can be used as an effective strategy to enhance WT during aligner therapy in adults. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00029027).