Wear-time monitoring in functional orthodontic appliances does not enhance patient satisfaction and is not associated with improved treatment duration or occlusal outcomes: A randomized controlled trial.

BACKGROUND: Thermosensitive microsensors help assess removable appliance wear-time compliance and thereby provide objective feedback to the patient. METHODS: This single-center, two-parallel-arm randomized controlled trial assessed the impact of wear-time monitoring in removable functional appliances on patients' subjective experience, treatment duration, and outcome. In total, 58 patients aged between 10 and 15 years were treated with either a twin-block appliance or headgear activator. The patients were randomly allocated to two groups, one of which received wear-time monitoring while the other did not. Data were analyzed on an intention-to-treat and per-protocol basis using parametric and nonparametric statistics to assess associations between the outcome variables. No blinding of the patient or orthodontist was carried out. No harms were detected. RESULTS: Adolescents reported wear comfort ranging from poor to excellent, significantly correlating with wear time and malocclusion correction success, but not with treatment duration. The twin-block appliance was worn for an average of 10 hours a day, while the headgear activator was worn for 4 hours a day. For those 39 adolescents with successful occlusal outcomes, mean wear time was 10 hours and 9 hours, respectively, and the average treatment duration was 13 months. The dropout rate was 21%. CONCLUSIONS: Wear-time monitoring in twin-block appliance and headgear activator did not significantly increase subjective satisfaction, shorten the treatment time, or increase the frequency of successful occlusal outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05213338.