Individualizing Aligner Change Schedule: A Single-Blind, Randomized Controlled Trial

Abstract

Introduction: Presently, patients’ aligner change frequency and wear time are primarily determined by the clinician’s judgment rather than by literature comparing distinct protocols. The aims of this study are to evaluate DentalMonitoring (DM; Paris, France)’s ability to personalize patients’ treatment schedules and to determine the effect of full-time versus half-time wear as well as usage versus non-usage of VPro+ (Propel Orthodontics; Ossining, NY) on treatment duration. Methods: Clear aligner patients at the Harvard School of Dental Medicine Orthodontics Clinics were randomized into 4 groups: Group 1 (full-time wear, no VPro+), Group 2 (full-time wear, VPro+), Group 3 (half-time wear, no VPro+), and Group 4 (half-time wear, VPro+). All groups submitted intraoral scans to DM every 4 days and followed DM’s aligner change instructions for 10 trays. Treatment durations for each group were compared with standard protocols of 7-14 days/tray and between groups by a statistician blinded to the group descriptions. Results: Of the 76 patients enrolled, 48 patients (12 per group) completed the study. All groups progressed through aligners more efficiently (4.315-5.370 days/tray) than standard protocols of 7-14 days/tray (p.01). Full-time groups (4.407 days/tray) progressed through aligners more efficiently (p=0.0007) than half-time groups (5.310 days/tray). No effect (p=0.6931) was observed between VPro+ (4.782 days/tray) and no VPro+ groups (4.935 days/tray). Conclusions: Clear aligner protocols should be individualized for each patient and each set of aligners. Patients scanning every 4 days with DM progressed through aligners more quickly than a standardized change frequency of 7-14 days/tray. Treatment efficiency was improved with increased daily wear time but not affected by VPro+ usage. DentalMonitoring can serve as a valuable treatment adjunct and future research tool by improving the efficiency and individualization of clear aligner therapy. Registration: This randomized clinical trial was registered and reported at ClinicalTrials.gov (NCT04260633). Protocol: The protocol was not published before trial commencement. Funding: This study was funded by an AAO Foundation Biomedical Research Award.