Study Evaluating Accuracy of SureSmile Clear Aligners With Three Different Trimline Designs in Adults Undergoing Clear Aligner Therapy

What this Trial Is About

Researchers are evaluating the SureSmile clear aligner medical device in a three-armed, multicenter clinical study focused on patients with malocclusion. The primary goal is to confirm the safety and measure the accuracy of different tooth movements using three distinct trimline designs Scalloped, Straight, and Straight Extended. This study aims to compare these designs to better understand their performance during clear aligner therapy. Participants will receive one of three SureSmile clear aligner designs, each customized to fit different mouth shapes and sizes. The study groups include the scalloped trimline design, the straight trimline design, and the straight extended trimline design with a 2 mm extension. All other treatment protocols and materials are consistent across groups. The treatment period typically lasts between 6 to 18 months, followed by a refinement period averaging 8 to 12 weeks. During the study, participants will be monitored regularly for tooth movement accuracy, comfort and pain levels every 8 weeks, and any adverse events or device issues from the start of treatment until the retainer delivery visit, which occurs about 18 months after treatment begins. Researchers will assess outcomes based on the planned treatment and gather data on refinement rates and safety. Participant involvement includes follow-up visits for assessments throughout the treatment and refinement periods.

A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.