West Windsor Township

Researchers are evaluating the SureSmile clear aligner medical device in a three-armed, multicenter clinical study focused on patients with dental malocclusion. The primary goal is to confirm the safety and assess the accuracy of different tooth movements during treatment. The study also compares three different aligner trimline designs: Scalloped, Straight, and Straight Extended. Participants will be treated using SureSmile Clear Aligners, which are custom-made devices designed to fit different mouth shapes and sizes. The study groups differ only by the trimline design used on the aligners. All other pre-treatment, treatment, and post-treatment procedures and materials are the same across groups. Treatment duration typically ranges from 6 to 18 months, depending on the individual treatment plan. During the study, participants will undergo assessments of tooth movement accuracy at the beginning and end of the treatment period. Researchers will monitor the progress through clinical visits and follow-ups, evaluating how well the aligners achieve the planned tooth positions. Safety and adherence to treatment protocols will also be observed throughout the study period.