A Prospective, Multicenter, Randomized, Post-market Clinical Investigation to Assess the Accuracy of Different Tooth Movements for Patients Undergoing Clear Aligner Therapy (CAT) With SureSmile® Clear Aligners With Three Different Trimlines.
Dentsply Sirona Implants and Consumables
Summary
This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements. In addition, the study will investigate and compare three different trimline designs: Scalloped, Straight, and Straight Extended.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well as associated time commitment and follow-ups visits. * Subject has signed and dated the informed consent form (ICF) . * Subject aged 18 years or above at time of informed consent. * Subject has permanent dentition (i.e., all 2nd molars). * Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile Case Selection Guide. * Crowding or spa…