NCT07290790 A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.
| NCT ID | NCT07290790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dentsply Sirona Implants and Consumables |
| Condition | Malocclusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 spacing must be ≤6mm present in one or both arches consistent with level 1 and 2 of case complexity. * Midline deviation must be ≤3 mm consistent with level 1 and 2 of case complexity. * Overjet must be ≤4 mm consistent with level 1 and 2 case complexity. * Overbite must be ≤3 mm consistent with level 1 and 2 case complexity. * Anterior open bite must be ≤1 mm, consistent with level 1 and 2 case complexi