NCT07290790

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	SureSmile® Clear Aligners	SureSmile® Clear Aligners are Custom-made (EU)/patient matched (US) medical devices made to fit appliance with different diameters and lengths to accommodate subjects with different mouth shapes and sizes. This clinical investigation consists of three different trimline designs groups: * SureSmile aligner Scallop trimline design * SureSmile aligner Straight trimline design * SureSmile aligner Straight extended trimline design All pre-treatment, treatment, and post-treatment protocols and materials used in all groups are identical, except for the type of trimline design.

Timeline

• Start date: 2026-01-29
• Primary completion: 2027-12-31
• Completion: 2028-02-01
• First posted: 2025-12-18
• Last updated: 2026-03-09

Locations

6 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated device study