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

NCT07290790 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Dentsply Sirona Implants and Consumables

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2027-12-31
Completion
2028-02-01
FDA Device
Yes

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290790 on ClinicalTrials.gov