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NOT YET RECRUITING
NCT07881146
NA

A Novel Attachment Design for Tooth Rotation With Clear Aligner Therapy

Sponsor: Boston University

View on ClinicalTrials.gov

Summary

Clear aligners are thin, transparent plastic trays that straighten teeth gradually and are a popular, more discreet alternative to traditional braces. To help the traOptionalys grip and move the teeth, dentists usually bond small tooth-colored bumps, called "attachments," onto the front or back surfaces of the teeth. Although aligners work well for many types of tooth movement, they are much less reliable at turning (rotating) teeth that are twisted out of position, especially rounded teeth such as premolars and canines. Teeth often turn less than planned or tip and shift in unwanted directions. As a result, patients may need extra sets of aligners or a period of conventional braces, which takes away the main reason many people choose aligners. This study will evaluate the clinical performance of the proposed occlusal attachment designed by the investigators, quantifying rotational correction along with any unintended movements of the target and adjacent teeth. The study is not designed as a device trial of the aligner system, but as an evaluation of a modified attachment configuration within routine clear aligner treatment. The Primary Objective is to determine the degree of rotational correction that can be achieved in rotated canines and/or premolars using clear aligners with occlusal surface attachments. The Secondary Objective is to assess any unintended tooth movements, including buccolingual tipping, mesiodistal translation and vertical displacement.

Key Details

Gender

All

Age Range

22 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-12

Completion Date

2027-12

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DEVICE

novel attachment configuration

Standard clear aligner therapy using a commercially available system (e.g., Invisalign or equivalent) in which at least one rotated canine or premolar per subject will receive a conventional attachment placed on the occlusal surface and be designated as the index tooth for outcome assessment. No experimental materials will be used; only the attachment position differs from standard practice, and the aligners themselves are FDA- cleared devices manufactured according to existing protocols.

Locations (1)

Boston University Henry M Goldman School of Dental Medicine, Orthodontic Clinic

Boston, Massachusetts, United States