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RECRUITING
NCT07091422
NA

A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

This randomized, split-mouth clinical trial will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and enamel damage. The etch-free adhesive under investigation is designed to simplify the bonding procedure while preserving enamel integrity. Twenty orthodontic patients starting treatment with braces will participate. For each patient, one side of the mouth (left or right) will be randomly assigned to receive the etch-free adhesive, while the opposite side will receive the conventional adhesive with acid etching. This intra-patient design allows a direct comparison under identical oral conditions. Participants will be followed for 12 months. Bracket failures, bonding time, ease of adhesive removal, enamel surface condition after debonding, and the presence of white spot lesions will be recorded. If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for orthodontic patients.

Key Details

Gender

All

Age Range

14 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-11-05

Completion Date

2026-12-01

Last Updated

2025-11-10

Healthy Volunteers

Yes

Interventions

DEVICE

Etch-Free Adhesive

A self-adhesive orthodontic bonding material applied directly to enamel without prior phosphoric acid etching or primer application. Brackets are bonded following the manufacturer's instructions.

DEVICE

Conventional Etch-and-Bond Adhesive

A standard orthodontic bonding protocol using 35-37% phosphoric acid etching, primer application, and a conventional light-cure adhesive. Brackets are bonded following the manufacturer's recommended procedure.

Locations (1)

University of Maryland Baltimore School of Dentistry

Baltimore, Maryland, United States