RecruitingNot ApplicableNCT07091422

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


Sponsor

University of Maryland, Baltimore

Enrollment

20 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Conventional Etch-and-Bond Adhesive and a medical device called Etch-Free Adhesive for people with bracket bonding, dental adhesives/restorations performance, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEtch-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.

DEVICEConventional 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

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NCT07091422


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