A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
University of Maryland, Baltimore
20 participants
Nov 5, 2025
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
Plain Language Summary
Simplified for easier understanding
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
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.
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)
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NCT07091422