A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
NCT ID: NCT07091422
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-11-05
2026-12-01
Brief Summary
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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.
Detailed Description
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Background and Rationale Conventional orthodontic bonding requires phosphoric acid etching to create surface roughness for adhesive retention. While effective, this process irreversibly demineralizes enamel and may increase susceptibility to white spot lesions (WSLs), decalcification, and enamel fractures during bracket removal.
A new generation of self-adhesive bonding materials eliminates the etching step by bonding directly to enamel. This simplified approach may preserve enamel integrity, reduce chair time, and improve the patient experience while maintaining adequate bond strength.
The split-mouth design allows direct intra-patient comparison of the two bonding methods under identical oral conditions (hygiene, diet, occlusal forces), reducing inter-patient variability.
Study Design Type: Prospective, randomized, split-mouth trial
Population: 20 patients (ages ≥12 years) with permanent dentition undergoing fixed orthodontic treatment
Follow-up duration: 12 months post-bonding
Setting: University-based orthodontic clinic
Interventions Test Adhesive (Experimental): A commercially available etch-free adhesive system applied directly to enamel without acid etching or separate priming.
Control Adhesive: Conventional orthodontic adhesive applied following 37% phosphoric acid etching, primer, and adhesive placement.
Randomization and Bonding Procedure Each patient will receive both adhesives-one on the left side and one on the right-randomly assigned using a computer-generated randomization schedule and sealed envelopes.
Bonding will be performed by a calibrated operator using identical brackets and bonding techniques.
Control side: 37% phosphoric acid etch (30 seconds), rinse, dry, primer, and adhesive.
Experimental side: Etch-free adhesive applied directly per manufacturer instructions.
Bonding time for each side will be measured with a stopwatch.
Sample Size Justification Twenty patients will contribute approximately 212 bonded brackets (10-12 per side, excluding molars and second premolars). This sample size provides 80% power to detect a clinically meaningful difference in bond failure rates (expected 5% failure rate for the etch-free adhesive vs. 10% for conventional adhesive; α = 0.05), analyzed using McNemar's test for paired binary outcomes.
Outcome Measures Primary Outcome
Bracket Failure Rate: Number and location of dislodged brackets on test vs. control sides recorded at monthly visits.
Secondary Outcomes
Bonding Time: Measured in seconds per side.
Enamel Condition at Debonding: Assessed clinically and photographically by blinded evaluators.
Adhesive Remnant Index (ARI): Scored 0-3 after debonding.
White Spot Lesions (WSLs): Presence and severity assessed clinically and photographically at baseline and after 12 months using standardized scoring.
Patient-Reported Outcomes (if applicable): Discomfort related to bonding/debonding.
Data Collection and Management Data will be recorded using standardized forms and stored on secure, encrypted institutional servers.
Clinical photographs will document enamel condition and WSLs.
All data will be coded and de-identified. Only authorized study personnel will have access.
Ethical Considerations The study has been reviewed by the University of Maryland Institutional Review Board (IRB #HP-00115604) and determined to be minimal risk.
Written informed consent will be obtained from adult participants; minors will provide assent with parental consent.
Both adhesives are commercially available and widely used in clinical practice; no experimental drugs or devices are involved.
No additional radiographs or invasive procedures are required beyond standard care.
Participants may withdraw at any time without affecting their ongoing treatment.
This trial seeks to determine whether an etch-free adhesive can reduce enamel damage and improve bonding efficiency without compromising clinical performance.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Etch-Free Adhesive
Teeth on one randomized side of the mouth will be bonded with a novel self-adhesive orthodontic material that does not require prior acid etching or primer application.
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.
Conventional Etch-and-Bond Adhesive
Teeth on the contralateral side of the mouth will be bonded using the standard orthodontic bonding protocol with 35-37% phosphoric acid etching, primer, and conventional resin adhesive.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Requiring comprehensive fixed orthodontic treatment with brackets on both arches
Good general health with no contraindications to orthodontic treatment
Presence of at least 10 permanent teeth per arch suitable for bracket bonding
Ability and willingness to comply with study visits and follow-up for at least 12 months
Parent/guardian consent and child assent obtained as appropriate
Exclusion Criteria
Teeth with significant enamel defects, restorations, or caries in bonding areas
Patients currently undergoing or who have undergone orthodontic treatment previously
History of allergy or sensitivity to dental adhesives or related materials
Patients with poor oral hygiene or active periodontal disease
Use of medications known to affect tooth enamel or oral tissues (e.g., long-term corticosteroids)
Inability to attend follow-up visits or anticipated lack of compliance
Participation in another clinical trial that could interfere with study outcomes
14 Years
35 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Flavio Copello
Dr Flavio Copello, DDS, Principal Investigator, Clinical Assistant Professor
Locations
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University of Maryland Baltimore School of Dentistry
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Vineet Vineet, DDS, PhD
Role: primary
Other Identifiers
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HP-00115604
Identifier Type: -
Identifier Source: org_study_id