Comparing a new etch-free adhesive with standard etch-and-bond for braces bracket retention

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

This test will see if a new etch-free adhesive for braces holds brackets as well as the standard acid-etch method in patients starting fixed orthodontic treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 35 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07091422 on ClinicalTrials.gov

What this trial studies

This is a randomized, split-mouth trial in which 20 patients receiving fixed orthodontic treatment will have one side of the mouth bonded with an etch-free adhesive and the opposite side bonded with a conventional acid-etch adhesive. Outcomes measured over 12 months include bracket failure rate, bonding time, ease of adhesive removal, enamel surface condition after debonding, and development of white spot lesions. The within-patient design controls for individual differences in oral hygiene, diet, and occlusion. The trial is conducted at a university-based orthodontic clinic.

Who should consider this trial

Good fit: Ideal candidates are patients aged about 14–35 years starting comprehensive fixed orthodontic treatment with permanent teeth, good general health, and at least 10 bondable teeth per arch who can attend follow-up for 12 months.

Not a fit: Patients with significant enamel defects or restorations at bonding sites, active decay or periodontal disease, prior orthodontic treatment, known adhesive allergies, or systemic conditions affecting oral health are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the etch-free adhesive could preserve enamel, reduce the risk of white spot lesions, and shorten bonding time during orthodontic care.

How similar studies have performed: Short-term studies of self-adhesive or etch-free orthodontic materials have shown promising bond strengths, but long-term effects on enamel and white spot lesion prevention are less well-established.

Eligibility criteria

Inclusion Criteria:

Patients aged 14 to 35 years

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:

Presence of systemic diseases or conditions that affect oral health or healing (e.g., uncontrolled diabetes, immunosuppression)

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

Where this trial is running

Baltimore, Maryland

• University of Maryland Baltimore School of Dentistry — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: Flavio Copello, DDS, MS, PhD

Conditions: Bracket Bonding, Orthodontic Treatment, Dental Adhesives/Restorations Performance, White Spot Lesion of Tooth, Etch-Free Adhesive, Orthodontic Bonding, Bracket Failure, Split-Mouth Trial