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

Who can join

Ages 14 to 35 · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Etch-Free Adhesive (device)
• Conventional Etch-and-Bond Adhesive (device)

Sponsor: University of Maryland, Baltimore · Participants: 20 · Started: Nov 5, 2025

Contact the study team

• Flavio Copello, DDS, MS, PhD · Phone: 4108043239

Official record on ClinicalTrials.gov — NCT07091422

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.