Recruiting

Etch-Free Adhesive

Sponsor:

University of Maryland, Baltimore

Code:

NCT07091422

Conditions

Bracket Bonding

Orthodontic Treatment

Dental Adhesives/Restorations Performance

White Spot Lesion of Tooth

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Accepted

Interventions

Etch-Free Adhesive

Conventional Etch-and-Bond Adhesive

Study Details

Brief 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.

Conditions

Bracket Bonding

Orthodontic Treatment

Dental Adhesives/Restorations Performance

White Spot Lesion of Tooth

Study ID

NCT07091422

Start date

Nov 5, 2025

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Bracket Failure Rate [ Time Frame: Through study completion, up to 12 months post-bonding (evaluated at each routine orthodontic visit). ]

Central Contacts and Locations

Central contacts

Flavio Copello, DDS, MS, PhD

4108043239fcopello@umaryland.edu

Locations

University of Maryland Baltimore School of Dentistry

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Vineet Vineet, DDS, PhD

410 706 7970vdhar@umaryland.edu

Principal Investigator:

Flavio Copello, DDS, MSc, PhD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Etch-Free Adhesive
  • Orthodontic Bonding
  • Bracket Failure
  • Split-Mouth Trial
  • White Spot Lesions
  • Orthodontics Clinical Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-11-10.