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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07091422
Status
Recruiting
Apply to this trial

Conditions

  • Bracket Bonding
  • Dental Adhesives/Restorations Performance
  • Orthodontic Treatment
  • White Spot Lesion of Tooth

Eligibility Criteria

Sex
ALL
Age
14 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Etch-Free Adhesive — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 5, 2025
Status verified
Nov 2025
Primary completion
Aug 11, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore School of DentistryBaltimoreMaryland21201
Vineet Vineet, DDS, PhD
[email protected]
410 706 7970
Flavio Copello, DDS, MSc, PhD (PRINCIPAL_INVESTIGATOR)
Sydney Gladfelter, DDS (SUB_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
University of Maryland Baltimore School of Dentistry· Baltimore, MD

Related Studies