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

NCT07091422 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-10

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2026-08-11
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091422 on ClinicalTrials.gov