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

NCT07091422 | Recruiting FDA Device

• 1 other identifier: HP-00115604
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bracket Failure Rate

  The proportion of brackets bonded with each adhesive (etch-free vs. conventional) that experience bond failure over a 12-month follow-up period. A bond failure is defined as a clinically detached bracket requiring rebonding.

  Through study completion, up to 12 months post-bonding (evaluated at each routine orthodontic visit).

Secondary Outcomes (4)

• Bonding Time Per Quadrant

  At the initial bonding appointment (Day 1).

• Adhesive Remnant Index (ARI) at Debonding

  At debonding (approximately 12 months post-bonding or at completion of treatment).

• Enamel Surface Integrity

  At debonding (approximately 12 months post-bonding).

• White Spot Lesion (WSL) Formation

  At baseline (Day 1), 6 months, and 12 months post-bonding.

Study Arms (2)

Etch-Free Adhesive

EXPERIMENTAL

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.

Device: Etch-Free Adhesive

Conventional Etch-and-Bond Adhesive

EXPERIMENTAL

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.

Device: Conventional Etch-and-Bond Adhesive

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.

Etch-Free Adhesive

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.

Conventional Etch-and-Bond Adhesive

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore School of Dentistry

Baltimore, Maryland, 21201, United States

RECRUITING

Central Study Contacts

Flavio Copello, DDS, MS, PhD

CONTACT

4108043239; fcopello@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded (Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Flavio Copello, DDS, Principal Investigator, Clinical Assistant Professor

Model Details: Split-mouth

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 29, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)