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

University of Maryland, Baltimore · NCT07091422

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 14–35 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
November 5, 2025
Record last updated
November 10, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Etch-Free Adhesive; Conventional Etch-and-Bond Adhesive

Conditions: Bracket Bonding; Orthodontic Treatment; Dental Adhesives/Restorations Performance; White Spot Lesion of Tooth

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Maryland Baltimore School of Dentistry

    Baltimore, MD 21201

    Site contact: Vineet Vineet, DDS, PhD · 410 706 7970 · vdhar@umaryland.edu

Study contacts (from the official record)

  • Flavio Copello, DDS, MS, PhD · 4108043239 · fcopello@umaryland.edu
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A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a… (NCT07091422) | Bored Studies