NCT07091422 A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
| NCT ID | NCT07091422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Bracket Bonding |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-08-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-11-05 with a primary completion date of 2026-08-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07091422 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 35 Years, studying Bracket Bonding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07091422 currently recruiting?
Yes, NCT07091422 is actively recruiting participants. Contact the research team at fcopello@umaryland.edu for enrollment information.
Where is the NCT07091422 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07091422 clinical trial?
NCT07091422 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 20 participants.