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

Recruiting now · Not applicable

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

In brief

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 facts

Study ID

NCT07091422

Run by

University of Maryland, Baltimore

People needed

20

Starts

2025-11-05

Expected to finish

2026-12-01

Last updated by the study team

2025-11-10

Who can join

Age: 14 and older, up to 35. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Maryland Baltimore School of Dentistry — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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