A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
University of Maryland, Baltimore
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.
Description
This is a prospective, randomized, split-mouth clinical trial designed to compare the bond failure rate, bonding efficiency, and enamel outcomes of a novel etch-free orthodontic adhesive with a conventional acid-etch adhesive over a 12-month follow-up period. Background and Rationale Conventional orthodontic bonding requires phosphoric acid etching to create surface roughness for adhesive retention. While effective, this process irreversibly demineralizes enamel and may increase susceptibility to white spot lesions (WSLs), decalcification, and enamel fractures during bracket removal. A new g…
Eligibility
- Age range
- 14–35 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DeviceEtch-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.
- DeviceConventional 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.
Location
- University of Maryland Baltimore School of DentistryBaltimore, Maryland