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

RecruitingNAAges 14 Years - 35 YearsAllUniversity of Maryland, Baltimore
NCT07091422 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, ea

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📋 Eligibility rules (as published)
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
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What it tests

  • Etch-Free Adhesive
  • Conventional Etch-and-Bond Adhesive
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Where

1 site
University of Maryland Baltimore School of Dentistry
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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