Actively Recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Led by University of Maryland, Baltimore · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new orthodontic adhesive that does not require acid etching before bonding brackets. This study involves 20 patients aged 14 to 35 years undergoing fixed orthodontic treatment. The goal is to compare the new etch-free adhesive with the conventional acid-etch adhesive to see if it can reduce enamel damage and white spot lesions while maintaining bond strength. The trial uses a split-mouth design where one side of each patient's mouth receives the etch-free adhesive and the other side the conventional adhesive with phosphoric acid etching. Bonding times will be measured, and brackets will be placed following manufacturer instructions. Patients will be followed for 12 months to assess bracket failures, enamel condition, adhesive remnants, and white spot lesion formation. Participants will attend monthly visits during the 12-month follow-up to record bracket failures and enamel condition through clinical and photographic assessments. Bonding time, adhesive removal ease, and patient discomfort will also be recorded. Data will be securely stored and analyzed to evaluate the performance and safety of the new adhesive compared to the standard method.
CONDITIONS
Brief Title
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 14 to 35 years
- Require comprehensive fixed orthodontic treatment with brackets on both arches
- Good general health with no contraindications to orthodontic treatment
- Have at least 10 permanent teeth per arch suitable for bracket bonding
- Able and willing to comply with study visits and follow-up for at least 12 months
- Parent or guardian consent and child assent obtained as appropriate
You will not qualify if you...
- Have systemic diseases or conditions affecting oral health or healing (e.g., uncontrolled diabetes, immunosuppression)
- Have teeth with significant enamel defects, restorations, or caries in bonding areas
- Currently undergoing or previously had orthodontic treatment
- History of allergy or sensitivity to dental adhesives or related materials
- Poor oral hygiene or active periodontal disease
- Use medications affecting tooth enamel or oral tissues (e.g., long-term corticosteroids)
- Unable to attend follow-up visits or comply with study requirements
- Participate in another clinical trial that could interfere with study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 1 day
Participants receive orthodontic bracket bonding on both sides of the mouth using two different adhesive methods: a new etch-free adhesive on one side and a conventional acid-etch adhesive on the other side. Bonding time per side is measured during the initial appointment.
1 baseline visit (in-person) for bonding procedure
Duration - 12 months
Participants attend regular monthly visits to check bracket status and oral health. White spot lesions are assessed at baseline, 6 months, and 12 months. Enamel condition and adhesive remnant index are evaluated at debonding approximately 12 months after bonding.
Monthly visits up to 12 months with additional assessments at baseline, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
University of Maryland Baltimore School of Dentistry
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
F
Flavio Copello, DDS, MS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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