A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jul 21, 2025
Trial Information
Current as of August 20, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to attach braces to teeth that might be gentler on the teeth’s surface. Normally, orthodontists use a mild acid to prepare the tooth before sticking on the braces, but this acid can sometimes weaken the outer layer of the tooth and cause white spots or damage. The new method uses a special glue that doesn’t require this acid step, which could make the process easier and better for your teeth.
The study will involve about 20 people, aged 14 to 35, who need braces on both the upper and lower teeth. For each person, one side of the mouth will get the new glue without acid, and the other side will get the usual method with acid. This way, the researchers can directly compare how well each method works in the same mouth. Participants will be followed for a year to see how often brackets come loose, how easy the glue is to remove, and how the teeth look after the braces are taken off. If the new glue works well, it could offer a safer and simpler option for future orthodontic treatments.
Gender
ALL
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
About University Of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMB leverages its extensive resources and expertise across various disciplines, including medicine, pharmacy, nursing, and social work, to contribute to groundbreaking discoveries and improve patient outcomes. Committed to ethical research practices and collaboration, UMB fosters an environment that promotes the translation of scientific knowledge into real-world applications, ultimately enhancing the well-being of diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported