Status:
COMPLETED
Orthodontic Varnish Microbiology Study
Lead Sponsor:
University of California, Los Angeles
Conditions:
Dental Caries
Dental Plaque
Eligibility:
All Genders
12-27 years
Phase:
NA
Brief Summary
Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and...
Detailed Description
1. Orthodontic patients ages 12-27 (target 120 subjects) nearing the end of treatment with metal braces at the UCLA Orthodontic Clinic will be recruited. 2. Patients will be consented by the investiga...
Eligibility Criteria
Inclusion
- Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed
- Systemically healthy, as determined by the investigator (in consultation with the Medical Monitor, as needed), based on medical history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during screening
- Is approaching the end of their orthodontic treatment using metal fixed oral appliances (brackets) on at least the maxillary arch
- Subject has at least two visible white spot lesions at the time of recruitment on teeth treated with fixed oral appliances
- Subject is willing to use only oral care products that fall within the standard of care (manual toothbrush and sodium fluoride toothpaste) for the duration of the study.
- Subject is willing to postpone dental cleanings between the baseline and final visit (since subjects will receive cleanings 6 months apart at both the baseline and final visit, the standard of care will be maintained).
- Subject is willing and able to comply with oral hygiene and diet instructions.
- Subject is able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures
- Subject is able to communicate with the Investigator/study personnel, understand and comply with the study requirements, and is willing to return for protocol-specified visits at the appointed times.
Exclusion
- Advanced periodontal disease
- Medical condition (e.g. artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity (suspected or confirmed)
- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the investigators could influence the study outcome, within 30 days prior to screening.
- Presence of any condition or concurrent illness, which in the opinion of the investigators, would compromise normal immune function ((e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results
- Presence of xerostomia (dry mouth).
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04528134
Start Date
February 7 2022
End Date
July 1 2025
Last Update
August 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA School of Dentistry
Los Angeles, California, United States, 90095