Orthodontic Varnish Microbiology Study

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Aug 22, 2020

Keywords

ClinConnect Summary

The Orthodontic Varnish Microbiology Study is looking at how well different fluoride varnishes can help treat white spot lesions, which are the early signs of cavities that often appear after orthodontic treatment, like braces. The study will involve teenagers aged 12 to 17 who have at least two visible white spots on their teeth and are nearing the end of their orthodontic treatment. Participants will be randomly assigned to receive one of three treatments on different sides of their mouths: a placebo (no active treatment), a traditional fluoride varnish, or a special resin-based fluoride varnish.

During the study, which will last about six months, participants will have four visits to the dental office. At each visit, their oral health will be checked, and pictures of their teeth will be taken. They will also be asked to maintain good oral hygiene by brushing with fluoride toothpaste and flossing daily. This study aims to find out which treatment is most effective at improving the health of their teeth and the balance of bacteria in their mouths. Participants will need to be in good health and willing to follow specific care instructions throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).