Orthodontic Varnish Microbiology Study

Completed · Not applicable · Has a placebo group

Conditions studied: Dental Caries, Dental Plaque, Dental White Spot

In brief

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 the development of white spots lesions (the early stage of cavity development). Our study aims to investigate the efficacy of different commercially available fluoride varnishes to treat these white spot lesions after the completion of orthodontic treatment and evaluate their effect on the oral microbiome. Target enrollment is 120 subjects. The study will follow a split-mouth design, with each subject receiving different treatment on the left and right sides of their mouth. The subjects will be randomized into 3 groups, with each group receiving two of the following three options: placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer light-cured fluoride varnish. There will be 4 total visits for this study: Baseline (day 0): Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied T1 (day 30): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T2 (day 90): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T3 (day 180): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, dental cleaning performed Participants will be instructed to use regular fluoridated toothpaste and floss twice per day for the duration of the study.

Key facts

Study ID: NCT04528134
Run by: University of California, Los Angeles
People needed: 38
Starts: 2022-02-07
Expected to finish: 2025-07-01
Last updated by the study team: 2026-07-09

Who can join

Age: 12 and older, up to 27. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

UCLA School of Dentistry — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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