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NCT04528134

Orthodontic Varnish Microbiology Study

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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 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.

Official title: The Effect of Light-cured Fluoride Varnish to Remineralize Post-orthodontic White Spot Lesions and Change the Oral Microbiome: a Double-blind, Split-mouth Randomized Clinical Trial

Key Details

Gender

All

Age Range

12 Years - 27 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-02-07

Completion Date

2025-07-01

Last Updated

2026-07-09

Healthy Volunteers

Yes

Conditions

Dental Caries Dental Plaque Dental White Spot

Interventions

DEVICE

Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish

This is a light-cured, durable coating that forms an immediate layer of protection that releases fluoride, calcium and phosphate and can be recharged with fluoride by using fluoride-containing products over the 6-month life of the product.

DEVICE

5% Sodium Fluoride Varnish

This is a 5% Sodium Fluoride varnish that hardens on the teeth upon contact with saliva.

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).

Locations (1)

UCLA School of Dentistry

Los Angeles, California, United States