Orthodontic Varnish Microbiology Study

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.

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.

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Tyler Brennan, DDS · University of California, Los Angeles

• Renate Lux, PhD · University of California, Los Angeles

• Nini Tran, DDS, PhD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

27 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-07

Primary Completion

2025-07-01

Completion

2025-07-01

FDA Device

Yes

Countries

• United States

Study Locations