Orthodontic Varnish Microbiology Study

NCT04528134 | Completed FDA Device

• 1 other identifier: IRB#20-001077
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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

Keywords

Orthodontics

Outcome Measures

Primary Outcomes (1)

• White Spot Lesion severity

  Assessed change in severity of white spots on the teeth as measured by the DiagnoDent, which uses quantitative light-induced fluorescence to assess the depth/severity of enamel demineralization.

  6 months

Secondary Outcomes (8)

• Dental Plaque Levels

  6 months

• Microbiome Composition

  6 months

• Plaque and Saliva Microbial Colonization

  6 months

• White Spot Lesion Clinical Appearance

  6 months

• Salivary flow rate

  6 months

Study Arms (3)

Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish

EXPERIMENTAL

This group will receive extended contact (XT) varnish on their upper left and lower right teeth, and traditional 5% sodium fluoride varnish on their upper right and lower left teeth.

Device: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish; Device: 5% Sodium Fluoride Varnish

Placebo Varnish/Extended Contact RMGI Varnish

EXPERIMENTAL

This group will receive placebo varnish on their upper left and lower right teeth, and extended contact (XT) varnish on their upper right and lower left teeth.

Device: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish

5% Sodium Fluoride Varnish/Placebo Varnish

ACTIVE COMPARATOR

This group will receive traditional 5% sodium fluoride varnish on their upper left and lower right teeth, and placebo varnish on their upper right and lower left teeth.

Device: 5% Sodium Fluoride Varnish

Interventions

Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish DEVICE

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.

Also known as: 3M™ Vanish™ XT Extended Contact Varnish

Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish; Placebo Varnish/Extended Contact RMGI Varnish

5% Sodium Fluoride Varnish DEVICE

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

Also known as: Henry Schein Acclean 5% Sodium Fluoride Varnish

5% Sodium Fluoride Varnish/Placebo Varnish; Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish

Eligibility Criteria

• Age: 12 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Dentistry

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• Klaus K, Eichenauer J, Sprenger R, Ruf S. Oral microbiota carriage in patients with multibracket appliance in relation to the quality of oral hygiene. Head Face Med. 2016 Oct 28;12(1):28. doi: 10.1186/s13005-016-0125-x.

  PMID: 27793169 BACKGROUND

• Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.

  PMID: 24945514 BACKGROUND

• Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.

  PMID: 26759794 BACKGROUND

• Tasios T, Papageorgiou SN, Papadopoulos MA, Tsapas A, Haidich AB. Prevention of orthodontic enamel demineralization: A systematic review with meta-analyses. Orthod Craniofac Res. 2019 Nov;22(4):225-235. doi: 10.1111/ocr.12322. Epub 2019 May 27.

  PMID: 31081584 BACKGROUND

• Mehta A, Paramshivam G, Chugh VK, Singh S, Halkai S, Kumar S. Effect of light-curable fluoride varnish on enamel demineralization adjacent to orthodontic brackets: an in-vivo study. Am J Orthod Dentofacial Orthop. 2015 Nov;148(5):814-20. doi: 10.1016/j.ajodo.2015.05.022.

  PMID: 26522042 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Study Officials

• Tyler Brennan, DDS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Renate Lux, PhD

  University of California, Los Angeles

  STUDY CHAIR

• Nini Tran, DDS, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which interventions they receive. The investigator, who will be providing the treatment, will be aware of which treatments they are receiving (the investigator is impossible to mask due to the different applications of the treatment interventions). Outcomes assessors will be masked and score outcomes based on photos and microbiological data that is de-identified.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontic Resident

Model Details: Subjects will be randomized into one of 3 groups, each of which will receive two of the following three interventions: extended contact varnish, traditional fluoride varnish, placebo varnish. Subjects will receive the interventions in a split-mouth design, with one treatment on half of their teeth and another treatment on the other half of their teeth.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: August 27, 2020
• Study Start: February 7, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)