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Fluoride Varnishes for Dental White Spots

N/A

Recruiting

Led By Tyler Brennan, DDS

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is investigating the efficacy of different fluoride varnishes to treat white spot lesions after orthodontic treatment.

Who is the study for?

This study is for healthy teens aged 12-17 nearing the end of orthodontic treatment with metal braces and having at least two white spot lesions on their teeth. They must use only standard oral care products, agree to specific dental cleaning schedules, and follow diet instructions throughout the study.Check my eligibility

What is being tested?

The trial tests how effective different fluoride varnishes are in treating white spots on teeth after braces. It's a split-mouth design where each participant gets different treatments on either side of their mouth, comparing placebo, sodium fluoride varnish, and resin-modified glass ionomer varnish.See study design

What are the potential side effects?

Potential side effects may include irritation or allergic reactions in the mouth from the varnishes used. However, these treatments are generally considered safe and such reactions are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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I agree to use only a manual toothbrush and sodium fluoride toothpaste during the study.

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I have at least two visible white spots on my teeth with braces.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

White Spot Lesion severity

Secondary outcome measures

Dental Plaque Levels

Microbiome Composition

Plaque and Saliva Microbial Colonization

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Placebo Varnish/Extended Contact RMGI VarnishExperimental Treatment1 Intervention

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.

Group II: Extended Contact RMGI Varnish/5% Sodium Fluoride VarnishExperimental Treatment2 Interventions

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.

Group III: 5% Sodium Fluoride Varnish/Placebo VarnishActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5% Sodium Fluoride Varnish

2016

Completed Phase 4

~130

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,082 Total Patients Enrolled

Tyler Brennan, DDSPrincipal InvestigatorUniversity of California, Los Angeles

Nini Tran, DDS, PhDStudy DirectorUniversity of California, Los Angeles

Media Library

Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish Clinical Trial Eligibility Overview. Trial Name: NCT04528134 — N/A

Dental White Spots Research Study Groups: Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish, Placebo Varnish/Extended Contact RMGI Varnish, 5% Sodium Fluoride Varnish/Placebo Varnish

Dental White Spots Clinical Trial 2023: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish Highlights & Side Effects. Trial Name: NCT04528134 — N/A

Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish 2023 Treatment Timeline for Medical Study. Trial Name: NCT04528134 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining this clinical trial?

"Indeed, the information on clinicaltrials.gov attests to this trial's active recruitment status. The first post was made on February 5th 2022 and it has been recently updated as of January 21st 2022 for a total requirement of 120 participants at 1 site."

Answered by AI

Are geriatric individuals being enrolled in this clinical trial?

"In order to be qualified for this medical study, potential participants must have a minimum age of 12 and an upper limit of 19."

Answered by AI

Are there still opportunities to enroll in this experiment?

"Clinicaltrials.gov confirms that this trial is actively looking for participants, with recruitment commencing on February 5th 2022 and the details of the study being recently revised on January 21st 2022."

Answered by AI