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Anti-caries agent

5% Fluoride Varnish for Tooth Decay

Phase 3

Recruiting

Led By Lisa Carrington, DDS

Research Sponsored by Lisa Carrington

Eligibility Criteria Checklist

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

Must have

ASA I and ASA II children, aged 3-12

Behavior of 3 or 4 on Frankl scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial looks at the effectiveness of using silver diamine fluoride (SDF) to stop or reverse tooth decay in primary teeth, and whether using SDF with Super Floss is more effective than using SDF alone or fluoride varnish alone.

Eligible Conditions

Tooth Decay

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Interproximal caries zone of radiolucency

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: SDF without Super FlossExperimental Treatment2 Interventions

SDF will be applied to around the (buccal, lingual, and occlusal) embrasures of the target interproximal lesions with the use of a microbrush for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.

Group II: SDF with Super FlossExperimental Treatment3 Interventions

SDF will be applied to target interproximal lesions with the use of Super Floss for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.

Group III: Fluoride Varnish aloneActive Control1 Intervention

5% sodium fluoride varnish will be applied to all teeth the day of acceptance into the study and then at 3 months, 6 months, and 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Floss

2019

N/A

~130

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lisa CarringtonLead Sponsor

Brian Lee, DDSLead Sponsor

Stephanie ShimizuLead Sponsor

Frequently Asked Questions

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

What is the official government stance on 5% Fluoride Varnish?

"There is both efficacy and safety data available for 5% Fluoride Varnish, which has been collected over multiple Phase 3 clinical trials. Consequently, our team has given it a safety score of 3."

Answered by AI

If a patient is over 20 years old, are they eligible for this program?

"Children who meet the age requirements of 3 to 12 years old are welcome to apply for this clinical trial. Out of the 57 clinical trials taking place that involve patients under 18, this is one of the 30 trials for patients over the age of 65."

Answered by AI

How can I join this test group for the medication?

"Sixty children with dental caries, aged 3-12, are being accepted into this clinical trial. The most important requirements for applicants are as follows: They must be ASA I or ASA II, They must score a 3 or 4 on the Frankl scale, They must have radiographic decay within enamel or extending to the dentin-enamel junction based on ICCMS Categories 1, 2 and 3 "Initial stages", The target interproximal lesion cannot have an existing restoration, recurrent decay, or adjacent teeth with existing restorations."

Answered by AI

Are there any more slots available for participants in this experiment?

"That is accurate. Currently, the clinical trial is recruiting 60 participants at 1 location, as reflected on the most recent update on clinicaltrials.gov (posted on 2022-08-06)."

Answered by AI

Could you please tell me how many people are currently enrolled in this experiment?

"The clinicaltrials.gov website says that this trial is currently looking for enrollees. This study was originally posted on 2019-01-22 and was most recently updated on 2022-08-06. They are hoping to have 60 people sign up at 1 location."

Answered by AI

Recent research and studies

Journal of Dental ResearchJournal

Silver Diamine Fluoride: A Caries “silver-fluoride Bullet

Rosenblatt, A., T.C.M. Stamford, and R. Niederman. 2009. “Silver Diamine Fluoride: A Caries “silver-fluoride Bullet””. Journal of Dental Research. SAGE Publications. doi:10.1177/0022034508329406.

Plos OneJournal

Silver Diamine Fluoride and Oral Health-related Quality of Life: A Review and Network Meta-analysis

Ruff, Ryan Richard, Rachel Whittemore, Martyna Grochecki, Jillian Bateson, and Tamarinda J. Barry Godín. 2022. “Silver Diamine Fluoride and Oral Health-related Quality of Life: A Review and Network Meta-analysis”. Edited by Richard Johannes Wierichs. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0261627.

clinicaltrials.govStudy

Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride

Stephanie Shimizu 2019. "Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03770286.