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Silver Diamine Fluoride for Cavities

Phase 3
Waitlist Available
Led By Margherita Fontana, DDS, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, between 12-71 months of age at baseline, up to the day the child turns 6 years old.
Must allow examination of the oral cavity and application of treatment by the examiners at baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24-48 hour call, 1.5 month, 3 month, 4.5 month, 6 month, 24-48 hours after 6 month, 7 month, 8 month
Awards & highlights

Study Summary

This trial is to see if a new drug, SDF, can help prevent cavities in children's teeth better than the current standard, placebo.

Eligible Conditions
  • Cavities

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are a boy or a girl who is between 12 months and 71 months old at the start of the study. You can't be older than 6 years old during the study.
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You need to let the examiners examine your mouth and provide any necessary treatment at the beginning of the trial.
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Children must have signs of tooth decay, such as cavities or lesions, on any tooth surface for those under 3 years old. Children between 3 and 5 years old must have decay in their front teeth or a certain score on a dental exam.
Select...
You have a tooth that needs treatment for gum disease.
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You have severe tooth decay that has reached the inner layer of your tooth (dentin).
Select...
You have a cavity that is big enough to apply medication and can be easily accessed by the microbrush applicator.
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You and your child need to agree in writing before your child can participate.
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You must be 18 years old or older, or a minor who has legal documentation of being independent.
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You are able and willing to take part in all aspects of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24-48 hour call, 1.5 month, 3 month, 4.5 month, 6 month, 24-48 hours after 6 month, 7 month, 8 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24-48 hour call, 1.5 month, 3 month, 4.5 month, 6 month, 24-48 hours after 6 month, 7 month, 8 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of arrested trial lesions per child in each treatment arm after one treatment with SDF or Placebo
Secondary outcome measures
Change in proportion of arrested trial lesions per child in each treatment arm after one treatment with SDF or Placebo
Pain
The proportion of arrested trial lesions per child in each treatment arm after two treatments with SDF or Placebo

Side effects data

From 2020 Phase 3 trial • 98 Patients • NCT02601833
45%
Active (soft) Lesion
13%
Active (soft) Lesion with Progression
7%
Radiographic signs of periapical infection
5%
Reversible Pulpitis
5%
Extraction
5%
Hard (arrested) Lesion with Progression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Silver Diamine Fluoride
Conventional Caries Management

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Silver Diamine Fluoride (SDF)Experimental Treatment1 Intervention
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Group II: PlaceboPlacebo Group1 Intervention
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Silver Diamine Fluoride
2019
Completed Phase 3
~8880

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,782 Previous Clinical Trials
6,363,826 Total Patients Enrolled
NYU Langone HealthOTHER
1,359 Previous Clinical Trials
816,382 Total Patients Enrolled
University of IowaOTHER
444 Previous Clinical Trials
877,879 Total Patients Enrolled

Frequently Asked Questions

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

If Silver Diamine Fluoride is used, are there any risks associated with it?

"There is some evidence to support the efficacy of silver diamine fluoride, as well as multiple rounds of data affirming its safety. Consequently, our team has rated it a 3 on our safety scale."

Answered by AI

Are participants in this research project required to be under a certain age?

"The age bracket for this study includes anyone who is over 1 year old, but under 6 years old."

Answered by AI

To whom is this scientific research available?

"This particular clinical trial is looking for 831 participants that meet the following criteria: they must have teeth and be between 12 and 71 months old."

Answered by AI

Are we still able to enroll new patients in this clinical trial?

"The trial in question is not currently enrolling new patients, as indicated by the clinicaltrials.gov website. The most recent update to the posting was on October 5th, 2022. There are, however, 105 other clinical trials that are recruiting patients."

Answered by AI
~130 spots leftby Mar 2025