Stopping Cavities Study: Diammine Silver Fluoride
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02536040 |
Recruitment Status :
Completed
First Posted : August 31, 2015
Results First Posted : January 23, 2020
Last Update Posted : January 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Dental Caries | Drug: 38% diammine silver fluoride Other: Water | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: 38% diamine silver fluoride
Topical application of 38% diammine silver fluoride to active cavity
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Drug: 38% diammine silver fluoride
treatment of cavity with study agent
Other Names:
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Placebo Comparator: Water
Topical application of fluoride free water to active cavity
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Other: Water
Fluoride free, distilled water |
- Dental Caries Activity [ Time Frame: 14-21 days ]Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change

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Ages Eligible for Study: | 24 Months to 60 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Nyvad criteria 3
- Active carious lesion
Exclusion Criteria:
- Allergy to silver
- Stomatitis or oral ulcerative condition
- Weight less than 15 kg

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536040
United States, Oregon | |
Advantage Dental Plans | |
Redmond, Oregon, United States, 97756 |
Study Director: | Peter Milgrom, DDS | Advantage Dental Plans |
Responsible Party: | Advantage Dental Services, LLC |
ClinicalTrials.gov Identifier: | NCT02536040 |
Other Study ID Numbers: |
003 |
First Posted: | August 31, 2015 Key Record Dates |
Results First Posted: | January 23, 2020 |
Last Update Posted: | January 23, 2020 |
Last Verified: | August 2016 |
silver diamine fluoride diammine silver fluoride children |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs |