Expired Study
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Redmond, Oregon 97756


Purpose:

This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.


Study summary:

Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.


Criteria:

Inclusion Criteria: - Nyvad criteria 3 - Active carious lesion Exclusion Criteria: - Allergy to silver - Stomatitis or oral ulcerative condition - Weight less than 15 kg


Study is Available At:


Original ID:

003


NCT ID:

NCT02536040


Secondary ID:


Study Acronym:


Brief Title:

Stopping Cavities Study: Diammine Silver Fluoride


Official Title:

Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

24 Months


Maximum Age:

60 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Advantage Dental Services, LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

66


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter Milgrom, DDS
Study Director
Advantage Dental Plans

Study Dates

Start Date:January 2016
Completion Date:July 2016
Completion Type:Actual
Primary Completion Date:July 2016
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 8, 2016
First Received Date:August 27, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Caries activity
Time Frame:14-21 days
Safety Issues:False
Description:Nyvad criterion code 6

Study Interventions

Intervention Type:Drug
Name:38% diammine silver fluoride
Description:treatment of cavity with study agent
Arm Name:38% diamine silver fluoride
Other Name:silver fluoride
Intervention Type:Other
Name:Water
Description:Fluoride free, distilled water
Arm Name:Water

Study Arms

Study Arm Type:Experimental
Arm Name:38% diamine silver fluoride
Description:Topical application of 38% diammine silver fluoride to active cavity
Study Arm Type:Placebo Comparator
Arm Name:Water
Description:Topical application of fluoride free water to active cavity

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Advantage Dental Services, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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