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NCT02536040 Clinical Trial

Stopping Cavities Study: Diammine Silver Fluoride

Dental Caries Clinical Trial

Official title:
Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02536040
Other study ID # 003
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2016
Est. completion date July 2016

Study information
Verified date August 2016
Source Advantage Dental Services, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Months to 60 Months
Eligibility Inclusion Criteria:

- Nyvad criteria 3

- Active carious lesion

Exclusion Criteria:

- Allergy to silver

- Stomatitis or oral ulcerative condition

- Weight less than 15 kg

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 38% diammine silver fluoride
treatment of cavity with study agent
Other:
• Water
Fluoride free, distilled water

Locations
Country Name City State
United States Advantage Dental Plans Redmond Oregon

Sponsors (1)
Lead Sponsor Collaborator
Advantage Dental Services, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dental Caries Activity 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 14-21 days
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