Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
Overview
- Phase
- Phase 3
- Intervention
- Water
- Conditions
- Dental Caries
- Sponsor
- Advantage Dental Services, LLC
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Dental Caries Activity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Nyvad criteria 3
- •Active carious lesion
Exclusion Criteria
- •Allergy to silver
- •Stomatitis or oral ulcerative condition
- •Weight less than 15 kg
Arms & Interventions
Water
Topical application of fluoride free water to active cavity
Intervention: Water
38% diamine silver fluoride
Topical application of 38% diammine silver fluoride to active cavity
Intervention: 38% diammine silver fluoride
Outcomes
Primary Outcomes
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