Stopping Cavities Study: Diammine Silver Fluoride
Phase 3
Completed
- Conditions
- Dental Caries
- Interventions
- Drug: 38% diammine silver fluorideOther: Water
- Registration Number
- NCT02536040
- Lead Sponsor
- Advantage Dental Services, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 38% diamine silver fluoride 38% diammine silver fluoride Topical application of 38% diammine silver fluoride to active cavity Water Water Topical application of fluoride free water to active cavity
- Primary Outcome Measures
Name Time Method Dental Caries Activity 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Advantage Dental Plans
🇺🇸Redmond, Oregon, United States