Title
Stopping Cavities Study: Diammine Silver Fluoride
Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
Phase
Phase 3Lead Sponsor
Advantage DentalStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dental CariesIntervention/Treatment
silver diammine fluoride ...Study Participants
66This 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.
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.
treatment of cavity with study agent
Fluoride free, distilled water
Topical application of 38% diammine silver fluoride to active cavity
Inclusion Criteria: Nyvad criteria 3 Active carious lesion Exclusion Criteria: Allergy to silver Stomatitis or oral ulcerative condition Weight less than 15 kg
| Event Type | Organ System | Event Term |
|---|
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
