N/A
N=41
Silver Diamine Fluoride Pilot Study (SDF)
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02591147 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Assessment of Radiographic Change in Dental Cavity — 9; 11; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silver Diamine Fluoride 38% (Device); Group 2 (Placebo) (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Justine Kolker
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Radiographic Change in Dental Cavity |
9; 11; 3; 2; 6; 3 | — |
Summary
This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.
Eligibility Criteria
Inclusion Criteria
- Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and molars) presented with full contact with the adjacent tooth.
- All the surfaces eligible for this study will be included.
Exclusion Criteria
- The approximal lesion detected in the radiograph has advanced dentine lesion (RB4, RC5, or RC6)
- or is adjacent to a lesion that is either filled or will receive a filling at the time of enrollment.
Data sourced from ClinicalTrials.gov (NCT02591147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.