A Phase 3 interventional study of 38% diammine silver fluoride and Water in Dental Caries, sponsored by Advantage Dental Services, LLC. Completed at 1 site in United States. Open to participants aged 24 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Advantage Dental Services, LLC · Phase 3, Interventional, and Treatment
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.
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.
1,107 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 66 is close to the median of 60 across 915 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Advantage Dental Services, LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical application of 38% diammine silver fluoride to active cavity
Drug: 38% diammine silver fluoride
Topical application of fluoride free water to active cavity
Other: Water
treatment of cavity with study agent
Also known as: silver fluoride, silver diamine fluoride
Fluoride free, distilled water
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
Time frame: 14-21 days
| Milestone | 38% Diamine Silver Fluoride | Water |
|---|---|---|
| Started | 30 | 36 |
| Completed | 29 | 35 |
| Not completed | 1 | 1 |
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
| Proportion of arrested caries lesions | 38% Diamine Silver Fluoride | Water |
|---|---|---|
| Dental Caries Activity | .72 ± .38 | .05 ± .18 |
Collected over The primary focus of the adverse events clinical examination was to detect intramural soft tissue changes 2 days following the localized treatment of the teeth. It was not measured 14-21 days later when the primary outcome was assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 38% Diamine Silver Fluoride | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Water | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Continuous(years) | 38% Diamine Silver Fluoride | Water | Total |
|---|---|---|---|
| Mean | 4.7 ± .6 | 4.9 ± .5 | 4.8 ± .6 |
| Sex: Female, Male(Participants) | 38% Diamine Silver Fluoride | Water | Total |
|---|---|---|---|
| Female | 13 | 18 | 31 |
| Male | 16 | 17 | 33 |
| Ethnicity (NIH/OMB)(Participants) | 38% Diamine Silver Fluoride | Water | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 23 | 38 |
| Not Hispanic or Latino | 14 | 12 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 38% Diamine Silver Fluoride | Water | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 27 | 33 | 60 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 38% Diamine Silver Fluoride | Water | Total |
|---|---|---|---|
| United States | 29 | 35 | 64 |
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Advantage Dental Services, LLC