Dental Caries
Conditions
Keywords
silver diamine fluoride, diammine silver fluoride, children
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.
Interventions
DRUG38% diammine silver fluoride
treatment of cavity with study agent
OTHERWater
Fluoride free, distilled water
Sponsors
Advantage Dental Services, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 60 Months
Healthy volunteers
Yes
Inclusion criteria
* Nyvad criteria 3 * Active carious lesion
Exclusion criteria
* Allergy to silver * Stomatitis or oral ulcerative condition * Weight less than 15 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 38% Diamine Silver Fluoride Topical application of 38% diammine silver fluoride to active cavity
38% diammine silver fluoride: treatment of cavity with study agent | 30 |
| Water Topical application of fluoride free water to active cavity
Water: Fluoride free, distilled water | 36 |
| Total | 66 |
Baseline characteristics
| Characteristic | 38% Diamine Silver Fluoride | Total | Water |
|---|---|---|---|
| Age, Continuous | 4.7 years STANDARD_DEVIATION 0.6 | 4.8 years STANDARD_DEVIATION 0.6 | 4.9 years STANDARD_DEVIATION 0.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 38 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 26 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 60 Participants | 33 Participants |
| Region of Enrollment United States | 29 participants | 64 participants | 35 participants |
| Sex: Female, Male Female | 13 Participants | 31 Participants | 18 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 35 |
| other Total, other adverse events | 0 / 29 | 0 / 35 |
| serious Total, serious adverse events | 0 / 29 | 0 / 35 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 38% Diamine Silver Fluoride | Dental Caries Activity | .72 Proportion of arrested caries lesions | Standard Deviation 0.38 |
| Water | Dental Caries Activity | .05 Proportion of arrested caries lesions | Standard Deviation 0.18 |