Dental Caries in Children
Conditions
Keywords
pharmacokinetics
Brief summary
The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.
Detailed description
The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.
Interventions
Topical application of 38% silver diamine fluoride to dental caries lesions
Sponsors
University of Washington
Advantage Silver Dental Arrest, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest.
Eligibility
Sex/Gender
ALL
Age
13 Months to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* At least one untreated caries lesion into the dentin * Live within 10 miles of study site
Exclusion criteria
* oral mucositis * ulcerative oral lesions * hypersensitivity to silver or fluoride * history of treatment with silver diamine fluoride within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluoride Cmax | 21 days | Maximum serum concentration of fluoride |
| Silver Cmax | 21 days | Maximum serum concentration of silver |
| Fluoride Tmax | 21 days | Time to maximum serum concentration of fluoride |
| Silver Tmax | 21 days | Time to maximum serum concentration of silver |
| Area Under Curve, Fluoride | 21 days | Area under the curve, fluoride |
| Area Under Curve, Silver | 21 days | Area under the curve, silver |
Countries
United States
Outcome results
None listed