Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
- Registration Number
- NCT05670743
- Lead Sponsor
- Advantage Silver Dental Arrest, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- At least one untreated caries lesion into the dentin
- Live within 10 miles of study site
- oral mucositis
- ulcerative oral lesions
- hypersensitivity to silver or fluoride
- history of treatment with silver diamine fluoride within 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Silver diamine fluoride 38% silver diamine fluoride Silver diamine fluoride, 38%, topical, single application
- Primary Outcome Measures
Name Time Method Fluoride Cmax 21 days Maximum serum concentration of fluoride
Fluoride Tmax 21 days Time to maximum serum concentration of fluoride
Area Under Curve, Fluoride 21 days Area under the curve, fluoride
Area Under Curve, Silver 21 days Area under the curve, silver
Silver Cmax 21 days Maximum serum concentration of silver
Silver Tmax 21 days Time to maximum serum concentration of silver
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Pediatric Dentistry
🇺🇸Seattle, Washington, United States