Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Drug: 38% silver diamine fluoride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Months
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver diamine fluoride<br>Silver diamine fluoride, 38%, topical, single application | Drug: 38% silver diamine fluoride<br>* Topical application of 38% silver diamine fluoride to dental caries lesions<br>* Other names: Advantage Silver Arrest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoride Cmax | Maximum serum concentration of fluoride | 21 days | 
| Silver Cmax | Maximum serum concentration of silver | 21 days | 
| Fluoride Tmax | Time to maximum serum concentration of fluoride | 21 days | 
| Silver Tmax | Time to maximum serum concentration of silver | 21 days | 
| Area Under Curve, Fluoride | Area under the curve, fluoride | 21 days | 
| Area Under Curve, Silver | Area under the curve, silver | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics