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

SDF PK WCGIRB-v1

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.

2023-03-01

2023-06-10

2024-04-01

Active (not recruiting)

Early phase I

23

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}

2024-01-30