NCT05670743

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Advantage Silver Dental Arrest, LLC · Industry
• Sex: All
• Age: 13 Months – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
DRUG	38% silver diamine fluoride	Topical application of 38% silver diamine fluoride to dental caries lesions

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-06-10
• Completion: 2024-08-01
• First posted: 2023-01-04
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study