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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Advantage Silver Dental Arrest, LLC
• Collaborator: University of Washington
• Treatments: Fluorides

Criteria

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