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

Advantage Silver Dental Arrest

Status and phase: Completed; Phase 2

Conditions: Dental Caries in Children

Treatments: Drug: 38% silver diamine fluoride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05670743

SDF PK WCGIRB-v1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 13 months to 13 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Silver diamine fluoride

Experimental group

Description:

Silver diamine fluoride, 38%, topical, single application

Treatment:

Drug: 38% silver diamine fluoride