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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05670743
• Other study ID #: SDF PK WCGIRB-v1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Advantage Silver Dental Arrest, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: April 2024
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Months to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• 38% silver diamine fluoride
Topical application of 38% silver diamine fluoride to dental caries lesions

Locations

Country	Name	City	State
United States	Center for Pediatric Dentistry	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Advantage Silver Dental Arrest, LLC	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluoride Cmax	Maximum serum concentration of fluoride	21 days
Primary	Silver Cmax	Maximum serum concentration of silver	21 days
Primary	Fluoride Tmax	Time to maximum serum concentration of fluoride	21 days
Primary	Silver Tmax	Time to maximum serum concentration of silver	21 days
Primary	Area Under Curve, Fluoride	Area under the curve, fluoride	21 days
Primary	Area Under Curve, Silver	Area under the curve, silver	21 days