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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05670743
Other study ID # SDF PK WCGIRB-v1
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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