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

August 5, 2024 updated by: Advantage Silver Dental Arrest, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • Center for Pediatric Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver diamine fluoride
Silver diamine fluoride, 38%, topical, single application
Drug: 38% silver diamine fluoride
Topical application of 38% silver diamine fluoride to dental caries lesions
Other Names:
  • Advantage Silver Arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoride Cmax
Time Frame: 21 days
Maximum serum concentration of fluoride
21 days
Silver Cmax
Time Frame: 21 days
Maximum serum concentration of silver
21 days
Fluoride Tmax
Time Frame: 21 days
Time to maximum serum concentration of fluoride
21 days
Silver Tmax
Time Frame: 21 days
Time to maximum serum concentration of silver
21 days
Area Under Curve, Fluoride
Time Frame: 21 days
Area under the curve, fluoride
21 days
Area Under Curve, Silver
Time Frame: 21 days
Area under the curve, silver
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advantage Silver Dental Arrest, LLC

Collaborators

University of Washington

Investigators

  • Principal Investigator: Travis Nelson, DDS, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

June 10, 2023

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDF PK WCGIRB-v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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