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

Sponsor
Advantage Silver Dental Arrest, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05670743
Collaborator
University of Washington (Other)
30
Enrollment
1
Location
1
Arm
6
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 38% silver diamine fluoride
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest.This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fluoride Cmax [21 days]

      Maximum serum concentration of fluoride

    2. Silver Cmax [21 days]

      Maximum serum concentration of silver

    3. Fluoride Tmax [21 days]

      Time to maximum serum concentration of fluoride

    4. Silver Tmax [21 days]

      Time to maximum serum concentration of silver

    5. Area Under Curve, Fluoride [21 days]

      Area under the curve, fluoride

    6. Area Under Curve, Silver [21 days]

      Area under the curve, silver

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Months to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Pediatric Dentistry Seattle Washington United States 98195

    Sponsors and Collaborators

    • Advantage Silver Dental Arrest, LLC
    • University of Washington

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Advantage Silver Dental Arrest, LLC
    ClinicalTrials.gov Identifier:
    NCT05670743
    Other Study ID Numbers:
    • SDF PK WCGIRB-v1
    First Posted:
    Jan 4, 2023
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Advantage Silver Dental Arrest, LLC
    pharmacokinetics
    Additional relevant MeSH terms:
    Dental Caries
    Fluorides

    Study Results

    No Results Posted as of Jan 4, 2023