Skip to main content
OpenTrials
Completed

NCT Number: NCT05670743

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Caries in Children

Age range

13 month–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Pediatric Dentistry

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

38% silver diamine fluoride

Drug

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

Other names: Advantage Silver Arrest

Primary outcomes

  1. Fluoride Cmax

    Time frame: 21 days

    Maximum serum concentration of fluoride

  2. Silver Cmax

    Time frame: 21 days

    Maximum serum concentration of silver

  3. Fluoride Tmax

    Time frame: 21 days

    Time to maximum serum concentration of fluoride

  4. Silver Tmax

    Time frame: 21 days

    Time to maximum serum concentration of silver

  5. Area Under Curve, Fluoride

    Time frame: 21 days

    Area under the curve, fluoride

  6. Area Under Curve, Silver

    Time frame: 21 days

    Area under the curve, silver

Sponsors and collaborators

Lead sponsor

Advantage Silver Dental Arrest, LLC

Industry

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 4, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.