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

NCT05670743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-08-06

No results posted yet for this study

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.

Conditions

  • Dental Caries in Children

Interventions

DRUG

38% silver diamine fluoride

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

Sponsors & Collaborators

Principal Investigators

  • Travis Nelson, DDS · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Months
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-06-10
Completion
2024-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670743 on ClinicalTrials.gov