CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Silver Diamine Fluoridedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04186663
NCT04186663Phase 2Completed

Pharmacokinetics of Advantage Arrest in Children

Advantage Silver Dental Arrest, LLC·interventional·Posted Dec 5, 2019·Updated Mar 10, 2022

In Brief

A Phase 2 clinical trial evaluating Silver Diamine Fluoride for Dental Caries. Completed, enrolled 59 participants across 1 site.

Detailed Summary

The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 5, 2019
Enrollment StartAug 1, 2019
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.6 years ago

Interventions

Silver Diamine Fluoridedrug

38% aqueous silver diamine fluoride \[Ag(NH3)\]2F, CAS RN 33040-28-7