At a glance
ClinicalIndex Comparison RecordPhase 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.
Pharmacokinetics of Advantage Arrest in Children
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
CollaboratorsUniversity of California, San Francisco
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedDec 2019
Primary CompletionMar 2020
TodayJul 2026
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