Pharmacokinetics of Advantage Arrest

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Drug: 38% silver diamine fluoride

• Registration Number: NCT04184271
• Lead Sponsor: Advantage Silver Dental Arrest, LLC

Brief Summary

The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

Detailed Description

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

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2017-09-30
• Study Completion: 2019-03-31
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-30
• Study First Posted: 2019-12-03
• Status Verified: 2020-07
• Results First Submitted: 2020-07-07
• Results First Submitted QC: 2020-07-31
• Results First Posted: 2020-08-14
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications

Exclusion Criteria

• pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
38% silver diamine fluoride	38% silver diamine fluoride	38% silver diamine fluoride, topical, 1 drop, single application

Primary Outcome Measures

Name	Time	Method
Observed Fluoride Urinary Recovery	baseline to 24 hours	24 hour fluoride urinary recovery (in mg)
Observed Silver Tmax	baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours	Observed silver time to maximum serum concentration in hours
Observed Silver Cmax	baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours	Observed silver maximum serum concentration in ng/mL
Observed Silver Baseline-Corrected Cmax	baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours	Observed silver baseline-corrected maximum serum concentration in ng/mL
Observed Silver t1/2	baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours	Observed silver serum elimination half-life in hours
Observed Silver 24 Hour Urinary Concentration	baseline to 24 hours	Observed silver 24-hour urinary concentration in ng/mL

Trial Locations

Locations (1)

University of Washington Institute of Translational Health Sciences; 🇺🇸 Seattle, Washington, United States