Pharmacokinetics of Advantage Arrest

January 11, 2021 updated by: Advantage Silver Dental Arrest, LLC
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Institute of Translational Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 38% silver diamine fluoride
38% silver diamine fluoride, topical, 1 drop, single application
Drug: 38% silver diamine fluoride
Topical application of SDF to teeth
Other Names:
  • Advantage Arrest

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advantage Silver Dental Arrest, LLC

Collaborators

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

November 30, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-11-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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