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Completed

NCT Number: NCT04184271

Pharmacokinetics of Advantage Arrest

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington Institute of Translational Health Sciences

Seattle, Washington, 98195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

38% silver diamine fluoride

Drug

Topical application of SDF to teeth

Other names: Advantage Arrest

Primary outcomes

  1. Observed Fluoride Urinary Recovery

    Time frame: baseline to 24 hours

    24 hour fluoride urinary recovery (in mg)

  2. 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

  3. 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

  4. 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

  5. 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

  6. Observed Silver 24 Hour Urinary Concentration

    Time frame: baseline to 24 hours

    Observed silver 24-hour urinary concentration in ng/mL

Sponsors and collaborators

Lead sponsor

Advantage Silver Dental Arrest, LLC

Industry

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Dec 3, 2019
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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