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Completed

NCT Number: NCT04183231

Pharmacokinetics of Advantage Anti-Caries Varnish

The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.

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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

About this study

The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.

Exclusion criteria

  • Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis

Treatment and study plan

Anti-caries varnish

Drug

topical tooth varnish

Primary outcomes

  1. Observed Iodine Tmax

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Time to maximum serum concentration of iodine in hours

  2. Observed Iodine Cmax

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Maximum serum concentration of iodine in ng/mL

  3. Observed Iodine Baseline-Corrected Cmax

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Maximum serum concentration of iodine in ng/mL

  4. Observed Iodine Baseline-Corrected AUC

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Area under the Curve for observed iodine in ng*h/mL

  5. Observed Iodine Total Urinary Recovery

    Time frame: baseline to 24 hours

    Total urinary recovery in milligrams observed

  6. Iodine t1/2

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Terminal elimination half-life of iodine in hours

  7. Observed Fluoride Tmax

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Time to maximum serum concentration in hours

  8. Observed Fluoride Cmax

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Maximum serum concentration of fluoride in ng/mL

  9. Observed Fluoride Baseline-Corrected Cmax

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Maximum serum concentration of iodine in ng/mL

  10. Observed Fluoride AUC

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Area under the Curve for observed fluoride in ng*h/mL

  11. Observed Fluoride Baseline-Corrected AUC

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Area under the Curve for observed fluoride in ng*h/mL

  12. Fluoride t1/2

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

    Terminal elimination half-life in hours for fluoride

  13. Observed Fluoride Total Urinary Recovery

    Time frame: baseline to 24 hours

    Total urinary recovery in milligrams observed

Sponsors and collaborators

Lead sponsor

Advantage Silver Dental Arrest, LLC

Industry

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 3, 2019
Registry last updated
Aug 21, 2020

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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