Pharmacokinetics of Advantage Anti-Caries Varnish

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetics of Advantage Anti-Caries Varnish

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Anti-caries varnish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label exposure--response study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-caries varnish<br>topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application | Drug: Anti-caries varnish<br>* topical tooth varnish<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed Iodine Tmax | Time to maximum serum concentration of iodine in hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Iodine Cmax | Maximum serum concentration of iodine in ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Iodine Baseline-Corrected Cmax | Maximum serum concentration of iodine in ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Iodine Baseline-Corrected AUC | Area under the Curve for observed iodine in ng*h/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Iodine Total Urinary Recovery | Total urinary recovery in milligrams observed | baseline to 24 hours | 
| Iodine t1/2 | Terminal elimination half-life of iodine in hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Fluoride Tmax | Time to maximum serum concentration in hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Fluoride Cmax | Maximum serum concentration of fluoride in ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Fluoride Baseline-Corrected Cmax | Maximum serum concentration of iodine in ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Fluoride AUC | Area under the Curve for observed fluoride in ng*h/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Fluoride Baseline-Corrected AUC | Area under the Curve for observed fluoride in ng*h/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Fluoride t1/2 | Terminal elimination half-life in hours for fluoride | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | 
| Observed Fluoride Total Urinary Recovery | Total urinary recovery in milligrams observed | baseline to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults, povidone iodine, sodium fluoride