Pharmacokinetics of Advantage Anti-Caries Varnish

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Drug: Anti-caries varnish

• Registration Number: NCT04183231
• Lead Sponsor: Advantage Silver Dental Arrest, LLC

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-02-28
• Study Completion: 2018-04-25
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-30
• Study First Posted: 2019-12-03
• Status Verified: 2020-07
• Results First Submitted: 2020-07-10
• Results First Submitted QC: 2020-07-31
• Last Update Submitted: 2020-07-31
• Results First Posted: 2020-08-21
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-caries varnish	Anti-caries varnish	topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application

Primary Outcome Measures

Name	Time	Method
Observed Fluoride AUC	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
Observed Fluoride Baseline-Corrected AUC	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
Fluoride t1/2	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Terminal elimination half-life in hours for fluoride
Observed Fluoride Total Urinary Recovery	baseline to 24 hours	Total urinary recovery in milligrams observed
Observed Iodine Tmax	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Time to maximum serum concentration of iodine in hours
Observed Iodine Cmax	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Maximum serum concentration of iodine in ng/mL
Observed Iodine Baseline-Corrected Cmax	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Maximum serum concentration of iodine in ng/mL
Observed Iodine Baseline-Corrected AUC	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
Observed Iodine Total Urinary Recovery	baseline to 24 hours	Total urinary recovery in milligrams observed
Iodine t1/2	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Terminal elimination half-life of iodine in hours
Observed Fluoride Tmax	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Time to maximum serum concentration in hours
Observed Fluoride Cmax	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Maximum serum concentration of fluoride in ng/mL
Observed Fluoride Baseline-Corrected Cmax	0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose	Maximum serum concentration of iodine in ng/mL