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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Anti-caries varnish

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Advantage Silver Dental Arrest, LLC
• Collaborators: University of Washington
• Investigators: Principal Investigator: Yvonne Lin, PhD, University of Washington School of Pharmacy

Publications and helpful links

General Publications

• Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of Iodine and Fluoride following Application of an Anticaries Varnish in Adults. JDR Clin Trans Res. 2018 Jul;3(3):238-245. doi: 10.1177/2380084418771930. Epub 2018 Apr 25.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 30, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: adults; sodium fluoride; povidone iodine
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 2016-04-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO