Pharmacokinetics of Advantage Anti-Caries Varnish

Dental Caries Clinical Trial

Official title:

Pharmacokinetics of Advantage Anti-Caries Varnish

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183231
• Other study ID #: 2016-04-05
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2016
• Est. completion date: April 25, 2018

Study information

• Verified date: July 2020
• Source: Advantage Silver Dental Arrest, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 25, 2018
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Anti-caries varnish
topical tooth varnish

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Advantage Silver Dental Arrest, LLC	University of Washington

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Observed Iodine Total Urinary Recovery	Total urinary recovery in milligrams observed	baseline to 24 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Observed Fluoride Total Urinary Recovery	Total urinary recovery in milligrams observed	baseline to 24 hours