Clinical trial NCT04183231: Pharmacokinetics of Advantage Anti-Caries Varnish
Official title: Pharmacokinetics of Advantage Anti-Caries Varnish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: adults
povidone iodine
sodium fluoride
Lead sponsor: Advantage Silver Dental Arrest, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2019-12-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label exposure--response study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Observed Iodine Tmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Iodine Cmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Iodine Baseline-Corrected Cmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Iodine Baseline-Corrected AUC
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Iodine Total Urinary Recovery
timeFrame: baseline to 24 hours
measure: Iodine t1/2
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Fluoride Tmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Fluoride Cmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Fluoride Baseline-Corrected Cmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Fluoride AUC
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Fluoride Baseline-Corrected AUC
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Fluoride t1/2
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Observed Fluoride Total Urinary Recovery
timeFrame: baseline to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington School of Pharmacy
name: Yvonne Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.