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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
topical tooth varnish
Observed Iodine Tmax
Time to maximum serum concentration of iodine in hours
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to 24 hours
Iodine t1/2
Terminal elimination half-life of iodine in hours
Time frame: 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
Time frame: 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
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride Baseline-Corrected Cmax
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Maximum serum concentration of iodine in ng/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to 24 hours