Phase 2
Completed N=16
Pharmacokinetics of Advantage Anti-Caries Varnish
Source: ClinicalTrials.gov NCT04183231 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Observed Iodine Tmax — 1.7 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Iodine Tmax |
1.7 | — |
| PRIMARY Observed Iodine Cmax |
111 | — |
| PRIMARY Observed Iodine Baseline-Corrected Cmax |
57 | — |
| PRIMARY Observed Iodine Baseline-Corrected AUC |
539 | — |
| PRIMARY Observed Iodine Total Urinary Recovery |
1.26 | — |
| PRIMARY Iodine t1/2 |
5.5 | — |
| PRIMARY Observed Fluoride Tmax |
0.8 | — |
| PRIMARY Observed Fluoride Cmax |
76 | — |
| PRIMARY Observed Fluoride Baseline-Corrected Cmax |
60 | — |
| PRIMARY Observed Fluoride AUC |
703 | — |
| PRIMARY Observed Fluoride Baseline-Corrected AUC |
315 | — |
| PRIMARY Fluoride t1/2 |
3.1 | — |
| PRIMARY Observed Fluoride Total Urinary Recovery |
2.51 | — |
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
Data sourced from ClinicalTrials.gov (NCT04183231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.