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CompletedNCT04183231Updated Aug 21, 2020Results posted

Pharmacokinetics of Advantage Anti-Caries Varnish

A Phase 2 interventional study of Anti-caries varnish in Dental Caries, sponsored by Advantage Silver Dental Arrest, LLC. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by Advantage Silver Dental Arrest, LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Nov 2016, registered Nov 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries

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Keywords

  • adults
  • povidone iodine
  • sodium fluoride
03

In context

Dental Caries

1,107 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 16 is below the median of 60 across 915 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Advantage Silver Dental Arrest, LLC is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

Interventions

  • DrugAnti-caries varnish

    topical tooth varnish

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Observed Iodine Total Urinary Recovery

    Total urinary recovery in milligrams observed

    Time frame: baseline to 24 hours

  6. 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

  7. 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

  8. 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

  9. Observed Fluoride 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

  10. 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

  11. 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

  12. 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

  13. Observed Fluoride Total Urinary Recovery

    Total urinary recovery in milligrams observed

    Time frame: baseline to 24 hours

07

Results

Posted Aug 21, 2020

Participant flow

Participant flow — Overall Study
MilestoneAnti-caries Varnish
Started16
Completed16
Not completed0

Outcome measures

PrimaryObserved 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
Reported as:
Mean · hours
Observed Iodine Tmax
hoursAnti-caries Varnish
Observed Iodine Tmax1.7 ± 0.7
PrimaryObserved 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
Reported as:
Mean · ng/mL
Observed Iodine Cmax
ng/mLAnti-caries Varnish
Observed Iodine Cmax111 ± 36
PrimaryObserved 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
Reported as:
Mean · ng/mL
Observed Iodine Baseline-Corrected Cmax
ng/mLAnti-caries Varnish
Observed Iodine Baseline-Corrected Cmax57 ± 33
PrimaryObserved 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
Reported as:
Mean · ng-h/mL
Observed Iodine Baseline-Corrected AUC
ng-h/mLAnti-caries Varnish
Observed Iodine Baseline-Corrected AUC539 ± 315
PrimaryObserved Iodine Total Urinary Recovery

Total urinary recovery in milligrams observed

Time frame:
baseline to 24 hours
Reported as:
Mean · mg
Observed Iodine Total Urinary Recovery
mgAnti-caries Varnish
Observed Iodine Total Urinary Recovery1.26 ± 0.71
PrimaryIodine 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
Reported as:
Mean · hours
Iodine t1/2
hoursAnti-caries Varnish
Iodine t1/25.5 ± 1.4
PrimaryObserved 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
Reported as:
Mean · hours
Observed Fluoride Tmax
hoursAnti-caries Varnish
Observed Fluoride Tmax0.8 ± 0.3
PrimaryObserved 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
Reported as:
Mean · ng/mL
Observed Fluoride Cmax
ng/mLAnti-caries Varnish
Observed Fluoride Cmax76 ± 36
PrimaryObserved Fluoride 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
Reported as:
Mean · ng/mL
Observed Fluoride Baseline-Corrected Cmax
ng/mLAnti-caries Varnish
Observed Fluoride Baseline-Corrected Cmax60 ± 34
PrimaryObserved 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
Reported as:
Mean · ng-h/mL
Observed Fluoride AUC
ng-h/mLAnti-caries Varnish
Observed Fluoride AUC703 ± 350
PrimaryObserved 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
Reported as:
Mean · ng-h/mL
Observed Fluoride Baseline-Corrected AUC
ng-h/mLAnti-caries Varnish
Observed Fluoride Baseline-Corrected AUC315 ± 206
PrimaryFluoride 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
Reported as:
Mean · hours
Fluoride t1/2
hoursAnti-caries Varnish
Fluoride t1/23.1 ± 1.6
PrimaryObserved Fluoride Total Urinary Recovery

Total urinary recovery in milligrams observed

Time frame:
baseline to 24 hours
Reported as:
Mean · mg
Observed Fluoride Total Urinary Recovery
mgAnti-caries Varnish
Observed Fluoride Total Urinary Recovery2.51 ± 1.28

Adverse events

Collected over 48 hours. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Anti-caries Varnish0/16 (0%)0/16 (0%)0/16 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Anti-caries Varnish
<=18 years0
Between 18 and 65 years16
>=65 years0
Age, Continuous
Age, Continuous(years)Anti-caries Varnish
Mean41.4 ± 13.4
Sex: Female, Male
Sex: Female, Male(Participants)Anti-caries Varnish
Female8
Male8
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Anti-caries Varnish
Hispanic or Latino0
Not Hispanic or Latino14
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Anti-caries Varnish
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American1
White11
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Anti-caries Varnish
United States16
08

Study locations

No study locations are listed for this record.

09

References and documents

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. PubMed 30938600 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 29, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04183231
Lead sponsor
Advantage Silver Dental Arrest, LLC
Collaborators
University of Washington
Responsible party
Sponsor
First posted
Dec 3, 2019
Start date
Nov 1, 2016
Primary completion
Feb 28, 2017
Completion
Apr 25, 2018
Results posted
Aug 21, 2020
Last update
Aug 21, 2020

Study contacts

Yvonne Lin, PhD
principal investigator · University of Washington School of Pharmacy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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