Trial Outcomes & Findings for Pharmacokinetics of Advantage Anti-Caries Varnish (NCT NCT04183231)

NCT ID: NCT04183231

Last Updated: 2020-08-21

Results Overview

Time to maximum serum concentration of iodine in hours

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
• Results posted on: 2020-08-21

Participant Flow

Participant milestones

Measure	Anti-caries Varnish topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Advantage Anti-Caries Varnish

Baseline characteristics by cohort

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.4 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Time to maximum serum concentration of iodine in hours

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Iodine Tmax	1.7 hours Standard Deviation 0.7

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Maximum serum concentration of iodine in ng/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Iodine Cmax	111 ng/mL Standard Deviation 36

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Maximum serum concentration of iodine in ng/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Iodine Baseline-Corrected Cmax	57 ng/mL Standard Deviation 33

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Area under the Curve for observed iodine in ng*h/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Iodine Baseline-Corrected AUC	539 ng-h/mL Standard Deviation 315

PRIMARY outcome

Timeframe: baseline to 24 hours

Total urinary recovery in milligrams observed

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Iodine Total Urinary Recovery	1.26 mg Standard Deviation 0.71

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Terminal elimination half-life of iodine in hours

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Iodine t1/2	5.5 hours Standard Deviation 1.4

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Time to maximum serum concentration in hours

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Fluoride Tmax	0.8 hours Standard Deviation 0.3

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Maximum serum concentration of fluoride in ng/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Fluoride Cmax	76 ng/mL Standard Deviation 36

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Maximum serum concentration of iodine in ng/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Fluoride Baseline-Corrected Cmax	60 ng/mL Standard Deviation 34

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Area under the Curve for observed fluoride in ng*h/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Fluoride AUC	703 ng-h/mL Standard Deviation 350

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Area under the Curve for observed fluoride in ng*h/mL

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Fluoride Baseline-Corrected AUC	315 ng-h/mL Standard Deviation 206

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

Terminal elimination half-life in hours for fluoride

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Fluoride t1/2	3.1 hours Standard Deviation 1.6

PRIMARY outcome

Timeframe: baseline to 24 hours

Total urinary recovery in milligrams observed

Outcome measures

Measure	Anti-caries Varnish n=16 Participants topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish
Observed Fluoride Total Urinary Recovery	2.51 mg Standard Deviation 1.28

Adverse Events

Anti-caries Varnish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Milgrom

Advantage Silver Dental Arrest, LLC

Phone: 206-2516831

Email: drmilgrom@silverarrest.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place