Trial Outcomes & Findings for Safety Evaluation of Advantage Anti-Caries Varnish (NCT NCT02645617)

NCT ID: NCT02645617

Last Updated: 2020-01-21

Results Overview

Proportion of participants with any oral ulcerations OR inflammatory response

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: within 48 hours
• Results posted on: 2020-01-21

Participant Flow

Participant milestones

Measure	Varnish Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Evaluation of Advantage Anti-Caries Varnish

Baseline characteristics by cohort

Measure	Varnish n=12 Participants Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: within 48 hours

Proportion of participants with any oral ulcerations OR inflammatory response

Outcome measures

Measure	Varnish n=12 Participants Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Soft Tissue	0 Participants

SECONDARY outcome

Timeframe: within 48 hours

Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea

Outcome measures

Measure	Varnish n=12 Participants Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Adverse Events	0 Participants

Adverse Events

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

Peter Milgrom

Advantage Silver Dental Arrest, LLC

Phone: 2062516831

Email: drmilgrom@silverarrest.com

Results disclosure agreements

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