Trial Outcomes & Findings for Efficacy and Safety Evaluation of Anti-Caries Varnish (NCT NCT04947527)

Last Updated: 2025-10-09

Results Overview

Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline, which is the number of surfaces at 24 months post baseline with cavitation into the enamel (d2), dentin (d3) or pulp (d4), missing due to caries (m) or filled (f).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

274 participants

Primary outcome timeframe

24 months post baseline

Results posted on

2025-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Test Varnish Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. Test varnish: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.	Control Varnish Control Varnish. 5% (w/v) Sodium Fluoride . Placebo: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Overall Study STARTED	132	142
Overall Study COMPLETED	121	123
Overall Study NOT COMPLETED	11	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Evaluation of Anti-Caries Varnish

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Varnish n=132 Participants Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. Test varnish: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.	Control Varnish n=142 Participants Control Varnish. 5% (w/v) Sodium Fluoride . Placebo: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.	Total n=274 Participants Total of all reporting groups
Age, Continuous	13.9 Months STANDARD_DEVIATION 4.4 • n=93 Participants	14.3 Months STANDARD_DEVIATION 4.5 • n=4 Participants	14.1 Months STANDARD_DEVIATION 4.4 • n=27 Participants
Sex: Female, Male Female	66 Participants n=93 Participants	83 Participants n=4 Participants	149 Participants n=27 Participants
Sex: Female, Male Male	66 Participants n=93 Participants	59 Participants n=4 Participants	125 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	132 Participants n=93 Participants	142 Participants n=4 Participants	274 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 months post baseline

Population: All children with follow-up at 24 months post-baseline.

Outcome measures

Outcome measures
Measure	Test Varnish n=121 Participants Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. Test varnish: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.	Control Varnish n=123 Participants Control Varnish. 5% (w/v) Sodium Fluoride . Placebo: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Caries Increment	9.8 Number of tooth surfaces Standard Deviation 10.6	11.3 Number of tooth surfaces Standard Deviation 10.8

PRIMARY outcome

Timeframe: 12 months post baseline

Population: All children with follow-up 12 months post-baseline.

Presence/Absence of dental caries lesions (d2-4mfs \>0), which is defined by the presence at 12 months post baseline of 1 or more tooth surfaces with cavitation into the enamel (d2), into the dentin (d3), or into the pulp (d4), missing due to caries (m) or filled (f).

Outcome measures

Outcome measures
Measure	Test Varnish n=124 Participants Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. Test varnish: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.	Control Varnish n=126 Participants Control Varnish. 5% (w/v) Sodium Fluoride . Placebo: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces	53 Participants	72 Participants

SECONDARY outcome

Timeframe: 24 months post baseline

Cumulative Adverse and Serious Adverse Events

Outcome measures

Outcome measures
Measure	Test Varnish n=132 Participants Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. Test varnish: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.	Control Varnish n=142 Participants Control Varnish. 5% (w/v) Sodium Fluoride . Placebo: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Adverse Events	42 Participants	58 Participants

Adverse Events

Test Varnish

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Control Varnish

Serious events: 0 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Peter Milgrom

Advantage Silver Dental Arrest, LLC

Phone: 2062516831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Test Varnish n=132 participants at risk Anti-Caries Varnish: The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.	Control Varnish n=142 participants at risk Control Varnish: 5% (w/v) Sodium Fluoride.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/132 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Metabolism and nutrition disorders Blood deficiency	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.00% 0/142 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
General disorders Candidiasis	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	1.4% 2/142 • Number of events 2 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Respiratory, thoracic and mediastinal disorders Cough	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	3.5% 5/142 • Number of events 5 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Infections and infestations COVID-19	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	1.4% 2/142 • Number of events 2 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Metabolism and nutrition disorders Dehydration	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.00% 0/142 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Gastrointestinal disorders Diarrhea	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
General disorders Fever	5.3% 7/132 • Number of events 7 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	7.7% 11/142 • Number of events 11 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Infections and infestations Flu	23.5% 31/132 • Number of events 36 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	31.0% 44/142 • Number of events 47 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Infections and infestations Pink eye	0.00% 0/132 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Respiratory, thoracic and mediastinal disorders Runny nose	0.00% 0/132 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Immune system disorders Skin rash	0.00% 0/132 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Immune system disorders Small vesicles	0.00% 0/132 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Gastrointestinal disorders Toothache	0.76% 1/132 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.00% 0/142 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.
Gastrointestinal disorders Vomiting	0.00% 0/132 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.	0.70% 1/142 • Number of events 1 • Two years from baseline through 24-month follow-up. Primary collection approach was non-systematic by parent self-report, and secondary collection approach was systematic by dental exam at 12-month and 24-month follow-ups.