Dental Caries in ChildrenPhase 2NCT04947527

Efficacy and Safety Evaluation of Anti-Caries Varnish

A Phase 2 study testing Test varnish in people with Dental Caries in Children, run by Advantage Silver Dental Arrest, LLC at 1 site in United States Minor Outlying Islands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine the efficacy \& safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are: 1) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries… Read more about this study

Who is it for?: Ages 10 to 20 monthsHealthy volunteers can take part
Conditions the study is for: Dental Caries in Children
What is being tested?: Test varnish
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 274 participants
Where: 1 siteUnited States Minor Outlying Islands
Study dates: 4 Jun 2022to 5 Aug 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 20 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
The subject is a 6-24 months at the time of enrollment.
The subject must be in good general health as evidenced by parent report.
The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion.

Who cannot join

Previous treatment with fluoride varnish
Known allergy to iodine
Diagnosis of thyroid disease
Chronic, prophylactic use of antibiotics
Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit.
Visible cavities (d2-4)
Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared)
Parent anticipates the child will move from Pohnpei during the next 2 years.

Trial locations and contacts

1 site in 1 country.

United States Minor Outlying Islands1 site

Pohnpei State Hospital
Pohnpei, FSM, 96941

About this study

Official title: Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention

The purpose of the study is to determine the efficacy \& safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are:

To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.

Read the detailed description

This is a single center randomized, double-blind, placebo-controlled, parallel-group trial. The treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. The control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. Half will be randomized to each arm. Subjects will be 6-24 mo of age and in good health. Children attending Maternal and Child Health (MCH) Immunization and Well Child programs in Pohnpei State will be enrolled. Primary Outcome Variables: 1) Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) Presence/Absence of dental caries lesions (d2-4mfs >0) at 12 months post baseline. Secondary Outcome Variable: Adverse Events

Conditions: Dental Caries in Children
Being tested: Test varnish, Placebo
Keywords: sodium fluoride, povidone iodine, dental varnish, primary dentition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test varnishDrug
Also called Advantage Anti-Caries 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.
PlaceboDrug
Also called Placebo Varnish, Fluoride 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.

Study groups in NCT04947527
Study group	Role	What they receive
Test Varnish	Experimental	Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. Receives: Drug: Test varnish
Control Varnish	Active comparator	Control Varnish. 5% (w/v) Sodium Fluoride . Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Caries Increment
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).
Measured: 24 months post baseline
Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces
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).
Measured: 12 months post baseline

Secondary outcomes (1)

Adverse Events
Cumulative Adverse and Serious Adverse Events
Measured: 24 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 20225 Aug 2024

First posted1 Jul 2021
Study start4 Jun 2022
Primary completion19 Jun 2024
Study completion5 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a single center randomized, double-blind, placebo-controlled, parallel-group trial.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04947527
Sponsor's protocol ID: 2019-10-19
Status last verified: Aug 2024
First submitted: 24 Jun 2021
Last updated: 9 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dental Caries in Children trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention
ClinicalTrials.gov ID: NCT04947527
Acronym / sponsor ID: 2019-10-19
Conditions: Dental Caries in Children
Keywords: sodium fluoride, povidone iodine, dental varnish, primary dentition
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Advantage Silver Dental Arrest, LLCIndustry (pharma, biotech, devices)
Study start: 4 Jun 2022 (actual)
Primary completion: 19 Jun 2024 (actual)
Study completion: 5 Aug 2024 (actual)
First posted: 1 Jul 2021 (actual)
Results: Posted 3 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to determine the efficacy \& safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are:

To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This is a single center randomized, double-blind, placebo-controlled, parallel-group trial.

Arm	Type	Receives
Test Varnish	Experimental	Drug: Test varnishAnti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.
Control Varnish	Active comparator	Drug: PlaceboControl Varnish. 5% (w/v) Sodium Fluoride .

Who may qualify

Ages: 10 to 20 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
The subject is a 6-24 months at the time of enrollment.
The subject must be in good general health as evidenced by parent report.
The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion.

Key exclusion criteria (8 listed)

Previous treatment with fluoride varnish
Known allergy to iodine
Diagnosis of thyroid disease
Chronic, prophylactic use of antibiotics
Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Test varnishAlso: Advantage Anti-Caries VarnishA 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.	Drug	Test Varnish
PlaceboAlso: Placebo Varnish, Fluoride VarnishA 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.	Drug	Control Varnish

Primary outcome

Caries Increment
Time frame: 24 months post baseline
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).
Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces
Time frame: 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).

1 secondary outcome

Adverse Events
Time frame: 24 months post baseline

Results and safety

Results posted to the registry on 3 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Varnish	132	121
Control Varnish	142	123

Primary outcome: Caries Increment

Time frame: 24 months post baseline. Mean (Standard Deviation). Unit: Number of tooth surfaces

Measure	Test Varnish n = 121	Control Varnish n = 123
Value	9.8 (10.6)	11.3 (10.8)

Test Varnish vs Control Varnish: Mean Difference (Final Values): -1.5 (95% CI -4.2 to 1.2), p = 0.279, t-test, 2 sided

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

Primary outcome: Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces

Time frame: 12 months post baseline. Count of participants. Unit: Participants

Measure	Test Varnish n = 124	Control Varnish n = 126
Value	53	72

Test Varnish vs Control Varnish: Difference in percentages/proportions: -14.4 (95% CI -26.7 to -2.1), p = 0.023, Chi-squared

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Two years from baseline through 24-month follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Varnish	0 of 132 (0%)	42 of 132 (31.8%)	0 of 132
Control Varnish	0 of 142 (0%)	58 of 142 (40.8%)	0 of 142

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ohnmar K Tut, BDS Phil principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Test varnish in people with Dental Caries in Children, run by Advantage Silver Dental Arrest, LLC at 1 site in United States Minor Outlying Islands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States Minor Outlying Islands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caries Increment (time frame: 24 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04947527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.