Efficacy and Safety Evaluation of Anti-Caries Varnish

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:

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 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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: Test varnish; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States Minor Outlying Islands
  • FSM
    • Pohnpei, FSM, United States Minor Outlying Islands, 96941
      • Pohnpei State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous treatment with fluoride varnish
2. Known allergy to iodine
3. Diagnosis of thyroid disease
4. Chronic, prophylactic use of antibiotics
5. Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit.
6. Visible cavities (d2-4)
7. 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)
8. Parent anticipates the child will move from Pohnpei during the next 2 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Varnish; Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.	Drug: 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.; Other Names: Advantage Anti-Caries Varnish
Active Comparator: Control Varnish; Control Varnish. 5% (w/v) Sodium Fluoride .	Drug: 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.; Other Names: Placebo Varnish; Fluoride Varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	12 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Cumulative Adverse and Serious Adverse Events	24 months post baseline

Collaborators and Investigators

• Sponsor: Advantage Silver Dental Arrest, LLC
• Investigators: Principal Investigator: Ohnmar K Tut, BDS Phil, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2022
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: sodium fluoride; povidone iodine; dental varnish; primary dentition
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: 2019-10-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No