Efficacy and Safety Evaluation of Anti-Caries Varnish

NCT04947527 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019-10-19
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dental Caries in Children

Keywords

sodium fluoride; povidone iodine; dental varnish; primary dentition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse Events

  24 months post baseline

Study Arms (2)

Test Varnish

EXPERIMENTAL

Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.

Drug: Test varnish

Control Varnish

ACTIVE COMPARATOR

Control Varnish. 5% (w/v) Sodium Fluoride .

Drug: Placebo

Interventions

Test varnish DRUG

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.

Also known as: Advantage Anti-Caries Varnish

Test Varnish

Placebo DRUG

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.

Also known as: Placebo Varnish, Fluoride Varnish

Control Varnish

Eligibility Criteria

• Age: 10 Months - 20 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advantage Silver Dental Arrest, LLC: lead

Study Sites (1)

Pohnpei State Hospital

Pohnpei, FSM, 96941, United States Minor Outlying Islands

Location

Results Point of Contact

• Title: Dr. Peter Milgrom
• Organization: Advantage Silver Dental Arrest, LLC

drmilgrom@silverarrest.com

2062516831

Study Officials

• Ohnmar K Tut, BDS Phil

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study personnel except for designated personnel in the data center will be blinded to the participant treatment assignment. In order to maintain blinding and eliminate examiner bias, the staff member applying these varnishes will not perform the caries scoring exams.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single center randomized, double-blind, placebo-controlled, parallel-group trial.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: June 4, 2022
• Primary Completion: June 19, 2024
• Study Completion: August 5, 2024
• Last Updated: October 9, 2025
• Results First Posted: February 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

UN (1)