Efficacy and Safety Evaluation of Anti-Caries Varnish

NCT ID: NCT04947527

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-04
• Study Completion Date: 2024-08-05

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test Varnish

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

Group Type: EXPERIMENTAL

Test varnish

Intervention Type: 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.

Control Varnish

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

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Advantage Anti-Caries Varnish; Placebo Varnish; Fluoride Varnish

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 20 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Advantage Silver Dental Arrest, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ohnmar K Tut, BDS Phil

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Pohnpei State Hospital

Pohnpei, FSM, United States Minor Outlying Islands

Countries

United States Minor Outlying Islands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-10-19

Identifier Type: -

Identifier Source: org_study_id