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Efficacy and Safety Evaluation of Anti-Caries Varnish

Primary Purpose

Dental Caries in Children

Status

Active

Phase

Phase 2

Locations

United States Minor Outlying Islands

Study Type

Interventional

Intervention

Test varnish

Placebo

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring sodium fluoride, povidone iodine, dental varnish, primary dentition

Eligibility Criteria

10 Months - 20 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 10-20 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.

Exclusion Criteria:

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.

Sites / Locations

Pohnpei State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Varnish

Control Varnish

Arm Description

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

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

Outcomes

Primary Outcome Measures

Caries Increment

Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs)

Caries Incidence

Presence/Absence of dental caries lesions (d2-4mfs >0)

Secondary Outcome Measures

Adverse Events

Cumulative Adverse and Serious Adverse Events

Full Information

NCT ID

NCT04947527

First Posted

June 24, 2021

Last Updated

July 18, 2023

Sponsor

Advantage Silver Dental Arrest, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04947527

Brief Title

Efficacy and Safety Evaluation of Anti-Caries Varnish

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 4, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advantage Silver Dental Arrest, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 10-20 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries in Children

Keywords

sodium fluoride, povidone iodine, dental varnish, primary dentition

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

274 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Varnish

Arm Type

Experimental

Arm Description

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

Arm Title

Control Varnish

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Test varnish

Other Intervention Name(s)

Advantage Anti-Caries Varnish

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo Varnish, Fluoride Varnish

Intervention Description

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.

Primary Outcome Measure Information:

Title

Caries Increment

Description

Time Frame

24 months post baseline

Title

Caries Incidence

Description

Presence/Absence of dental caries lesions (d2-4mfs >0)

Time Frame

12 months post baseline

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Cumulative Adverse and Serious Adverse Events

Time Frame

24 months post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Months

Maximum Age & Unit of Time

20 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 10-20 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ohnmar K Tut, BDS Phil

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pohnpei State Hospital

City

Kolonia

State/Province

Pohnpei FSM

ZIP/Postal Code

96941

Country

United States Minor Outlying Islands

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety Evaluation of Anti-Caries Varnish

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