Efficacy and Safety Evaluation of Anti-Caries Varnish

Sponsor

Advantage Silver Dental Arrest, LLC (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04947527

Collaborator

(none)

274

Enrollment

Location

Arms

29.9

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Drug: Test varnish Drug: Placebo	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

274 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 4, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Caries Increment [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) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs)
Caries Incidence [12 months post baseline]
Presence/Absence of dental caries lesions (d2-4mfs >0)

Secondary Outcome Measures

Adverse Events [24 months post baseline]
Cumulative Adverse and Serious Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Months to 20 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.