Efficacy and Safety Evaluation of Anti-Caries Varnish

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04947527
• Other study ID #: 2019-10-19
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 4, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Advantage Silver Dental Arrest, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 20 Months

Eligibility

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 10-20 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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States Minor Outlying Islands	Pohnpei State Hospital	Kolonia	Pohnpei FSM

Sponsors (1)

Lead Sponsor	Collaborator
Advantage Silver Dental Arrest, LLC

Country where clinical trial is conducted

United States Minor Outlying Islands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months post baseline
Primary	Caries Incidence	Presence/Absence of dental caries lesions (d2-4mfs >0)	12 months post baseline
Secondary	Adverse Events	Cumulative Adverse and Serious Adverse Events	24 months post baseline