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

2019-10-19

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.

2022-06-04

2024-06-01

2024-12-01

Active (not recruiting)

Early phase I

274

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single center randomized, double-blind, placebo-controlled, parallel-group trial.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 274, 'type': 'ACTUAL'}}

2023-07-20