Povidone Iodine Efficacy Study

• Status: Not yet recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, randomized, double-blind, placebo-controlled Phase II clinical trial (RCT) to evaluate the efficacy of topical 10% Polyvinylpyrrolidone-Iodine (PVPI) to prevent new cavitated caries lesions when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). At baseline, following oral rehabilitation in the operating room {10% (PVPI + Fluoride Varnish (FV)} will be compared to the current standard of care (Placebo + FV). Study participants will be followed for approximately 24 months post-baseline. The study interventions post-baseline will be administered at 3, 6, 9, 12, 15, 18, and 21 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Treatments: Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• Provide signed and dated informed consent/permission form

• Parents/primary caregivers willing to comply with all study procedures and be available for the duration of the study

• Male or female, of any race, ethnicity, aged 24 to 71 months and their parents/primary caregivers who are 18 years of age or older or emancipated minors

• In good general health as evidenced by medical history, per PI, and in compliance with current CDC, NYS Department of Health and URMC COVID-19 guidelines. American Society of Anesthesiologists (ASA) categories will be used; children classified as ASA I and ASA II will be eligible for the study.

• Diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room (OR). A diagnosis of S-ECC will be based on the definition in accordance with American Academy of Pediatric Dentistry (AAPD)

Exclusion Criteria:

• Having a known allergy or sensitivity to iodine or seafood, red or yellow food coloring, or to tea, including a hypersensitivity to fluoride varnish, or having thyroid disease, as determined by medical history

• Receiving or having received treatment with another investigational drug within 30 days of the baseline visit (V1)