Povidone Iodine Efficacy Study
University of Rochester
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 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.
Description
Objectives: Primary: To assess the efficacy of 10% PVPI in children with S-ECC to prevent new caries lesions after oral rehabilitation in the Operating Room (OR) under general anesthesia in children with S-ECC. The primary outcome variable is time from randomization to relapse. The development of an ICDAS caries code 1 or higher lesion post dental surgery is the sentinel event to calculate time to relapse. Secondary: 1. To determine incidence and severity of dental caries following oral rehabilitation in the OR. This outcome measure will be assessed by counting non-cavitated and cavit…
Eligibility
- Age range
- 2–5 years
- Sex
- All
- Healthy volunteers
- Yes
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 classifie…
Interventions
- Drug10% povidone iodine + FV
applied to children's teeth
- OtherPlacebo +FV
applied to children's teeth
Location
- University of RochesterRochester, New York