Actively Recruiting
Povidone Iodine Efficacy Study
Led by University of Rochester · Updated on 2026-02-27
202
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Povidone Iodine Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Children classified as American Society of Anesthesiologists (ASA) categories I and II
- Diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room (OR) based on American Academy of Pediatric Dentistry (AAPD) definition
You will not qualify if you...
- Known allergy or sensitivity to iodine, seafood, red or yellow food coloring, tea, or fluoride varnish
- Thyroid disease as determined by medical history
- Receiving or having received treatment with another investigational drug within 30 days of the baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14620
Actively Recruiting
Research Team
D
Dorota T Kopycka-Kedzierawski, DDS, MPH
CONTACT
K
Kathy Bohn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here