Actively Recruiting
Povidone Iodine Efficacy Study to Prevent New Caries Lesions in Children With Severe Early Childhood Caries
Led by University of Rochester · Updated on 2026-02-27
202
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a 10% Polyvinylpyrrolidone-Iodine (PVPI) topical treatment to prevent new dental caries lesions in children with Severe Early Childhood Caries (S-ECC). This randomized, double-blind, placebo-controlled Phase II clinical trial focuses on children aged 24 to 71 months who require oral rehabilitation under general anesthesia. The study will compare 10% PVPI combined with fluoride varnish (FV) to a placebo with FV over a two-year follow-up period to assess caries prevention after dental surgery. Participants will be randomly assigned to receive either the 10% PVPI solution plus fluoride varnish or a placebo solution plus fluoride varnish. The PVPI or placebo will be applied to the teeth with a microbrush after drying, followed by fluoride varnish application, which is the current standard of care. Treatment applications occur at baseline after oral rehabilitation and then at 3, 6, 9, 12, 15, 18, and 21 months post-baseline. During the study, children will be monitored through dental assessments for new caries lesions using the International Caries Diagnostic Assessment System (ICDAS) over the 24 months. Researchers will also analyze the diversity and composition of oral bacteria and fungi from saliva samples, track any adverse events reported by caregivers or observed by investigators, and measure the time to relapse with new caries lesions. The total participation duration is approximately 24 months with multiple follow-up visits.
CONDITIONS
Brief Title
Povidone Iodine Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent/permission form
- Parents or primary caregivers willing to comply with all study procedures and be available for the study duration
- Male or female, any race or ethnicity, aged 24 to 71 months with caregivers 18 years or older or emancipated minors
- In good general health as determined by medical history and compliance with current CDC, NYS Department of Health, and URMC COVID-19 guidelines
- Classified as American Society of Anesthesiologists (ASA) category I or II
- Diagnosed with Severe Early Childhood Caries requiring treatment in the operating room according to American Academy of Pediatric Dentistry (AAPD) criteria
You will not qualify if you...
- Known allergy or sensitivity to iodine, seafood, red or yellow food coloring, tea, fluoride varnish, or thyroid disease
- Received treatment with another investigational drug within 30 days before the baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive oral rehabilitation under general anesthesia followed by application of either 10% povidone iodine plus fluoride varnish or placebo plus fluoride varnish to their teeth.
Follow-up visits throughout the 24-month study period
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
K
Kathy Bohn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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