Status:
RECRUITING
Povidone Iodine Efficacy Study
Lead Sponsor:
University of Rochester
Conditions:
Early Childhood Caries
Eligibility:
All Genders
24-71 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Objectives: Primary: To assess the efficacy of 10% PVPI in children with S-ECC to prevent new cavitated caries lesions that require follow-up restorative/surgical intervention after oral rehabilitat...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT05272254
Start Date
September 15 2022
End Date
May 1 2027
Last Update
December 15 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14620