Povidone Iodine Efficacy Study

Launched by UNIVERSITY OF ROCHESTER · Feb 28, 2022

Keywords

ClinConnect Summary

The Povidone Iodine Efficacy Study is a clinical trial looking at whether a topical treatment called 10% Polyvinylpyrrolidone-Iodine (PVPI) can help prevent new cavities in young children who have Severe Early Childhood Caries (S-ECC). Children in the trial will receive either the PVPI treatment along with fluoride varnish or a placebo (a treatment that looks the same but has no active ingredient) with fluoride varnish. The study aims to see how effective the PVPI is over a period of about 24 months, with follow-up visits scheduled every few months.

To participate, children must be between 24 to 71 months old (about 2 to 6 years) and have S-ECC that requires treatment in the operating room. Parents or caregivers need to be willing to follow the study procedures and be available for the entire duration. It's important that children do not have allergies to iodine or seafood, and they should not have received any other investigational treatments recently. If you're interested in this study, it could provide valuable insights into new ways to protect children's dental health.

Gender

ALL

Eligibility 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)