Povidone Iodine Study for Childhood Cavities

Is Povidone Iodine, which kills bacteria, effective at preventing new cavities in children who have Severe Early Childhood Caries (S-ECC)?

Lead Researcher: Dorota Kopycka-kedzierawski

This is a clinical trial to determine whether 10% Povidone Iodine prevents new cavities when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). Study participants will be followed for approximately 24 months after receiving treatment. Children age 24 to 71 months with parents/guardians who are 18 or older are eligible. Children must be diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room.

More Details:

• https://clinicaltrials.gov/ct2/show/NCT05272254
• Video explaining study

Eligibility:

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)