Povidone Iodine Efficacy Study
ConditionEarly Childhood Caries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24-71
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 10% povidone iodine + FV
- Placebo +FV
Treatment groups
202 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov