Povidone Iodine Efficacy Study

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.

NCT Number	NCT05272254
Lead Sponsor	University of Rochester
Conditions	Early Childhood Caries
Enrollment	202 participants
Start Date	2022-09-15
Primary Completion	2027-05 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-02-27