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 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.