Condition: Early Childhood Caries · Sponsor: University of Rochester
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.
This description comes directly from the study's public registry record.
Dorota T Kopycka-Kedzierawski, DDS, MPH · 585-275-0706 · Dorota_KopyckaKedzierawski@urmc.rochester.edu
Kathy Bohn · 585-273-5272 · Kathy_Bohn@urmc.rochester.edu
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| University of Rochester | Rochester, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05272254