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Povidone Iodine Efficacy Study

NCT05272254 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2026-02-27

No results posted yet for this study

Summary

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.

Conditions

  • Early Childhood Caries

Interventions

DRUG

10% povidone iodine + FV

applied to children's teeth

OTHER

Placebo +FV

applied to children's teeth

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Dorota T Kopycka-Kedzierawski, DDS, MPH · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05272254 on ClinicalTrials.gov