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Povidone Iodine Efficacy Study

Study acronym: PIES
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
    • Study description expanded, about 2 words
  2. Enrollment target: 246 to 202
    • Study description shortened, about 5 words
    v11
  3. 3 versions Re-verified since Sep 5, 2023, no change to tracked fieldsv8-v10
  4. Start date changed from estimate of Sep 2022 to Sep 15, 2022v7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. 2 versions Re-verified since Aug 10, 2022, no change to tracked fieldsv4-v5
  2. Start date: Jun 2022 to Sep 2022v3
  3. Interventions: 10% povidone iodine (Drug) to 10% povidone iodine + FV (Drug), Placebo +FV (Other)
    • Secondary endpoints: 3 to 4
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05272254
Lead Sponsor University of Rochester
Conditions
(from sponsor)		 Early Childhood Caries
Enrollment 202 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov