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NCT05272254 · ClinicalTrials.gov registry record · Phase 2
Povidone Iodine Efficacy Study
A Phase 2 study of Early Childhood Caries, sponsored by University of Rochester.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
- 1
- Study location
NCT05272254: Recruiting Phase 2 study of Early Childhood Caries, sponsored by University of Rochester.
NCT05272254 is a Phase 2 study of Early Childhood Caries that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 202 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05272254, a Phase 2 study of Early Childhood Caries, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome variable is time from randomization to relapse. The development of an ICDAS caries code 1 or higher lesion post dental surgery is the sentinel event to calculate time to relapse.
Conditions Studied
Interventions
- DRUG 10% povidone iodine + FV
- OTHER Placebo +FV
Study Locations (1)
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What NCT05272254 shows while recruiting
NCT05272254 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher).
The record links to 1 condition, with Early Childhood Caries appearing as the primary indexed condition, and to 2 interventions - of which 10% povidone iodine + FV is the first listed.
NCT05272254 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05272254 about?
NCT05272254 is a clinical study titled "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, ...
What is the current status of trial NCT05272254?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2022-09-15. Estimated completion is 2027-05.
What conditions does trial NCT05272254 study?
This clinical trial studies the following conditions: Early Childhood Caries.
What interventions are being tested in trial NCT05272254?
The interventions under investigation include: 10% povidone iodine + FV (DRUG), Placebo +FV (OTHER).
Who is sponsoring clinical trial NCT05272254?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05272254 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05272254's enrollment target sits among peer trials
202 301st of 2000 higher than 1,700 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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