Povidone Iodine Efficacy Study

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05272254
Phase
PHASE2
Status
Recruiting
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Conditions

  • Early Childhood Caries

Eligibility Criteria

Sex
ALL
Age
24 Months - 71 Months
Healthy Volunteers
Accepted

Interventions

  • 10% povidone iodine + FV — DRUG
    applied to children's teeth
  • Placebo +FV — OTHER
    applied to children's teeth

Study Details

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.

Key Dates

Start date
Sep 15, 2022
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
202 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Povidone Iodine
    10% povidone iodine + fluoride varnish
  • Placebo Comparator: Placebo
    Placebo (iced tea) + fluoride varnish

Primary Outcome Measure

Caries lesion [ Time Frame: Randomization to relapse, up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14620
Kathy Bohn
[email protected]
585-273-5272

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