Recruiting
Phase 2

Povidone Iodine

Sponsor:

University of Rochester

Code:

NCT05272254

Conditions

Early Childhood Caries

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

Interventions

10% povidone iodine + FV

Placebo +FV

Study Details

Brief 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

Study ID

NCT05272254

Start date

Sep 15, 2022

Status verified date

Feb, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Provide signed and dated informed consent/permission form
  • Parents/primary caregivers willing to comply with all study procedures and be available for the duration of the study
  • Male or female, of any race, ethnicity, aged 24 to 71 months and their parents/primary caregivers who are 18 years of age or older or emancipated minors
  • In good general health as evidenced by medical history, per PI, and in compliance with current CDC, NYS Department of Health and URMC COVID-19 guidelines. American Society of Anesthesiologists (ASA) categories will be used; children classified as ASA I and ASA II will be eligible for the study.
  • Diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room (OR). A diagnosis of S-ECC will be based on the definition in accordance with American Academy of Pediatric Dentistry (AAPD)

Exclusion Criteria:

  • Having a known allergy or sensitivity to iodine or seafood, red or yellow food coloring, or to tea, including a hypersensitivity to fluoride varnish, or having thyroid disease, as determined by medical history
  • Receiving or having received treatment with another investigational drug within 30 days of the baseline visit (V1)

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Povidone Iodine

10% povidone iodine + fluoride varnish

placebo comparator: Placebo

Placebo (iced tea) + fluoride varnish

Interventions

10% povidone iodine + FV

applied to children's teeth

Placebo +FV

applied to children's teeth

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dorota T Kopycka-Kedzierawski, DDS, MPH

585-275-0706Dorota_KopyckaKedzierawski@urmc.rochester.edu

Kathy Bohn

585-273-5272Kathy_Bohn@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14620

Contacts

Kathy Bohn

585-273-5272Kathy_Bohn@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-02-27.