Povidone Iodine Efficacy Study

NCT05272254 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY0000706421-057-E
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Caries lesion

  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.

  Randomization to relapse, up to 24 months

Secondary Outcomes (4)

• Incidence and severity of dental caries

  Randomization to relapse, up to 24 months

• Diversity of oral microbiota

  Randomization to relapse, up to 24 months

• Adverse Event Occurrence

  Enrollment to 24 months

• Composition of Microbiota

  Randomization to relapse, up to 24 months

Study Arms (2)

Povidone Iodine

EXPERIMENTAL

10% povidone iodine + fluoride varnish

Drug: 10% povidone iodine + FV

Placebo

PLACEBO COMPARATOR

Placebo (iced tea) + fluoride varnish

Other: Placebo +FV

Interventions

10% povidone iodine + FV DRUG

applied to children's teeth

Also known as: betadine

Povidone Iodine

Placebo +FV OTHER

applied to children's teeth

Also known as: Iced tea

Placebo

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14620, United States

RECRUITING

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Dorota T Kopycka-Kedzierawski, DDS, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorota T Kopycka-Kedzierawski, DDS, MPH

CONTACT

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

Kathy Bohn

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: September 15, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)