RECRUITING

Povidone Iodine Efficacy Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 cavitated 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.

Official Title

Povidone Iodine Efficacy Study

Quick Facts

Study Start:2022-09-15
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05272254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Months to 71 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Provide signed and dated informed consent/permission form
  2. * Parents/primary caregivers willing to comply with all study procedures and be available for the duration of the study
  3. * 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
  4. * 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.
  5. * 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)
  1. * 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
  2. * Receiving or having received treatment with another investigational drug within 30 days of the baseline visit (V1)

Contacts and Locations

Study Contact

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

Principal Investigator

Dorota T Kopycka-Kedzierawski, DDS, MPH
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

University of Rochester
Rochester, New York, 14620
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Dorota T Kopycka-Kedzierawski, DDS, MPH, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-15
Study Completion Date2027-05

Study Record Updates

Study Start Date2022-09-15
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Early Childhood Caries