Evaluating the effectiveness of povidone iodine for preventing cavities in young children
Povidone Iodine Efficacy Study
This study is testing if a special iodine treatment can help prevent new cavities in young children who already have severe tooth decay.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 24 Months to 71 Months |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05272254 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, randomized, double-blind, placebo-controlled Phase II study aimed at assessing the efficacy of 10% Polyvinylpyrrolidone-Iodine (PVPI) in preventing new cavitated caries lesions in children diagnosed with Severe Early Childhood Caries (S-ECC). Participants will receive either the PVPI treatment combined with fluoride varnish or a placebo with fluoride varnish after undergoing oral rehabilitation in the operating room. The study will follow participants for approximately 24 months, monitoring the development of new carious lesions and the composition of oral microbiota. The primary outcome will be the time until relapse, defined as the occurrence of new cavitated lesions requiring further intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 24 to 71 months diagnosed with Severe Early Childhood Caries requiring treatment in the operating room.
Not a fit: Patients with known allergies to iodine or seafood, or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of new cavities in children with severe early childhood caries.
How similar studies have performed: While similar studies have explored the use of topical agents for caries prevention, the specific application of PVPI in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Dorota T Kopycka-Kedzierawski, DDS, MPH — University of Rochester
- Study coordinator: Dorota T Kopycka-Kedzierawski, DDS, MPH
- Email: Dorota_KopyckaKedzierawski@urmc.rochester.edu
- Phone: 585-275-0706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.