| NCT ID | NCT05272254 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Rochester |
| Condition | Early Childhood Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 202 participants in total. It began in 2022-09-15 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Dorota T Kopycka-Kedzierawski, DDS, MPH
✉ Dorota_KopyckaKedzierawski@urmc.rochester.edu📞 585-275-0706
Dorota T Kopycka-Kedzierawski, DDS, MPH
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT05272254 clinical trial?
This trial is open to participants of all sexes, aged 24 Months or older, up to 71 Months, studying Early Childhood Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05272254 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05272254 currently recruiting?
Yes, NCT05272254 is actively recruiting participants. Contact the research team at Dorota_KopyckaKedzierawski@urmc.rochester.edu for enrollment information.
Where is the NCT05272254 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05272254 clinical trial?
NCT05272254 is sponsored by University of Rochester. The principal investigator is Dorota T Kopycka-Kedzierawski, DDS, MPH at University of Rochester. The trial plans to enroll 202 participants.