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Antiseptic

Povidone Iodine + Fluoride Varnish for Early Childhood Caries (PIES Trial)

Phase 2
Recruiting
Led By Dorota T Kopycka-Kedzierawski, DDS, MPH
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to 24 months
Awards & highlights

PIES Trial Summary

This trial will compare the efficacy of 10% Polyvinylpyrrolidone-Iodine (PVPI) to prevent new cavitated caries lesions in children with Severe Early Childhood Caries (S-ECC), compared to the current standard of care (Placebo + Fluoride Varnish (FV)).

Who is the study for?
This trial is for children aged 24 to 71 months with severe early childhood caries needing treatment in the operating room. It's open to kids in good health and ASA I or II categories. Parents must consent, follow study procedures, and adhere to COVID-19 guidelines. Kids with iodine or seafood allergies, sensitivity to certain food colorings or tea, recent investigational drug use, or thyroid disease can't participate.Check my eligibility
What is being tested?
The trial tests if applying a topical solution of 10% povidone iodine plus fluoride varnish (PVPI + FV) prevents new cavities better than placebo plus fluoride varnish (Placebo + FV). Children will be randomly assigned treatments and followed for about two years with applications at several intervals post-baseline.See study design
What are the potential side effects?
Possible side effects may include allergic reactions related to iodine sensitivity such as skin rash or more serious symptoms if there's a known allergy. Since it's applied topically on teeth, systemic side effects are less likely but could occur depending on individual sensitivities.

PIES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has severe early tooth decay needing treatment in an OR, as defined by the AAPD.
Select...
I am between 2 and almost 6 years old, or I am the adult caregiver of someone in that age range.

PIES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caries lesion
Secondary outcome measures
Adverse Event Occurrence
Composition of Microbiota
Diversity of oral microbiota
+1 more

PIES Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Povidone IodineExperimental Treatment1 Intervention
10% povidone iodine + fluoride varnish
Group II: PlaceboPlacebo Group1 Intervention
Placebo (iced tea) + fluoride varnish

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
840 Previous Clinical Trials
534,004 Total Patients Enrolled
1 Trials studying Early Childhood Caries
380 Patients Enrolled for Early Childhood Caries
Dorota T Kopycka-Kedzierawski, DDS, MPHPrincipal InvestigatorUniversity of Rochester

Media Library

10% Povidone Iodine (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT05272254 — Phase 2
Early Childhood Caries Research Study Groups: Povidone Iodine, Placebo
Early Childhood Caries Clinical Trial 2023: 10% Povidone Iodine Highlights & Side Effects. Trial Name: NCT05272254 — Phase 2
10% Povidone Iodine (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05272254 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this clinical investigation?

"Confirmed. Clinicaltrials.gov displays current information about this medical experiment, which was initially posted on September 15th 2022 and recently updated on the 19th of that same month. A total of 246 patients must be enrolled from a single site for the trial to proceed."

Answered by AI

For whom is participation in this research project open?

"The medical trial is looking for 246 children aged between 2 and 6 years old that suffer from Severe-Early Childhood Caries (S-ECC). Eligibility criteria also extends to parent/primary caregivers who are 18 or older and in good health, with both parties agreeing to comply with study protocols. Additionally, participants must be ASA I or II according the American Society of Anesthesiologists classification system as well as adhere to all CDC, NYS Department of Health and URMC COVID-19 guidelines."

Answered by AI

Are there still available positions in this scientific investigation?

"Affirmative. Clinicaltrials.gov reflects that this medical trial, which was initially advertised on September 15th 2022, is currently enrolling patients. A total of 246 individuals will be accepted from a single test centre."

Answered by AI

Has the amalgamation of 10% povidone iodine and FV been granted sanction by the FDA?

"Our team at Power assessed 10% povidone iodine + FV to be a 2 on the safety scale due to existing data indicating protection from harm, but no evidence of efficacy."

Answered by AI

Does this experiment accept individuals aged 25 and above as participants?

"This clinical trial is accepting patients aged between 24 and 71 months old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Povidone Iodine Efficacy Study
Dorota Kopycka-Kedzierawski 2022. "Povidone Iodine Efficacy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05272254.
~161 spots leftby May 2027
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