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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
Approved for 5 Other Conditions
All Individual Drugs Already Approved

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
872 Previous Clinical Trials
549,851 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
~125 spots leftby May 2027
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