# Povidone Iodine Efficacy Study (PIES)

> **NIH NIH UH3** · UNIVERSITY OF ROCHESTER · 2022 · $1,065,714

## Abstract

Severe Early Childhood Caries (S-ECC) is difficult to treat effectively and has an alarming and distressing
tendency to recur following treatment. S-ECC is a particularly acute form of early childhood caries (ECC) that is
characterized by an overwhelming caries-promoting microbial challenge, including Mutans Streptococci (MS)
and Lactobacilli (LB). The standard of care for ECC/S-ECC revolves around treatment in a surgical operating
suite under general anesthesia, followed by application of 5% topical fluoride varnish, family counseling
regarding feeding behaviors and oral hygiene instruction. Clinical studies demonstrate approximately 40% of
children treated for S-ECC will develop new caries lesions within 12 months after dental surgery. Reducing
cariogenic oral microbiota with a topical anti-microbial agent is a potential approach to reduction of recurrent
disease in young children with S-ECC. Recent studies have shown that 10% povidone iodine
(polyvinylpyrrolidone-iodine, 10% PVPI) appears promising in preventing dental caries in young children. A meta-
analysis of antimicrobial interventions and the oral microbiota associated with ECC highlight the paucity of high-
quality randomized controlled trials on the efficacy of antimicrobial agents, including PVPI. The data from the
National Health and Nutritional Examination Survey (NHANES 2011-2014) indicates that the prevalence of ECC
in US preschool children is 24% and ranges between 11% and 72%. The clinical, social and public health impact
of ECC/S-ECC is underscored by its association with increased risk of new caries lesions in the primary dentition,
a higher risk of caries onset in the permanent dentition, hospitalizations, emergency room visits, high treatment
costs, lost school days, diminished ability to learn and a profound impact on a child’s quality of life. The primary
objective of this UG3/UH3 application is to assess the efficacy of 10% PVPI in children with S-ECC to
prevent, in part or in whole, new cavitated caries lesions that require surgical intervention after oral
rehabilitation. The Specific Aims are: 1 (UG3): to finalize the study protocol, develop the Manual of Procedures
(MOP), finalize quality management and data management plans, finalize study case report forms (CRFs) and
set-up data management system; 2 (UH3): to conduct a single center randomized, double-blind, placebo-
controlled Phase II trial (RCT) to evaluate the efficacy of topical 10% PVPI to prevent new cavitated caries lesions
when applied to the teeth of children with S-ECC following oral rehabilitation; 3 (UH3): to measure severity and
incidence of new dental caries in children with S-ECC following oral rehabilitation who are receiving quarterly
topical 10% PVPI; 4 (UH3): to assess the effect of topical 10% PVPI on diversity and composition of oral
microbiota, including cariogenic MS, LB and Candida species to better understand the mechanism of action of
10% PVPI on the oral microbiome. The primary outcome wi...

## Key facts

- **NIH application ID:** 10610146
- **Project number:** 4UH3DE030434-02
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Dorota T. Kopycka-Kedzierawski
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,065,714
- **Award type:** 4N
- **Project period:** 2022-05-01 → 2027-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10610146

## Citation

> US National Institutes of Health, RePORTER application 10610146, Povidone Iodine Efficacy Study (PIES) (4UH3DE030434-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10610146. Licensed CC0.

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