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Povidone Iodine Efficacy Study (PIES)

聚维酮碘功效研究 (PIES)

基本信息

批准号：
10610146
负责人：
Dorota T. Kopycka-Kedzierawski
金额：
$ 106.57万
依托单位：
UNIVERSITY OF ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-05-01 至 2027-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10610146
关键词：
Acute Address Candida Caregivers Case Report Form Case Study Child Clinical Clinical Research Code Communicable Diseases Counseling Data Data Management Resources Dental Enamel Dental Hygiene Dental caries Detection Disease Distress Double-Blind Method Emergency department visit FDA approved Family Feeding behaviors Fluoride Varnishes General Anesthesia Health Heterogeneity Hospitalization Incidence Instruction International Intervention Lactobacillus Learning Lesion Manuals Measures Meta-Analysis Mouth Diseases Nutritional Operative Surgical Procedures Oral Outcome Placebo Control Placebos Povidone-Iodine Preschool Child Prevalence Prevention Preventive Primary Dentition Procedures Protocols documentation Public Health Quality of life Randomized Randomized Controlled Trials Recurrent disease Rehabilitation therapy Reporting Risk Schools Severities Streptococcus mutans Surveys System Time Tooth structure Topical Antibiotic Topical Fluorides Treatment Cost antimicrobial antimicrobial drug base data management dental surgery early childhood early onset efficacy evaluation efficacy study high risk improved lower income families microbial novel oral microbial community oral microbiome permanent tooth phase II trial prevent primary outcome social standard of care success topical antibacterial

项目摘要

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 will be time from randomization until cavitated carious lesion (ICDAS code 3) is first detected post-surgery. Caries increment will be measured with the International Caries Detection and Assessment System (ICDAS). The approved FDA IND for this trial is #108961.

严重幼儿龋病是一种难以有效治疗的疾病，令人担忧和苦恼