Povidone Iodine Efficacy Study (PIES)

严重的儿童早期龋齿（S-ECC）难以有效治疗，并且具有令人担忧和令人痛心的 治疗后复发的趋势。S-ECC是一种特别急性的儿童早期龋齿（ECC）， 以压倒性的促龋微生物挑战为特征，包括变形链球菌（MS） 和乳酸杆菌（LB）。ECC/S-ECC的护理标准围绕外科手术治疗 在全身麻醉下，然后应用5%的局部氟化物保护漆，家庭咨询 关于喂养行为和口腔卫生指导。临床研究表明，大约40%的 接受S-ECC治疗的儿童在牙科手术后12个月内会出现新的龋齿病变。减少 局部使用抗微生物剂的致龋口腔微生物群是减少复发性 疾病与S-ECC的幼儿。最近的研究表明，10%聚维酮碘 （聚乙烯吡咯烷酮碘，10%PVPI）在预防幼儿龋齿方面似乎是有希望的。一个Meta- 对抗菌干预措施和与ECC相关的口腔微生物群的分析强调， 关于抗菌药物（包括PVPI）有效性的高质量随机对照试验。的数据 国家健康和营养检查调查（NHANES 2011-2014）表明，ECC的患病率 在美国学龄前儿童中为24%，范围在11%和72%之间。临床、社会和公共卫生影响 ECC/S-ECC与乳牙列中新龋齿病变风险增加的相关性强调了这一点， 恒牙期龋齿发病的风险较高，住院，急诊室就诊，高治疗 这不仅会增加成本，减少上学时间，降低学习能力，而且会对儿童的生活质量产生深远影响。主 本UG 3/UH 3申请的目的是评估10% PVPI在S-ECC儿童中的疗效， 部分或全部预防在口服后需要手术干预的新的空洞化龋齿病变， 康复活动.具体目标为：1（UG 3）：最终确定研究方案，制定程序手册 (MOP)，最终确定质量管理和数据管理计划，最终确定研究病例报告表（CRF）， 建立数据管理系统; 2（UH 3）：进行单中心随机、双盲、安慰剂- 评价局部10% PVPI预防新的空洞龋病变的有效性的对照II期试验（RCT） 当应用于口腔康复后患有S-ECC的儿童的牙齿时; 3（UH 3）：测量严重程度和 每季度接受一次口腔康复治疗的S-ECC儿童的新龋齿发病率 局部10%PVPI; 4（UH 3）：评估局部10%PVPI对口腔黏膜多样性和组成的影响 微生物群，包括致龋MS，LB和念珠菌属物种，以更好地了解 10%PVPI对口腔微生物组的影响。主要结局将是从随机分组到出现龋洞的时间 术后首先检测到病变（ICDAS代码3）。龋齿增量将用国际 龋齿检测和评估系统（ICDAS）。本试验获批的FDA IND为#108961。

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.