Povidone Iodine Efficacy Study (PIES)

严重的儿童早期龋病(S)难以有效治疗，具有令人震惊和痛苦的特点 治疗后有复发的倾向。S龋病是一种特别急性的儿童早期龋病，即 以压倒性的促龋性微生物挑战为特征，包括变形链球菌(MS) 和乳杆菌(Lactobacilli(Lb))。卵巢癌/S-卵巢癌的护理标准围绕外科手术中的治疗展开 套房在全身麻醉下，然后应用5%的局部氟化物清漆，家庭咨询 关于喂养行为和口腔卫生的指导。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损。减少 局部应用抗菌药物的致龋性口腔微生物群是减少复发的潜在方法 青少年儿童S-ECC的发病情况。最近的研究表明，10%的聚维酮碘 (聚乙烯吡咯烷酮碘，10%PVPI)在预防幼儿龋齿方面似乎很有前途。一个元- 对抗菌素干预和与ECC相关的口腔微生物区系的分析突出了高... 关于包括PVPI在内的抗菌剂疗效的高质量随机对照试验。这些数据来自 国家健康和营养检查调查(NHANES 2011-2014)表明，ECC的患病率 美国学龄前儿童的比例为24%，范围在11%到72%之间。对临床、社会和公共卫生的影响 ECC/S-ECC的突出特点是它与乳牙期新龋损的风险增加有关， 恒牙期患龋率高、住院、急诊室就诊、高治疗率 教育成本的降低、上学天数的减少、学习能力的降低以及对儿童生活质量的深刻影响。初级阶段 目的：评价10%PVPI治疗儿童S-ECC的疗效。 部分或全部预防口腔后需要手术治疗的新的空洞性龋损 康复。具体目标是：1(UG3)：最后确定研究方案，制定程序手册 (MOP)，最后确定质量管理和数据管理计划，最后确定研究案例报告表(CRF)和 建立数据管理系统；2(UH3)：进行单中心随机、双盲、安慰剂试验- 评价外用10%PVPI预防新的空洞龋损的II期对照试验(RCT) 应用于口腔修复后S-ECC儿童的牙齿；3(UH3)：测量严重程度和 每季度接受口腔修复的S-ECC儿童的新龋病发生率 外用10%PVPI；4(UH3)：评估外用10%PVPI对口腔多样性和成分的影响 微生物区系，包括致龋性MS、Lb和假丝酵母菌，以更好地了解其作用机制 10%PVPI涂抹口腔微生物组。主要结果将是从随机化到空洞龋齿的时间。 病变(ICDAS代码3)是在术后首次发现的。龋齿增加量将与国际 龋齿检测和评估系统(ICDAS)。FDA批准的这项试验的IND是#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.