Improving Clinical Outcomes for Early Chilhood Caries

描述(由申请人提供)：幼儿龋病(ECC)仍然是一个影响全球婴儿和学龄前儿童的公共卫生问题。目前的临床护理标准忽视了ECC是一种传染病的概念，其特征是压倒性的变形链球菌(MS)感染和腐烂促进摄食行为。治疗通常仅限于拔除和修复龋齿，并就促进龋齿的喂养行为进行咨询。牙科手术对口腔多发性硬化症宿主的影响微乎其微，有关饮食习惯的咨询也收效甚微。毫不奇怪，在全身麻醉下接受ECC治疗的儿童中，大约40%的儿童在治疗后6-12个月内复发并出现新的龋损。改善ECC治疗的临床结果很可能通过重点关注这种疾病的感染方面的治疗策略来实现。用抗菌剂抑制口腔多发性硬化症储存库是一种有前途的方法。在这方面，10%聚维酮碘被批准为儿童手术前皮肤和粘膜消毒剂，初步数据表明，它 即使在ECC环境下，对口腔多发性硬化症人群也有长期的抑制作用。因此，开发一项第三阶段临床试验的前景是最具吸引力的，以测试局部应用10%聚维酮碘在改善治疗ECC儿童临床结果方面的有效性。然而，在开发第三阶段临床试验之前，收集额外的初步数据是有必要的。在这方面，需要对剂量数据的响应来建立10%聚维酮碘和 在第三阶段临床试验中，需要制定策略来加强受试者的保留。在此基础上，这项研究建议计划：1)建立LO%聚维酮碘溶液在牙科应用的剂量时间表；2)开发保留策略，在第三阶段临床试验中提高受试者的保留能力。

DESCRIPTION (provided by applicant): Early Childhood Caries (ECC) continues to be a public health care problem that affects babies and young pre-school children world wide. The current clinical standard of care ignores the concept that ECC is an infectious disease that is characterized by an overwhelming mutans streptococci (MS) infection and decay promoting feeding behaviors. Treatment is usually restricted to removal and restoration of carious teeth coupled with counseling regarding decay promoting feeding behaviors. Dental surgery has minimal impact on oral MS reservoirs and counseling regarding feeding habits has had minimal success. Not surprisingly, approximately 40% of children treated for ECC under general anesthesia relapse with new carious lesions within 6-12 months post treatment. Improved clinical outcomes for treatment of ECC are likely to be realized through treatment strategies that focus the infectious aspect of this disease. Suppressing oral MS reservoirs with an anti-microbial agent is a promising approach. In this regard, 10% povidone iodine is approved as a presurgical disinfectant to the skin and mucous membranes of children and preliminary data indicates that it has prolonged suppressive effects on oral MS populations even in the setting of ECC. Accordingly, the prospect of developing a Phase III clinical trial to test the efficacy of topical application of 10% povidone iodine in improving clinical outcomes for children treated for ECC is most attractive. However, prior to developing a Phase III clinical trial, gathering additional preliminary data are warranted. In this regard, response to dose data are required to establish the proper doing schedule for 10% povidone iodine and strategies need to be developed to enhance subject retention in a Phase III clinical trial. On this basis, this research proposal plans to: 1) establish a dosing schedule for the dental application of the lO% povidone iodine solution and 2) develop retention strategies that will enhance subject retention in a Phase III clinical trial.