Improving Clinical Outcomes for Early Chilhood Caries

描述（由申请人提供）：幼儿龋齿（ECC）仍然是一个公共卫生保健问题，影响世界各地的婴儿和幼儿学龄前儿童。目前的临床护理标准忽略了ECC是一种传染病的概念，其特征是压倒性的变形链球菌（MS）感染和腐烂促进进食行为。治疗通常仅限于去除和修复龋齿，并就促进进食行为的蛀牙进行咨询。牙科手术对口腔MS储库的影响最小，关于喂养习惯的咨询也收效甚微。毫不奇怪，大约40%在全身麻醉下接受ECC治疗的儿童在治疗后6-12个月内复发，出现新的龋损。通过关注这种疾病的感染方面的治疗策略，可能会改善ECC治疗的临床结局。用抗微生物剂抑制口腔MS储库是一种有前途的方法。在这方面，10%聚维酮碘被批准作为儿童皮肤和粘膜的术前消毒剂，初步数据表明， 即使在ECC的情况下，对口腔MS人群也具有长期的抑制作用。因此，开展III期临床试验以测试局部应用10%聚维酮碘改善ECC治疗儿童临床结局的疗效的前景最具吸引力。然而，在开展III期临床试验之前，需要收集额外的初步数据。在这方面，需要对剂量数据做出反应，以确定10%聚维酮碘的适当给药时间表， 需要开发策略以提高III期临床试验中的受试者保留率。在此基础上，本研究计划：1）建立10%聚维酮碘溶液牙科应用的给药方案和2）开发将在III期临床试验中增强受试者保留的保留策略。

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.