Improving Clinical Outcomes for Early Childhood Caries

改善儿童早期龋齿的临床结果

• 批准号: 6964927
• 负责人: ROBERT J BERKOWITZ
• 金额: $ 15.6万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6964927
• 关键词: Streptococcus infection; Streptococcus mutans; antiinfective agents; clinical research; dental caries; disease /disorder prevention /control; dosage; human subject; human therapy evaluation; infant human (0-1 year); iodine; microorganism disease chemotherapy; patient oriented research; polyvinylpyrrolidone; preschool child (1-5); preventive dentistry; relapse /recurrence; topical drug application

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.

描述（由申请人提供）：幼儿龋齿 (ECC) 仍然是影响全世界婴儿和学龄前儿童的公共卫生保健问题。当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) 感染和腐烂促进喂养行为。治疗通常仅限于龋齿的去除和修复，以及有关促进腐烂的喂养行为的咨询。牙科手术对口腔多发性硬化症储库的影响很小，有关饮食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 个月内复发并出现新的龋损。通过关注该疾病的传染性方面的治疗策略，可能会改善 ECC 治疗的临床结果。用抗微生物剂抑制口腔多发性硬化症储存库是一种很有前途的方法。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 期临床试验来测试局部应用 10% 聚维酮碘在改善 ECC 儿童临床结果方面的功效的前景最具吸引力。然而，在开展 III 期临床试验之前，有必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，以制定 10% 聚维酮碘和 需要制定策略来提高 III 期临床试验中受试者的保留率。在此基础上，该研究计划计划：1）建立10%聚维酮碘溶液牙科应用的给药方案，2）制定保留策略，以增强III期临床试验中受试者的保留。