Prevention of Adult Caries Study (PACS) - KP Portland Clinical Center

描述(申请人提供)：成人龋齿，包括冠状龋齿和根面龋齿，是一种传染病，困扰着大多数55岁及以上的美国人，是中年最常见的慢性病。此外，成人龋齿造成了巨大的经济损失，而且这种经济损失还在继续增长。尽管龋齿的患病率很高，而且有细菌致病，但美国牙科专业人士还没有FDA批准的抗微生物治疗龋齿的方法。预防成人龋齿研究(PACS)是一项随机、双盲、安慰剂对照的第三阶段临床试验，根据FDA新药研究许可证#45,466进行。这项研究旨在评估10%洗必泰局部临时涂膜在减少高危成人牙科患者龋病增加方面的效果。这项研究将在四个人口迥异的中心对1000名患者进行为期13个月的跟踪研究。这项研究的主要终点将是龋齿增加。参与这项拟议研究的中心包括：俄勒冈州波特兰的Kaiser Permanente Northwest健康研究中心；马萨诸塞州波士顿市中心的塔夫茨大学牙科诊所；马萨诸塞州南伯勒马萨诸塞州临床中心的牙科服务；以及亚利桑那州图巴市图巴市地区卫生保健公司的牙科诊所。位于俄勒冈州波特兰的Kaiser Permanente健康研究中心将担任数据协调中心，塔夫茨大学将担任行政中心。Kaiser Permanente波特兰临床中心的这一应用是支持PACS研究的协调应用集的一部分。有关研究方案和程序手册的完整说明，请参阅行政中心申请。

DESCRIPTION (provided by applicant): Adult dental caries, including both coronal and root caries, is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife. In addition, adult caries exacts a significant economic toll, and this economic toll continues to grow. Despite the high prevalence and bacterial pathogenesis of caries, no FDA-approved anti-microbial treatment for caries is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a randomized, double-blind, placebo-controlled Phase III clinical trial conducted under FDA Investigational New Drug license #45,466. This study is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing caries increment in at-risk adult dental patients. This study will follow 1000 patients over a 13-month study period at four centers with vastly different populations. The primary endpoint for this study will be caries increment. The centers participating in this proposed research are: Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon; Tufts University Dental Clinic in central Boston, Massachusetts; Dental Service of Massachusetts Clinical Center in Southborough, Massachusetts, and; the dental clinic of the Tuba City Regional Health Care Corporation in Tuba City, Arizona. Kaiser Permanente's Center for Health Research in Portland, Oregon will act as the data-coordinating center, and Tufts University will act as the Administrative Center. This application from the Kaiser Permanente Portland Clinical Center is part of the coordinated set of applications in support of the PACS study. Please refer to the Administrative Center Application for a complete description of the study Protocol and Manual of Procedures.