Prevention of Adult Caries (PACS) - Tufts Clinical Center

描述（由申请人提供）：成人龋齿，包括冠状和根状龋齿，是一种困扰大多数55岁及以上美国人的感染性疾病，是中年人最常见的慢性疾病。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加。尽管龋齿的发病率高且由细菌致病，但美国牙科专业人员还没有获得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III期临床试验，根据FDA新药研究许可#45,466进行。本研究旨在评估局部、临时、10% w/v氯己定牙涂层在减少高危成年牙科患者龋齿增加方面的疗效。这项研究将在四个中心对1000名患者进行为期13个月的跟踪研究，这些中心的人群差异很大。本研究的主要终点是龋齿增量。参与这项拟议研究的中心是：俄勒冈州波特兰市凯撒医疗机构西北健康研究中心；马萨诸塞州波士顿市中心的塔夫茨大学牙科诊所；马萨诸塞州南伯勒临床中心牙科服务；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市的Kaiser Permanente健康研究中心将作为数据协调中心，而塔夫茨大学将作为行政中心。这个来自塔夫茨临床中心的应用程序是支持PACS研究的协调应用程序集的一部分。请参阅行政中心申请，了解研究方案和程序手册的完整描述。

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 Tufts 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.