Prevention of Adult Caries (PACS) - Tufts Clinical Center

描述（由申请人提供）：成人龋齿，包括冠状面龋齿和根面龋齿，是一种感染性疾病，困扰着大多数55岁及以上的美国人，是中年最常见的慢性疾病。此外，成人龋齿造成显著的经济损失，并且这种经济损失持续增长。尽管龋齿的高患病率和细菌发病机制，但美国牙科专业人员还没有获得FDA批准的龋齿抗菌治疗。成人龋齿预防研究（PACS）是一项随机、双盲、安慰剂对照的III期临床试验，根据FDA新药研究许可证编号45，466进行。本研究旨在评价局部、暂时性、10%w/v氯己定牙科涂层在降低高危成人牙科患者龋齿增量方面的有效性。这项研究将在13个月的研究期内在四个中心对1000名患者进行随访，这些中心的人群差异很大。本研究的主要终点是龋齿增加。参与这项拟议研究的中心有：位于俄勒冈州波特兰的Kaiser Permanente Northwest健康研究中心;位于马萨诸塞州波士顿市中心的塔夫茨大学牙科诊所;位于马萨诸塞州南伯勒的马萨诸塞州牙科服务临床中心;以及位于亚利桑那州土巴城的土巴城区域卫生保健公司的牙科诊所。位于俄勒冈州波特兰的Kaiser Permanente健康研究中心将作为数据协调中心，塔夫茨大学将作为行政中心。Tufts临床中心的这一应用程序是支持PACS研究的协调应用程序集的一部分。有关研究方案和程序手册的完整描述，请参见管理中心申请。

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 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.