Prevention of Adult Caries (PACS) - Tufts Clinical Center

成人龋齿，包括冠状龋齿和根面龋齿，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。尽管流行率很高， 龋病的细菌致病机制，目前尚无FDA批准的抗菌剂治疗龋病 美国牙科专业人士。成人龋齿预防研究(PACS)是一项随机、双盲、 根据FDA研究新药许可证#45,466进行的安慰剂对照第三阶段临床试验。 这项研究旨在评估10%w/v洗必泰牙科局部涂膜的疗效。 在减少高危成人牙科患者的龋齿增加方面。这项研究将对1000名患者进行13- 在四个人口差异很大的中心进行了一个月的研究。这项研究的主要终点是 是龋病增多。参与这项拟议研究的中心包括：健康研究中心、 位于俄勒冈州波特兰的Kaiser Permanente Northwest；位于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牙科服务 亚利桑那州图巴市的图巴市地区医疗保健公司的牙科诊所。Kaiser Permanente的 俄勒冈州波特兰的健康研究中心将担任数据协调中心，塔夫茨大学 将作为行政中心。 塔夫茨临床中心的这一应用程序是支持 PAC研究。有关这项研究的完整说明，请参阅行政中心申请 规程和程序手册。

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.