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

成人龋齿预防研究 (PACS) - KP 波特兰临床中心

• 批准号: 7434557
• 负责人: JOHN J SNYDER
• 金额: $ 58.2万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-15 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7434557
• 关键词: Adult; American; Arizona; Boston; Chlorhexidine; Chronic Disease; Cities; Clinical; Communicable Diseases; Conduct Clinical Trials; Country; Data Coordinating Center; Dental; Dental Care; Dental Clinics; Dental caries; Double-Blind Method; Economics; End Point; Health; Healthcare; High Prevalence; Investigational Drugs; Licensing; Manuals; Massachusetts; Oregon; Participant; Pathogenesis; Patients; Phase III Clinical Trials; Placebo Control; Population; Prevention; Procedures; Protocols documentation; Randomized; Research; Risk; Root Caries; Services; United States Food and Drug Administration; Universities; aged; antimicrobial; design; member; middle age; programs

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.

描述（由申请人提供）：成年龋齿，包括冠状动脉和根源龋齿，是一种感染性疾病，折磨于55岁及以上的大多数美国人，是中年最常见的慢性疾病。此外，成年龋齿造成了巨大的经济损失，这种经济损失继续增长。尽管龋齿的患病率很高和细菌发病机理，但美国牙科专业人员尚无FDA批准的抗微生物治疗。成人龋齿研究（PACS）是一项随机，双盲，安慰剂控制的III期临床试验，该试验根据FDA研究性新药许可证＃45,466进行。这项研究旨在评估局部，临时，10％w/v的氯己定牙涂层在减少高危成年牙科患者中龋齿增量方面的疗效。这项研究将在13个月的研究期间在四个中心的1000名患者进行截然不同的患者。这项研究的主要终点是龋齿增加。参加这项拟议的研究的中心是：卫生研究中心，俄勒冈州波特兰的Kaiser Permanente Northwest；马萨诸塞州波士顿市中心的塔夫茨大学牙科诊所；马萨诸塞州南伯勒的马萨诸塞州临床中心的牙科服务，以及；亚利桑那州图巴市的Tuba City地区卫生保健公司的牙科诊所。俄勒冈州波特兰市的Kaiser Permanente卫生研究中心将充当数据协调中心，塔夫茨大学将担任行政中心。 Kaiser Permanente Portland临床中心的应用是支持PACS研究的协调应用程序的一部分。请参阅行政中心申请，以完整描述研究协议和程序手册。