Prevention of Adult Caries Study (PACS) Tuba City Clinical Center

成人龋齿预防研究 (PACS) 图巴市临床中心

• 批准号: 7643312
• 负责人: Gerardo Maupome
• 金额: $ 1.97万
• 依托单位: TUBA CITY REGIONAL HEALTH CARE CORP
• 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 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7643312
• 关键词: Adult; American; Area; Arizona; Boston; Caring; Chlorhexidine; Chronic Disease; Cities; Clinical; Communicable Diseases; Communities; Comprehensive Health Care; Data Coordinating Center; Dental; Dental Care; Dental Clinics; Dental caries; Double-Blind Method; Economics; FDA approved; Health; Healthcare; High Prevalence; Investigational Drugs; Licensing; Manuals; Massachusetts; Navajo; Oregon; Participant; Pathogenesis; Patients; Phase III Clinical Trials; Placebo Control; Population; Prevention; Procedures; Protocols documentation; Randomized; Research; Risk; Root Caries; Universities; aged; antimicrobial; design; middle age; prevent

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 Tuba City 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）：成人龋齿，包括冠龋和根龋，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疾病。此外，成人龋齿造成巨大的经济损失，而且这种经济损失还在继续增长。尽管龋齿的患病率很高并且是由细菌引起的，但美国牙科专业人士还没有获得 FDA 批准的针对龋齿的抗微生物治疗方法。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 #45,466 进行。本研究旨在评估局部、临时、10% w/v 氯己定牙科涂层在减少高危成人牙科患者龋齿增量方面的功效。这项研究将在 13 个月的研究期内对四个中心的 1000 名患者进行跟踪，这些患者的人群差异很大。这项研究的主要终点是龋齿增加。参与这项拟议研究的中心包括： 俄勒冈州波特兰市 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；位于马萨诸塞州绍斯伯勒的马萨诸塞州临床中心的牙科服务；亚利桑那州图巴市图巴市地区医疗保健公司的牙科诊所。位于俄勒冈州波特兰的凯撒医疗机构健康研究中心将充当数据协调中心，塔夫茨大学将充当行政中心。图巴市临床中心的此应用程序是支持 PACS 研究的协调应用程序集的一部分。请参阅管理中心申请表，了解研究方案和程序手册的完整说明。