Diabetes and Periodontics Trial - Coordinating Center

2000年卫生局局长关于口腔健康的报告确定了 牙周健康和血糖控制的改善是一个需要干预研究的领域。到 迄今为止，还没有足够的临床试验来解决这个问题。糖尿病和 牙周病学试验（DPT）是一项多中心、随机、对照、单盲的III期临床试验 旨在满足这一需求。这项研究将测试非手术牙周治疗（刮治） 和根面平整）可有效降低2型糖尿病患者和未经治疗的慢性 牙周炎相比，对照组没有接受治疗。主要研究结果将是 6个月时HbA 1c值的变化。对照组将在6- 10天后接受延迟治疗。 月访问。次要目的将评价慢性炎症临床指标的改善 牙周炎与全身炎症标志物、HbA 1c和胰岛素水平的变化有关 这些患者的抵抗力。 拟议的DPT是一项合作努力，涉及四个临床中心的学校， 阿拉巴马州伯明翰、宾夕法尼亚州费城、德克萨斯州圣安东尼奥和明尼苏达州明尼阿波利斯的医学和牙科; a 核心HbA 1c实验室，也位于明尼苏达州明尼阿波利斯市;研究主席办公室、协调中心和 核心代谢实验室，都在斯托尼布鲁克大学，斯托尼布鲁克，纽约。一个独立 数据和安全监查委员会（DSMB）将至少每年对数据进行一次评价，以评估风险 牙周治疗的好处600名符合特定资格的成人（150名/中心） 将在2.5年期间招募符合标准的受试者，并在基线、3个月和6个月时进行检查; a 所有临床试验机构都将使用标准化的通用方案和详细的程序手册。这 申请寻求对协调中心（CC）活动的支持。主要CC 职责包括：1）作为合作伙伴，提供流行病学和 组织、设计、实施和分析试验的生物统计学专业知识; 2） 表格、文件和协议的开发和分发; 3）数据责任 管理、处理和分析; 4）制定、实施和监测随机化 过程; 5）编写定期报告，以监测研究活动、安全性问题、结局和数据 DSMB的质量和其他研究委员会的常规监测报告; 6）参与 研究结果的设计、分析和发表; 7）质量保证责任 方案; 8）协调和记录DSMB会议;以及，9）与研究主席合作 协调和记录研究会议和中心之间的沟通。单独 研究主席和四个临床中心已经提交了申请。患有牙周（牙龈）疾病可能会使人们更难控制血糖水平 患有2型糖尿病这项研究将测试非手术牙周病治疗是否会导致 改善血糖控制。改善人们管理血糖的方式是预防糖尿病的关键。 糖尿病并发症和减少医疗保健费用。

The 2000 Surgeon General's Report on Oral Health identified the relationship between improvement in periodontal health and glycemic control as an area in need of intervention studies. To date there has been no adequately powered clinical trial to address this question. The Diabetes and Periodontics Trial (DPT) is a multi-center, randomized, controlled single-masked Phase III clinical trial designed to address this need. The study will test whether non-surgical periodontal therapy (scaling and root planing) is effective in reducing HbA1c of patients with type 2 diabetes and untreated chronic periodontitis compared to a control group receiving no treatment. The primary study outcome will be change in HbA1c values at 6 months. Delayed treatment will be offered to the control group after the 6- month visit. Secondary aims will evaluate whether improvement in clinical measures of chronic periodontitis is related to changes in systemic inflammatory markers, HbA1c, and measures of insulin resistance in these patients. The proposed DPT is a collaborative effort that involves four Clinical Centers from Schools of Medicine and Dentistry in Birmingham, AL; Philadelphia, PA; San Antonio, TX; and Minneapolis, MN; a Core HbA1c Laboratory, also in Minneapolis, MN; a Study Chair's office, a Coordinating Center, and a Core Metabolic Laboratory, all at Stony Brook University, Stony Brook, New York. An independent Data and Safety Monitoring Board (DSMB) will evaluate the data at least annually to assess the risks and benefits of periodontal treatment. Six hundred adults (150/center) meeting specific eligibility criteria will be enrolled over a 2.5 year period and examined at baseline, 3 and 6 months; a standardized common protocol and a detailed Manual of Procedures will be used at all centers. This application seeks support for the activities of the Coordinating Center (CC). The major CC responsibilities include: 1) serving as a collaborative partner and providing epidemiologic and biostatistical expertise to the organization, design, conduct and analysis of the trial; 2) collaborating in the development and distribution of forms, documents and protocols; 3) responsibility for data management, processing and analysis; 4) developing, implementing and monitoring the randomization process; 5) preparing periodic reports to monitor study activities, safety issues, outcomes and data quality for the DSMB and routine monitoring reports for the other study committees; 6) participating in the design, analysis and publication of the study results; 7) responsibility for quality assurance protocols; 8) coordinating and documenting DSMB meetings; and, 9) collaborating with the Study Chair to coordinate and document study meetings and communications among centers. Separate applications have been submitted by the Study Chair and the four Clinical Centers. Having periodontal (gum) disease may make it more difficult to control blood sugar levels for people with type 2 diabetes. This study will test whether non-surgical periodontal disease treatment leads to improved blood sugar control. Improving the way people manage their blood sugar is key to preventing diabetes complications and reducing health care costs.