Diabetes and Periodontics Trial - Administrative Center/Study Chair

摘要 2000年卫生局局长关于口腔健康的报告确定了 改善牙周健康和血糖控制是一个需要干预研究的领域。至 迄今为止，还没有足够有力的临床试验来解决这个问题。建议数 糖尿病和牙周病试验(DPT)是一项多中心、随机、对照的单盲III期试验 临床试验旨在测试非手术牙周治疗(去垢和根面平整)是否有效 有效降低2型糖尿病合并慢性牙周炎初治患者糖化血红蛋白 与不接受任何初步治疗的对照组相比。延迟治疗将被提供给 对照组于随访6个月后复诊。次级目标将评估是否改善了 慢性牙周炎的临床指标与全身炎症标志物的变化有关， 糖化血红蛋白，以及这些患者的胰岛素抵抗的测量。 在两年半的时间里，来自医学和牙科学院的四个临床中心 亚利桑那州伯明翰、宾夕法尼亚州费城、德克萨斯州圣安东尼奥和明尼阿波利斯明尼阿波利斯将招聘600名 成年人(150个/中心)35岁或以上，2型糖尿病病程至少3个月， 未经治疗的中至重度慢性牙周炎，糖化血红蛋白在7.5%至9%之间，谁符合 其他具体的纳入和排除标准。受试者将从糖尿病诊所招募， 每个中心的牙科诊所和社区。所有符合资格的受试者将在基线上进行检查，3- 6个月和6个月；每次就诊将进行牙周检查和HbA1c值 下定决心。治疗将包括局部麻醉下的刮治和根面平整。一个标准化的 所有中心都将使用共同协议和详细的程序手册。初步研究 结果将是6个月时HbA1c值的变化。次要结果是牙周的改变 临床测量(牙龈指数、探诊出血、口袋深度和临床附着水平)， 炎症标志物(血清C反应蛋白、血浆肿瘤坏死因子和血清IL-6)和 稳态模型评估(HOMA2)的变化。这项研究有可能提供一种 改善糖尿病患者护理标准的科学依据，从而解决 这是公共卫生服务机构2010年的健康人群目标之一。 此应用程序寻求对行政中心/研究主席的支持。单独的应用程序 已由协调中心和四个临床中心提交。项目叙事 患牙周病可能会增加控制血糖的难度 2型糖尿病患者的血药浓度。这项研究将测试非手术治疗 牙周病的治疗可以改善血糖控制。改进工作方式 人们控制自己的血糖是预防糖尿病并发症和 降低医疗成本。

Abstract 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 proposed Diabetes and Periodontics Trial (DPT) is a multi-center, randomized, controlled single-masked Phase III clinical trial designed to 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 who will receive no initial treatment. Delayed treatment will be offered to the control group after the 6-month visit. The secondary aims will evaluate whether improvement in clinical measures of chronic periodontitis are related to changes in systemic inflammatory markers, HbA1c, and measures of insulin resistance in these patients. Over a two and a half year period, four Clinical Centers from Schools of Medicine and Dentistry in Birmingham, AL, Philadelphia, PA, San Antonio, TX, and Minneapolis, MN will recruit a total of 600 adults (150/center) 35 years of age or older, with type 2 diabetes of at least 3 months duration, untreated moderate to severe chronic periodontitis, HbA1c between 7.5% and 9%, and who meet additional specific inclusion and exclusion criteria. Subjects will be recruited from the diabetes clinics, dental clinics and communities at each center. All eligible subjects will be examined at baseline, 3- months, and 6-months; at each visit a periodontal examination will be conducted and HbA1c values determined. Treatment will consist of scaling and root planing under local anesthetic. A standardized common protocol, and a detailed Manual of Procedures will be used at all centers. The primary study outcome will be change in HbA1c values at 6-months. Secondary outcomes are changes in periodontal clinical measures (gingival index, bleeding on probing, pocket depths, and clinical attachment levels), changes in inflammatory markers (serum C-reactive protein, plasma TNF, and serum IL-6) and changes in the Homeostasis Model Assessment (HOMA2). This study has the potential to provide a scientific basis for an improvement in the standard of care for patients with diabetes thus addressing one of the Public Health Service's Healthy People 2010 goals. This application seeks support for the Administrative Center/Study Chair. Separate applications have been submitted by the Coordinating Center, and four Clinical Centers. Project Narrative 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.