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 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。拟议 糖尿病和牙周病试验（DPT）是一项多中心、随机、对照、单盲的III期试验， 一项临床试验，旨在测试非手术牙周治疗（刮治和根面平整）是否 有效降低2型糖尿病和未经治疗的慢性牙周炎患者的HbA 1c 与没有接受初始治疗的对照组相比。延迟治疗将提供给 6个月随访后为对照组。次要目标将评估是否改善 慢性牙周炎的临床测量与全身炎症标记物的变化有关， HbA 1c和这些患者的胰岛素抵抗指标。 在两年半的时间里，来自英国医学院和牙科学院的四个临床中心 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将总共招募600名 成人（150例/中心）35岁或以上，2型糖尿病持续时间至少3个月， 未经治疗的中度至重度慢性牙周炎，HbA 1c在7.5%至9%之间，并且符合 额外的特定入选和排除标准。受试者将从糖尿病诊所招募， 每个中心的牙科诊所和社区。所有合格受试者将在基线、3- 个月和6个月;每次访视时将进行牙周检查， 测定治疗将包括局部麻醉下的刮治和根面平整。标准化 所有临床试验机构将使用通用方案和详细的程序手册。初步研究 结局为6个月时HbA 1c值的变化。次要结果是牙周的变化， 临床测量（牙龈指数、探诊出血、牙周袋深度和临床附着水平）， 炎症标志物（血清C-反应蛋白、血浆TNF和血清IL-6）的变化， 稳态模型评估（HOMA 2）的变化。这项研究有可能提供一个 提高糖尿病患者护理标准的科学依据，从而解决 2010年公共卫生服务的健康目标之一。 本申请寻求对行政中心/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。项目叙述 患有牙周（牙龈）疾病可能会使血糖控制更加困难 2型糖尿病患者的血糖水平。这项研究将测试是否非手术 牙周病治疗导致血糖控制改善。改善方式 控制血糖是预防糖尿病并发症的关键， 降低医疗费用。

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.