Diabetes and Periodontics Trial R21

描述（由申请人提供）：肥胖和2型糖尿病是美国新兴的公共卫生问题。2002年，美国糖尿病协会估计美国用于糖尿病治疗的直接支出为1320亿美元。血糖控制对预防糖尿病相关的发病率和死亡率至关重要，但对许多患者来说很难实现。血糖控制不良与慢性牙周炎有关，初步证据表明牙周治疗可改善血糖控制。我们的初步研究是一项双盲、安慰剂对照、随机临床试验，其结果得到了其他研究的证实，表明非手术牙周治疗可以降低2型糖尿病患者的HbA1c水平。此外，拔牙疗法和频繁的牙周支持治疗似乎可以改善2型糖尿病的代谢管理。迄今为止，还没有足够有力的临床试验来解决这个问题。本申请描述了一项计划拨款，旨在设计一项足够样本量的随机、多中心临床试验，以测试牙周治疗是否在糖尿病治疗中发挥有意义的作用。拟议的临床试验的目的是测试牙周治疗是否有效地改善2型糖尿病和未经治疗的牙周炎患者的代谢管理。该临床试验将招募560名患有2型糖尿病和未经治疗的牙周炎的成年人。志愿者将从六个地理和种族不同的人群中招募；纽约州纽约市、纽约州石溪、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。受试者将在随机分组前进行龋齿修复，并拔牙。受试者将被随机分配接受立即刮治和根刨（试验组，n=280）或延迟刮治和根刨（对照组，n=280）。所有经历进行性牙周炎的受试者都将接受抢救治疗。在研究期间将密切监测医疗和药物。受试者将被随访六个月。主要结局变量将是糖化血红蛋白（HbA1c）。次要结果将是牙周临床测量和全身炎症标志物。这项计划拨款的目的是为拟议的临床试验制定方案。在拟议的一年规划期内，将编写一份程序手册，其中描述了进行第三阶段临床试验的行政结构、科学原理和详细方案。如果这项研究证明牙周治疗可以改善血糖控制，那么这种相对温和的治疗在降低发病率方面对公众健康的好处可能是巨大的。

DESCRIPTION (provided by applicant): Obesity and type 2 diabetes are emerging public health concerns in the United States. In 2002, the American Diabetes Association estimated that direct expenditures for diabetes care in the United States were 132 billion dollars. Glycemic control is essential to the prevention of diabetes-related morbidity and mortality, yet is difficult to achieve for many patients. Poor glycemic control is associated with chronic periodontitis and preliminary evidence suggests that periodontal treatment improves glycemic control. Results from our pilot study a double-blind, placebo-controlled, randomized clinical trial, which has been corroborated by others, suggest that non-surgical periodontal therapy may reduce HbA1c levels in individuals with type 2 diabetes. Also, a regimen of extracting hopeless teeth, and frequent supportive periodontal therapy, appears to improve the metabolic management of type 2 diabetes. To date there has been no adequately powered clinical trial to address this question. This application describes a planning grant to design a randomized, multi-center clinical trial of sufficient sample size that will test if periodontal therapy plays a meaningful role in diabetes care. The aims of the proposed clinical trial will be to test whether periodontal treatment is effective in improving the metabolic management of patients with type 2 diabetes and untreated periodontitis. The clinical trial will enroll 560 adults with type 2 diabetes and untreated periodontitis. Volunteers will be recruited from six geographically and ethnically diverse populations; New York City, NY, Stony Brook, NY, Birmingham, Alabama, Philadelphia, Pennsylvania, San Antonio, Texas, and Minneapolis, Minnesota. Subjects will have their dental caries restored, and hopeless teeth extracted prior to randomization. Subjects will be randomly assigned to receive immediate scaling and root planing (Test group, n=280) or, delayed scaling and root planing, (Control group, n=280). Rescue therapy will be provided for all subjects who experience progressive periodontitis. Medical treatment and medications will be closely monitored during the study. Subjects will be followed for six months. The primary outcome variable will be glycated hemoglobin (HbA1c). Secondary outcomes will be periodontal clinical measures and systemic markers of inflammation. The aims of this planning grant are to develop the protocol for the proposed clinical trial. During the proposed one-year planning period, a manual of procedures will be developed, that describes an administrative structure, scientific rationale and detailed protocol to carry out a phase 3 clinical trial. If this study demonstrates that periodontal therapy leads to improved glycemic control, the public health benefit in terms of reduced morbidity from this relatively modest treatment could be substantial.