Diabetes and Periodontics Trial R21

糖尿病和牙周病试验 R21

• 批准号: 7145007
• 负责人: STEVEN P ENGEBRETSON
• 金额: $ 15.5万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7145007
• 关键词: clinical trials; inflammation; noninsulin dependent diabetes mellitus; periodontitis; public health; tooth

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.

描述（由申请人提供）：肥胖和2型糖尿病是美国新出现的公共卫生问题。2002年，美国糖尿病协会估计，美国糖尿病护理的直接支出为1320亿美元。血糖控制对于预防糖尿病相关的发病率和死亡率至关重要，但对于许多患者来说难以实现。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。 我们的试点研究结果是一项双盲，安慰剂对照，随机临床试验，已被其他人证实，表明非手术牙周治疗可能会降低2型糖尿病患者的HbA1c水平。 此外，拔除无望的牙齿和频繁的支持性牙周治疗方案似乎可以改善2型糖尿病的代谢管理。到目前为止，还没有足够的临床试验来解决这个问题。该申请描述了一项计划拨款，用于设计一项具有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护理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能有效改善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、纽约州斯托尼布鲁克、亚拉巴马州伯明翰、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。 受试者将在随机化前进行龋齿修复和无望牙齿拔除。受试者将被随机分配接受即刻洁治和根面平整术（试验组，n=280）或延迟洁治和根面平整术（对照组，n=280）。将为发生进行性牙周炎的所有受试者提供补救治疗。研究期间将密切监测药物治疗。受试者将接受6个月的随访。主要结局变量为糖化血红蛋白（HbA1c）。次要结果将是牙周临床指标和炎症的全身标志物。该规划补助金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，将制定一份程序手册，描述开展III期临床试验的行政结构、科学依据和详细方案。如果这项研究表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的公共卫生益处可能是巨大的。

项目成果

The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial.

• DOI: 10.1001/jama.2013.282431
• 发表时间: 2013-12-18
• 期刊: JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
• 影响因子: 120.7
• 作者: Engebretson, Steven P.;Hyman, Leslie G.;Michalowicz, Bryan S.;Schoenfeld, Elinor R.;Gelato, Marie C.;Hou, Wei;Seaquist, Elizabeth R.;Reddy, Michael S.;Lewis, Cora E.;Oates, Thomas W.;Tripathy, Devjit;Katancik, James A.;Orlander, Philip R.;Paquette, David W.;Hanson, Naomi Q.;Tsai, Michael Y.
• 通讯作者: Tsai, Michael Y.