PERIODONTAL INTERVENTION FOR CARDIAC EVENTS: PILOT TRIAL

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。拟议的试点试验将涉及五个登记中心和大约225名心脏病和严重牙周病患者。本项目的目的如下：1.设计一项明确的试验，以了解牙周治疗对心脏病是否有效的问题。2.进行明确的牙周治疗在心血管事件二级预防中的临床试验。筛查后，符合条件的患者将被随机分配到治疗组或对照组，在必要时拔除无望的牙齿并更换牙齿。随机分组如下：A组(局部牙周治疗)：局部根面平整加局部局部应用缓释多西环素，安慰剂片剂每周给药一次，疗程3个月。2.B组(局部牙周治疗+全身阿奇霉素组)：局部牙周治疗+局部根面平整+局部应用缓释多西环素，在此基础上加用全身阿奇霉素600 mg，每周1次，疗程3个月。该项目为期三年，在三年结束时，将有大约225名患者参加这些治疗组(每组约75名患者)。在基线口腔检查时，符合条件的患者将完成一份详细的问卷，内容包括人口统计信息、病史、用药情况、终身体力活动、饮食历史和健康状况信息。此外，还将完成一份详细的心血管病史问卷。所有患者都将接受完整的口腔检查，包括一套标准的根尖周和咬翼牙片。将采集微生物(菌斑)、牙龈沟液、唾液和血液样本进行实验室分析。临床测量包括临床附着水平、牙龈评估、牙菌斑评估、牙石指数、探诊深度。治疗结束后，每6个月对所有患者进行一次临床检查和心血管终点损伤评估，必要时进行评估。参与者还将在其间的三个月内接受采访，使用一套标准的问题来评估任何心脏事件或不良事件，这可能是重要的。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The proposed pilot trial will be developed involving five enrollment centers and approximately 225 patients with heart disease and significant periodontal disease. The purposes of this project are as follows: 1. To design a definitive trial to understand the question of whether or not periodontal therapy will have effects on heart disease. 2. To perform a definitive clinical trial of periodontal treatment in the secondary prevention of cardiovascular events. After screening, eligible patients will be randomized to a treatment or control group after extraction of hopeless teeth and their replacement if necessary. The randomly assigned groups will be as follows: 1. Group A (Local Periodontal Therapy): Scaling and root planing plus topical, slow release doxycycline applied subgingically, and placebo tablets given once a week for three months. 2. Group B (Local Periodontal Therapy + Systemic Azithromycin): Local periodontal treatment with definitive scaling and root planing plus topical, slow release doxycycline applied subgingivally, and in addition, systemic azithromycin, one 600 mg tablets to take once a week for three months. The duration of this project is three years and approximately 225 patients will be enrolled in these treatment groups (~75 patients per group) at the end of the three years. At the time of the baseline oral examination, the eligible patients will complete a detailed questionnaire regarding demographic information, medical history, medication use, lifetime physical activity, diet history and health status information. In addition, a detailed Cardiovascular History Questionnaire will be completed. All the patients will have a complete oral examination including a standard set of periapical and bite-wing dental radiographs. Microbiological (plaque), gingival crevicular fluid, saliva and blood samples will be collected for laboratory analysis. Clinical measurements including clinical attachment level, gingival assessment, dental plaque assessment, calculus index, probing depth will be recorded. Following the treatments, all the patients will be recalled every 6 months through the study for the clinical exam and cardiovascular endpoint injury and assessment if necessary. Participants will be also called in the intervening three months to be interviewed using a standard set of questions to assess any cardiac events or adverse events, which may be important.