PERIODONTAL INTERVENTION FOR CARDIAC EVENTS: PILOT TRIAL

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。拟议的试点试验将涉及五个招募中心和大约225名患有心脏病和严重牙周病的患者。本项目的目的如下：1.设计一个明确的试验来了解牙周治疗是否对心脏病有影响。2.进行牙周治疗在心血管事件二级预防中的确定性临床试验。 筛选后，符合条件的患者将在拔除无望牙齿并在必要时进行更换后随机分配至治疗组或对照组。随机分组如下：1. A组（局部牙周病治疗）：洁治和根面平整加局部，多西环素缓释剂龈下应用，安慰剂片剂每周一次，持续三个月。 2. B组（局部牙周治疗+全身阿奇霉素）：牙周局部治疗，包括彻底洁治和根面平整术，同时局部应用多西环素缓释剂，并全身应用阿奇霉素，600 mg/片，每周1次，共3个月。 本项目的持续时间为3年，在3年结束时，这些治疗组将入组约225例患者（每组约75例患者）。在基线口腔检查时，合格患者将完成关于人口统计学信息、病史、药物使用、终生体力活动、饮食史和健康状况信息的详细问卷。此外，还将填写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科X光片。将采集微生物（菌斑）、龈沟液、唾液和血液样本进行实验室分析。将记录临床测量结果，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。治疗后，所有患者将在研究期间每6个月召回一次，进行临床检查和心血管终点损伤，并在必要时进行评估。参与者还将在中间的三个月内接受采访，使用一组标准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.