Saffi Marco Aurélio Lumertz, Furtado Mariana Vargas, Montenegro Márlon Munhoz, Ribeiro Ingrid Webb Josephson, Kampits Cassio, Rabelo-Silva Eneida Rejane, Polanczyk Carisi Anne, Rösing Cassiano Kuchenbecker, Haas Alex Nogueira
Faculty of Dentistry, Periodontology, Federal University of Rio Grande do Sul, Ramiro Barcelos 2492, Porto Alegre 90035-003, Brazil.
Trials. 2013 Sep 6;14:283. doi: 10.1186/1745-6215-14-283.
Scarce information exists regarding the preventive effect of periodontal treatment in the recurrence of cardiovascular events. Prevention may be achieved by targeting risk factors for recurrent coronary artery disease (CAD) in patients with previous history of cardiovascular events. The aim of this trial is to compare the effect of two periodontal treatment approaches on levels of C-reactive protein, lipids, flow-mediated dilation and serum concentrations of proinflammatory and endothelial markers in stable CAD patients with periodontitis over a period of 12 months.
METHODS/DESIGN: This is a randomized, parallel design, examiner blinded, controlled clinical trial. Individuals from both genders, 35 years of age and older, with concomitant diagnosis of CAD and periodontitis will be included. CAD will be defined as the occurrence of at least one of the following events 6 months prior to entering the trial: documented history of myocardial infarction; surgical or percutaneous myocardial revascularization and lesion >50% in at least one coronary artery assessed by angiography; presence of angina and positive noninvasive testing of ischemia. Diagnosis of periodontitis will be defined using the CDC-AAP case definition (≥2 interproximal sites with clinical attachment loss ≥6 mm and ≥1 interproximal site with probing depth ≥5 mm). Individuals will have to present at least ten teeth present to be included. One hundred individuals will be allocated to test (intensive periodontal treatment comprised by scaling and root planing) or control (community periodontal treatment consisting of one session of supragingival plaque removal only) treatment groups. Full-mouth six sites per tooth periodontal examinations and subgingival biofilm samples will be conducted at baseline, 3, 6 and 12 months after treatment. The primary outcome of this study will be C-reactive protein changes over time. Secondary outcomes include levels of total cholesterol, LDL-C, HDL-C, triglycerides, IL-1β, IL-6, TNFα, fibrinogen, ICAM-1, VCAM-1 and E-selectin. These outcomes will be assessed at all time points over 12 months. Flow-mediated dilation will be assessed at baseline, 1, 3 and 6 months after periodontal therapy.
This trial will provide new evidence regarding the effect of periodontal treatment on risk markers for recurrence of cardiovascular events in stable coronary artery disease patients.
ClinicalTrials.gov Identifier, NCT01609725.
关于牙周治疗对心血管事件复发的预防作用，现有信息匮乏。对于有心血管事件既往史的患者，可通过针对复发性冠状动脉疾病（CAD）的危险因素来实现预防。本试验的目的是比较两种牙周治疗方法对稳定型CAD伴牙周炎患者在12个月内C反应蛋白水平、血脂、血流介导的血管舒张以及促炎和内皮标志物血清浓度的影响。
方法/设计：这是一项随机、平行设计、检查者盲法的对照临床试验。将纳入年龄在35岁及以上、同时诊断为CAD和牙周炎的男女个体。CAD的定义为在进入试验前6个月内发生以下至少一项事件：有记录的心肌梗死病史；外科手术或经皮心肌血运重建，且通过血管造影评估至少一条冠状动脉病变>50%；有胸痛症状且无创缺血检测呈阳性。牙周炎的诊断将使用美国疾病控制与预防中心-美国牙周病学会（CDC-AAP）病例定义（至少2个邻面位点临床附着丧失≥6mm，且至少1个邻面位点探诊深度≥5mm）。个体必须至少有10颗牙齿才能被纳入。100名个体将被分配到试验组（由龈下刮治和根面平整组成的强化牙周治疗）或对照组（仅包括一次龈上菌斑清除的社区牙周治疗）。在治疗前、治疗后3个月、6个月和12个月进行全口每颗牙齿6个位点的牙周检查和龈下生物膜样本采集。本研究的主要结局将是C反应蛋白随时间的变化。次要结局包括总胆固醇、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、甘油三酯、白细胞介素-1β（IL-1β）、白细胞介素-6（IL-6）、肿瘤坏死因子α（TNFα）、纤维蛋白原、细胞间黏附分子-1（ICAM-1）、血管细胞黏附分子-1（VCAM-1）和E选择素的水平。这些结局将在12个月内的所有时间点进行评估。血流介导的血管舒张将在牙周治疗前、治疗后1个月、3个月和6个月进行评估。
本试验将为牙周治疗对稳定型冠状动脉疾病患者心血管事件复发风险标志物的影响提供新的证据。
ClinicalTrials.gov标识符，NCT01609725。
