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临床试验/NCT02543502
NCT02543502已完成不适用

Treatment of Periodontal Disease in Patients With Acute Myocardial Infarction: Randomized Controlled Trial

Instituto de Cardiologia do Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2012年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
The difference in dilation measured by brachial artery blood flow

研究概览

简要总结

The main objective of this study is to evaluate the effect of treatment periodontal endothelium-dependent artery of the arm in patients with acute myocardial infarction with ST-segment elevation undergoing primary coronary intervention.

详细描述

The present work sample will be composed by individuals who suffered from ST segment elevation myocardial infarction admitted to the Cardiologic Institute from Porto Alegre. Participants period of selection and evaluation extended from August 20th, 2012 to January 2015. The whole selection was performed by the responsible researcher, assessing periodontal condition of the individuals in the hospital bed. The participants will be accompanied during the hospital stay and outpatient basis, an expected average of six months.

Clinical Exam

Patients selected for the test group will receive periodontal examination in private offices. For the clinical exam, odontoscopy (Duflex®, Brasil) and Flórida 10mm periodontal catheters measured in millimeters (Newmar®, Brasil) will be employed. The clinical exam will be performed by an experienced periodontist (the same one who will perform the patients' treatment) and will include the evaluation of parameters related to the periodontal disease, which were noted by an assistant, in a standard form (Attachment A). All permanent teeth will be examined, except for the third molars. Periodontal variables will be evaluated in four sites per tooth (vestibular, distal, lingual and mesial), according to the following:

  • Visible plaque index (VPI) - dental surfaces will be assessed by the naked eye after compressed air drying. Codes: 0 = absence of visible plaque, and 1 = presence of visible plaque (AINAMO and BAY, 1975).
  • Catheterization Depth (CD) - distance from the gingival edge to the most apical portion able to be catheterized, in millimeters.
  • Bleeding during Catheterization (BC): It will be registered the presence (score 1) or absence (score 0) of bleeding 30 seconds after measuring the catheterization depth
  • Loss of Insertion (LI): It will be calculated through the distance between the amelocemental junction to the most apical portion of the periodontal pocket. This measurement will be performed in millimeters and always rounded down to the lowest mark.

Endothelial Function Exam Endothelial function assessment will be performed through endothelial dependent dilation of the brachial artery, observed through ultrasound with a linear 3-12 MHz transducer (EnVisor CHD, Philips, Bothell, WA, USA). Automated measurements of the vase diameter will be performed with a software from the equipment used in the procedure. The evaluations will be performed in the morning period, after an 8-hour fast, in controlled temperature (22°C). After ten minutes of rest, the images of the brachial artery will be recorded with a linear transducer continuously placed over the antecubital fossa for one minute (basal). The sphygmomanometer will be placed in the arm and insufflated to the edge of 50mmHG above systolic arterial pressure for five minutes, and the alteration in the diameter of the brachial artery 60 seconds after the cuff deflation will be compared to the basal diameter. The images of the vase in the end of the diastole (identified by the R wave in the ECG) will be digitalized and recorded in 3 second gaps during the whole procedure, being subsequently analyzed offline, using the software of the equipment used in the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients admitted to our institution with a diagnosis of AMI (ST segment elevation> 0.1mV)
  • older than 30 years
  • with more than 8 teeth in the mouth
  • with advanced periodontal disease

排除标准

  • acute or chronical infection
  • impossibility of attending the following interviews and/or the periodontal treatment
  • refusing to signing the consent form
  • individuals with substance abuse
  • anticonvulsants and immunosuppressant drugs users
  • pregnant and \ or lactating women.

结局指标

主要结局

The difference in dilation measured by brachial artery blood flow

时间窗: 6 months

The primary outcome will be the difference in the dilation measured through the flow in the brachial artery by the end of six months.

次要结局

  • Major cardiovascular events(6 months)

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Sponsor

研究点 (1)

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