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临床试验/NCT04785235
NCT04785235已完成不适用

The Effects of Non-Surgical Periodontal Therapy on Neutrophil Elastase and Elastase Alpha-1 Proteinase Inhibitor Levels in GCF in Periodontitis Patients With or Without Acute Coronary Syndrome

Baskent University0 个研究点目标入组 43 人开始时间: 2007年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
主要终点
GCF NE levels

研究概览

简要总结

Periodontitis may contribute to vascular damage, resulting in the destabilization of atherosclerotic plaque leading to acute coronary syndrome (ACS). In this study, we explored the effect of non-surgical periodontal treatment (NSPT) on cardiovascular blood biomarkers and gingival crevicular fluid (GCF) Neutrophil Elastase (NE) and α1-proteinase inhibitor (alpha-1PI) levels in periodontitis (P) participants with and without ACS.

Medical and dental examinations were performed to diagnose ACS and periodontitis, respectively. Seventeen patients with diagnosis ACS and periodontitis were included in this study, as a test group (Group ACS). Twenty-six, age and sex-matched control patients with periodontitis (Group P) were otherwise systemically healthy. Both groups received NSPT. Plasma levels of cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL), C-reactive protein (CRP), GCF NE activity, and GCF α1-PI levels were measured baseline, at1st and 3rd months after NSPT.

详细描述

This research was approved by the human participants ethics board of Selcuk University Faculty of Dentistry (project number=301) and was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. Informed consent was obtained from patients prior to oral diagnostic examination.

Inclusion criteria for ACS group :

• Patients diagnosed with both ACS and localized or generalized periodontitis of stage II or III with grade B or C.

The diagnosis of ACS was performed by a consultant cardiologist based on clinical signs and symptoms of cardiac ischemia, cardiac enzyme levels, changes in electrocardiography, and results of echocardiography and coronary angiography, according to the guidelines of American College of Cardiology/American Heart Association . The test group of ACS patients myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) were hospitalized in Selcuk University Meram Medical Faculty Department of Cardiology (Konya/Turkey).Unstable angina (UA) was defined as the new onset or a changed pattern of angina over the past 2 months and Canadian Cardiovascular Society (CCS) class IV angina at the time of presentation coinciding with appropriate objective evidence of myocardial ischemia on an electrocardiogram (ECG) or myocardial perfusion imaging. ACS with ST-segment elevation was defined as AMI characterized by: chest pain, radiating or not to the upper extremities, lower jaw, upper back or epigastrium lasting 30 minutes or more, associated or not with sweating, nausea or pallor; presence of ST-segment elevation of 1 mm in two or more contiguous peripheral leads or 2 mm in two or more contiguous precordial leads on electrocardiogram (ECG); and elevation in serum markers of myocardial injury and necrosis (CK, CK-MB) three times their reference value28. Non-ST-segment elevation ACS on ECG was defined as a clinical condition similar to that mentioned above but with chest pain lasting less than 30 minutes, with or without elevation of serum enzyme markers of myocardial injury and necrosis (CK, CK-MB, cardiac troponins I and T). ACS patients were referred to the Department of Periodontology, Faculty of Dentistry, Selcuk University (Konya/Turkey) for periodontal examination in a one- year period.

Inclusion criteria for control group :

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

GCF NE levels

时间窗: in 3months

Change of NE levels in ACS patients after NSPT.

GCF α1-PI

时间窗: in 3months

Change of GCF α1-PI in ACS patients after NSPT.

次要结局

  • change in NE / α1-PI rates(in 3months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilgün Özlem Alptekin

Clinical Professor

Baskent University

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