Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05314192
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2022-03-29
Brief Title:
Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients
Sponsor:
Ajman University
Organization:
Ajman University
Study Overview
Official Title:
Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Periodontitis is an immunoinflammatory disease caused by microorganisms leading to sequential loss of the supporting structures of periodontium resulting in periodontal pocket formation gingival recession eventually leading to tooth loss1 A bacterial plaque is formed during the destructive changes of the periodontium which initiates a host of inflammatory and immune responses2 These inflammatory responses may also cause an increase in inflammatory activities in atherosclerotic lesions in the coronary arteries resulting in the increased risk of cardiovascular events like myocardial infarction3 Myocardial infarction MI is a cardiovascular condition that occurs when there is deprivation of oxygen in the heart muscle is due to the sudden interruption of the blood supply resulting from the coronary artery blockage by a plaque causing myocardial ischemia and cell death Inflammation is pivotal in the initiation and progression of atherosclerosis Various cytokines and chemokines are released during inflammation4 These inflammatory markers may have diagnostic potential for the detection of various inflammatory diseases5 Macrophages secrete macrophage inflammatory protein-1 alpha MIP-1 alpha which recruits inflammatory cells inhibits stem cells and activates bone resorption cells6 Interleukin-6 IL-6 is produced in response to tissue injury and infection and contributes to the differentiation of B cells the proliferation of T cells and bone resorption7 The levels of these inflammatory markers are seen to be increased in inflammatory conditions which include myocardial infarction and stage 4 periodontitis Therefore this study aims to assess the levels of these inflammatory markers in patients with myocardial infarction and periodontitis
Detailed Description:
This was a cross-sectional study involving the patients of the department of periodontics and department of cardiology
Patients included in the study were categorized into four groups 1 group 1-healthy subjects 2 group 2-stage 4 periodontitis patients 3 group 3- post-MI patients with stage 4 periodontitis 4 group 4- post-MI patients without periodontitis
The severity of the periodontitis was assessed by a periodontist The diagnosis of acute MI was made by the cardiologists Oral health assessment in acute MI patients was done at the subjects bedside after stabilization of the patient so as not to interfere with the ongoing medical treatment Subjects identification was kept confidential
All samples were collected from patients admitted within 48 hours of their cardiac event Patients were diagnosed as acute ST-elevation myocardial infarction STEMI based on the elevation of ST segments on the electrocardiogramECG by 01mV in contiguous leads in patients with signs and symptoms of myocardial ischemia and or development of new left bundle branch block along with increased cardiac biomarkers Non-ST-elevation myocardial infarction NSTEMI was diagnosed in patients with signs and symptoms of myocardial ischemia and depression in ST-segment on the ECG or new Q wave pathology along with elevation of cardiac biomarkers8 Stage four periodontitis was diagnosed using the World Workshop 2017 classification9 Subjects who had undergone oral prophylaxis or periodontal surgery in the past 6 months were not included in the study Smokers pregnant women lactating mothers and those on medication anti-microbial non-steroidal anti-inflammatory drugs in the past 3 months as well as those with other chronic systemic diseases were excluded from the study These were all excluded as each would affect the levels of biomarkers
Patients included in the study were categorized into four groups 1 group 1-healthy subjects 2 group 2-stage 4 periodontitis patients 3 group 3- post-MI patients with stage 4 periodontitis 4 group 4- post-MI patients without periodontitis
The severity of the periodontitis was assessed by a periodontist The diagnosis of acute MI was made by the cardiologists Oral health assessment in acute MI patients was done at the subjects bedside after stabilization of the patient so as not to interfere with the ongoing medical treatment Subjects identification was kept confidential
All samples were collected from patients admitted within 48 hours of their cardiac event Patients were diagnosed as acute ST-elevation myocardial infarction STEMI based on the elevation of ST segments on the electrocardiogramECG by 01mV in contiguous leads in patients with signs and symptoms of myocardial ischemia and or development of new left bundle branch block along with increased cardiac biomarkers Non-ST-elevation myocardial infarction NSTEMI was diagnosed in patients with signs and symptoms of myocardial ischemia and depression in ST-segment on the ECG or new Q wave pathology along with elevation of cardiac biomarkers8 Stage four periodontitis was diagnosed using the World Workshop 2017 classification9 Subjects who had undergone oral prophylaxis or periodontal surgery in the past 6 months were not included in the study Smokers pregnant women lactating mothers and those on medication anti-microbial non-steroidal anti-inflammatory drugs in the past 3 months as well as those with other chronic systemic diseases were excluded from the study These were all excluded as each would affect the levels of biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None