Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients

NCT05314192 | Completed DMC

• 1 other identifier: ABSM/EC/29/2020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 loss.\[1\] A bacterial plaque is formed during the destructive changes of the periodontium which initiates a host of inflammatory and immune responses.\[2\] 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 infarction.\[3\] 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 inflammation.\[4\] These inflammatory markers may have diagnostic potential for the detection of various inflammatory diseases.\[5\] Macrophages secrete macrophage inflammatory protein-1 alpha (MIP-1 alpha) which recruits inflammatory cells, inhibits stem cells, and activates bone resorption cells.\[6\] 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 resorption.\[7\] 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.

Conditions

Myocardial Infarction; Periodontal Diseases

Keywords

MIP-1 Alpha; IL-6; Myocardial infarction; Periodontal disease

Outcome Measures

Primary Outcomes (2)

• salivary test for MIP-1 alpha

  saliva was assessed for biomarker MIP-1 alpha among the 4 groups

  72 hours

• salivary test for IL-6

  saliva was assessed for biomarker IL-6 among the 4 groups

  72 hours

Study Arms (4)

Healthy

Healthy cohorts with no underlying systemic or periodontal disease

Diagnostic Test: salivary test

stage 2 periodontitis

patients with periodontitis but no underlying systemic periodontal disease

Diagnostic Test: salivary test

MI patients with stage 4 periodontitis

patients who had MI and having stage 4 periodontitis patients

Diagnostic Test: salivary test

MI patients without periodontitis

patients who had MI without periodontitis

Diagnostic Test: salivary test

Interventions

salivary test DIAGNOSTIC_TEST

saliva was assessed for MIP-1 alpha

Healthy; MI patients with stage 4 periodontitis; MI patients without periodontitis; stage 2 periodontitis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• subjects who had MI
• who had stage 4 periodontal disease

You may not qualify if:

• subjects who did not have MI
• subjects who had systemic disease other than MI
• subjects who had medication in the past 3 months
• smokers
• pregnant and lactating women

Sponsors & Collaborators

• Ajman University: lead
• A B Shetty Memorial Institute of Dental Science: collaborator

Study Sites (1)

AB shetty Institute of dental sciences

Mangalore, India

Location

MeSH Terms

Conditions

Myocardial Infarction; Periodontal Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: March 1, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 20, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

IN (1)