Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583085
• Other study ID #: MADC/IRB-XXVI/2018/415
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.

Description:

The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient stage needs to be explored further. The investigators attempt to quantify and compare the levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples obtained from patients diagnosed with chronic periodontitis with and without coronary artery disease.

Seventy-five participants were selected and grouped into 3 categories; 25 patients diagnosed with chronic periodontitis and coronary artery disease: CP + CAD group; 25 patients diagnosed with chronic periodontitis alone: CP group; and 25 systemically and periodontally healthy controls (HP). Demographic variables, periodontal parameters, cardiac parameters, blood pressure were obtained. miRNA-146a and miRNA126 levels were assessed in subgingival plaque (SP) samples from all the three groups. Within CP+CAD group, SP samples of CP+CADa were compared with coronary plaques samples (CP) of CP+CADb while the patient underwent CABG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

Inclusion criteria:

• Patients volunteering for the investigation.

• Patients between the age group of 30-70 years

• Presence of = 15 natural teeth.

Exclusion criteria:

• Patients associated with systemic diseases such as lung disorders, renal disease, liver disease, type I, type II-diabetes mellitus, HIV infection, rheumatoid arthritis, allergy or any malignancy.

• Under treatment with antibiotics, immunosuppressive drugs such as corticosteroids, within 6 months.

• Pregnant women and female patients were excluded because of the altered oral flora due to hormonal changes

• Smoking and other tobacco usage habits

• Patients who underwent periodontal treatment within 6 months.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Coronary Artery Disease
• Coronary Disease
• miRNA
• Myocardial Ischemia
• Periodontitis

Locations

Country	Name	City	State
India	Meenakshi Ammal Dental college	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	micro-RNA 146-a expression in Chronic periodontitis patients with and without coronary heart disease.	microRNA 146-a expression was present in the chronic periodontitis subjects with coronary heart disease	10 months
Primary	Levels of micro-RNA 126 in chronic periodontitis patients with and without coronary heart disease	microRNA 126 expression was present in chronic periodontitis subjects with coronary heart disease	10 months