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

NCT04583085 | Completed

• 1 other identifier: MADC/IRB-XXVI/2018/415
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Periodontitis; Coronary Artery Disease; miRNA

Keywords

Chronic Periodontitis; coronary artery disease; microRNA 146a; microRNA 126; plaque samples; biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

CP + CHD group

This was further divided into CP + CHDa (Subgingival plaque) and CP + CHDb (Coronary plaque) based on the nature of plaque collected.

CP group

25 patients with chronic periodontitis who were systemically healthy were selected

HP group

25 patients who were systemically and periodontally healthy, were considered as HP group.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Only male patients in the age group of 30-70 years were included. Females were excluded due to hormonal changes or pregnancy that may alter the oral flora
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male subjects within 30-70 years of age were selected for the study

You may qualify if:

• Patients volunteering for the investigation.
• Patients between the age group of 30-70 years
• Presence of ≥ 15 natural teeth.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Meenakshi Ammal Dental college

Chennai, Tamil Nadu, 600095, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of PG education

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 12, 2020
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)