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

October 9, 2020 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600095
        • Meenakshi Ammal Dental College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micro-RNA 146-a expression in Chronic periodontitis patients with and without coronary heart disease.
Time Frame: 10 months
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
Time Frame: 10 months
microRNA 126 expression was present in chronic periodontitis subjects with coronary heart disease
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meenakshi Ammal Dental College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (ACTUAL)

October 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADC/IRB-XXVI/2018/415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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