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

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ClinicalTrials.gov Identifier: NCT04583085
Recruitment Status : Completed
First Posted : October 12, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Study Description
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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.

Condition or disease
Chronic Periodontitis Coronary Artery Disease miRNA

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 Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Other
Time Perspective: Other
Official Title: Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 31, 2019

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male subjects within 30-70 years of age were selected for the study
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583085


Locations
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India
Meenakshi Ammal Dental college
Chennai, Tamil Nadu, India, 600095
Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr.Jaideep Mahendra, Professor, Director of PG education, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT04583085    
Other Study ID Numbers: MADC/IRB-XXVI/2018/415
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
Chronic Periodontitis
coronary artery disease
microRNA 146a
 microRNA 126
plaque samples
biomarkers
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases