Clinical trial NCT04583085: Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease
Official title: Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Periodontitis
Coronary Artery Disease
miRNA
Keywords: Chronic Periodontitis
coronary artery disease
microRNA 146a
microRNA 126
plaque samples
biomarkers
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 75
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male subjects within 30-70 years of age were selected for the study

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.

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.

Eligibility 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.

Primary outcomes:
measure: micro-RNA 146-a expression in Chronic periodontitis patients with and without coronary heart disease.
timeFrame: 10 months
measure: Levels of micro-RNA 126 in chronic periodontitis patients with and without coronary heart disease
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Meenakshi Ammal Dental college
state: Tamil Nadu
Study officials:
References: