Quantification of Micro-RNA 146-a in Chronic Periodontitis and Coronary Heart Disease Subjects

Quantification of Micro-RNA (miRNA)146-a in Subgingival Plaque Samples of Generalized Chronic Periodontitis Patients With and Without Coronary Heart Disease.

The expression and quantification of Micro-RNA 146-a, was analyzed in the subgingival plaque samples of generalized chronic periodontitis patients with and without coronary heart disease. The demographic variables and periodontal parameters were assessed and correlated with expression of micro-RNA 146-a. The quantification of levels of micro-RNA 146-a was done using Real time Polymerase chain reaction. ( RT-PCR)

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Periodontal Diseases

Detailed Description

The quantification of the levels of MicroRNA 146-a was analyzed in subgingival plaque samples of generalized chronic periodontitis subjects with and without coronary heart disease and compared them with the healthy subject.A total of 90 subjects were selected for the study and assigned to 3 groups based on inclusion and exclusion criteria. Group I comprised of 30 subjects with Generalized chronic periodontitis diagnosed with coronary heart disease.Group II comprised of 30 subjects with Generalized chronic periodontitis without coronary heart disease and Group III comprised of 30 systemically healthy volunteers with no chronic periodontitis or coronary heart disease. Demographic variables such as age, weight,height,BMI and income and clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachement levels were recorded. Subgingival plaque samples were collected from all the 3 groups. The collected samples were subject to further molecular analysis for micro-RNA expression and quantification using RT-PCR.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

All male patients within the age group of 35-65 years. The subjects were from South Indian population.

Description

Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients within the age group of 35-65 years.
3. Should have ≥ 10 natural teeth.
4. For group I Generalized chronic periodontitis patients with coronary heart disease: Generalised chronic periodontitis is defined as those having 30% or more sites with clinical attachment loss (CAL) ≥ 3mm.
5. For group II Generalized chronic periodontitis patients without coronary heart disease.
6. Healthy controls were selected based on the following criteria: Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at ≤15% of tooth sides, and no periodontal treatment (Scaling and root planning or periodontal surgery) within the previous six months.

Exclusion Criteria:

1. Patients with systemic conditions such as type I, type II and pre diabetes mellitus, respiratory diseases, renal disease, liver disease, collagenosis, rheumatoid arthritis, allergy, advanced malignancies and HIV infection were excluded from the present investigation.
2. Use of drugs such as corticosteroids, antibiotics within 6 month of investigation and immuno-suppressive chemotherapy.
3. Smokers and other behavioural factors which may influence the study.
4. Patients who had undergone periodontal therapy within the previous 6 months.
5. Female patients (due to hormonal changes and pregnancy which may alter the oral flora).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group I; 30 Generalized chronic periodontitis subjects diagnosed with Coronary heart disease.
Group II; 30 Generalized chronic periodontitis subjects without coronary heart disease.
Group III; 30 Systemically healthy patients with no chronic periodontitis or coronary heart disease.

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	Expression of Micro-RNA 146-a using real time PCR	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Micro-RNA 146-a in chronic periodontitis patients with and without coronary heart disease	Levels of Micro-RNA 146-a using real time PCR	9 months

Collaborators and Investigators

• Sponsor: Meenakshi Ammal Dental College and Hospital
• Investigators: Study Director: Jaideep Mahendra, MDS,PhD, Meenakshi Ammal Dental College

Publications and helpful links

General Publications

• Xie YF, Shu R, Jiang SY, Liu DL, Zhang XL. Comparison of microRNA profiles of human periodontal diseased and healthy gingival tissues. Int J Oral Sci. 2011 Jul;3(3):125-34. doi: 10.4248/IJOS11046.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Chronic periodontitis; Micro-RNA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stomatognathic Diseases; Mouth Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: MADC/IRB-XI/2017/225

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