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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721159
• Other study ID #: MADC/IRB-XI/2017/225
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Periodontitis
• Coronary Artery Disease
• Coronary Disease
• Gingival Diseases
• Heart Diseases
• Myocardial Ischemia
• Periodontal Diseases
• Periodontitis

Locations

Country	Name	City	State
India	Meenakshi Ammal Dental college	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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