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

NCT03721159 | Completed

• 1 other identifier: MADC/IRB-XI/2017/225
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Periodontal Diseases; Coronary Disease

Keywords

Micro-RNA; Chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Levels of Micro-RNA 146-a in chronic periodontitis patients with and without coronary heart disease

  9 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Only male patients in the age group of 35-65 years were included. Females were excluded due to hormonal changes or pregnancy that may alter the oral flora
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients willing to participate in the study.
• Patients within the age group of 35-65 years.
• Should have ≥ 10 natural teeth.
• 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.
• For group II Generalized chronic periodontitis patients without coronary heart disease.
• 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.

You may not qualify if:

• 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.
• Use of drugs such as corticosteroids, antibiotics within 6 month of investigation and immuno-suppressive chemotherapy.
• Smokers and other behavioural factors which may influence the study.
• Patients who had undergone periodontal therapy within the previous 6 months.
• Female patients (due to hormonal changes and pregnancy which may alter the oral flora).

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Meenakshi Ammal Dental college

Chennai, Tamil Nadu, 600095, India

Location

Related 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.

  PMID: 21789961 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Coronary Disease; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaideep Mahendra, MDS,PhD

  Meenakshi Ammal Dental College

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and PhD guide

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: October 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)