Quantification of NLRP3 (rs4612666) and CARD8 Gene (rs2043211) in Generalized Chronic Periodontitis Subjects

December 1, 2019 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Quantification of NLRP3 (rs4612666) and CARD8 Gene (rs2043211) in Subgingival Plaque and Blood Samples of Generalized Chronic Periodontitis Subjects With and Without Coronary Heart Disease

Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) will be analysed in the subgingival plaque and blood samples of generalized chronic periodontitis with and without coronary heart disease. The demographic and the periodontal parameters were assessed and correlated with the quantification of NLRP3 (rs4612666) and CARD8 (rs2043211) was analysed with RT-PCR

Study Overview

Status

Unknown

Conditions

Detailed Description

The study is done in order to assess the demographic variables such as age, height, weight and socio-economic status, BMI, personal habits, waist-hip ratio, lipid profile, use of medications, and family history of coronary artery disease in generalised chronic periodontitis subjects with and without coronary artery disease. To assess and compare the periodontal status of generalised chronic periodontitis subjects with and without coronary artery disease. To determine the expression of NLRP3 (rs4612666) and CARD8 gene (rs2043211) polymorphisms in subgingival tissue samples of generalised chronic gingivitis periodontitis subjects with and without coronary artery disease. To correlate the demographic variables and periodontal parameters and the expression of NLRP3 (rs4612666) and CARD8 (rs2043211) gene polymorphisms in generalised chronic periodontitis patients with coronary artery disease and compare them with systemically healthy chronic periodontitis patients

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600095
        • Recruiting
        • Jaideep Mahendra
        • Contact:
        • Principal Investigator:
          • Jaideep Mahendra, MDS, PhD
        • Contact:
        • Sub-Investigator:
          • Abirami Nayaki Rao, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

All male patients within the age group of 30-65 years. The subjects were from south indian population

Description

Inclusion Criteria:

  • Patients willing to participate in the study
  • Patients within the age group of 30-65 years ( male )
  • Patients should have ≥ 20 remaining natural teeth
  • No history of long term antibiotic use in the past 6 months
  • For group I generalized chronic periodontitis patients with coronary heart disease
  • For group II generalized chronic periodontitis patients without coronary heart disease

Exclusion criteria:

  • Patients with systemic conditions such as type I, and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and hiv infection will be excluded from the present investigation.
  • Patients on drugs such as corticosteroids, antibiotics within 3 months of investigation will be excluded.
  • Current smokers, individuals who quit smoking less than 6 months ago.
  • Patients who had undergone periodontal therapy within the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Periodontitis group
35 Generalized chronic periodontitis subjects without coronary heart diseases
periodontitis with CAD group
35 Generalized chronic periodontitis subjects diagnosed with Coronary heart disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
Time Frame: 12 months
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
Time Frame: 12 months
Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meenakshi Ammal Dental College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (ACTUAL)

October 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADC/IRB-XXV/2018/391

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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