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

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ClinicalTrials.gov Identifier: NCT04127487
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Study Description
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Brief Summary:
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

Condition or disease
Periodontal Diseases Coronary Artery Disease

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 Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Other
Time Perspective: Other
Official Title: 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
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene [ Time Frame: 12 months ]
    Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR


Secondary Outcome Measures :
  1. Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene [ Time Frame: 12 months ]
    Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male patients in the age group of 30-65 years were included. Females were excluded due to hormonal changes or pregnancy that may alter the oral flora
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127487


Contacts
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Contact: Jaideep Mahendra, MDS, PhD 9444963973 jaideep_m_23@yahoo.co.in
Contact: Abirami Nayaki Rao, BDS 9176327362 abirami.nayaki1791@gmail.com

Locations
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India
Jaideep Mahendra Recruiting
Chennai, Tamil Nadu, India, 600095
Contact: Jaideep Mahendra, MDS, PhD    9444963973    jaideep_m_23@yahoo.co.in   
Contact: Abirami Nayaki Rao, BDS    9176327361    abirami.nayaki1791@gmail.com   
Principal Investigator: Jaideep Mahendra, MDS, PhD         
Sub-Investigator: Abirami Nayaki Rao, BDS         
Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Study Director: Jaideep Mahendra, MDS, PhD Meenakshi Ammal Dental College
More Information
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Publications:

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Responsible Party: Dr.Jaideep Mahendra, Professor and PhD guide, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT04127487    
Other Study ID Numbers: MADC/IRB-XXV/2018/391
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
NLRP3 (rs4612666), CARD8 (rs20432111)
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Mouth Diseases
Stomatognathic Diseases