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NCT04127487 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04127487
Other study ID # MADC/IRB-XXV/2018/391
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date December 1, 2020

Study information
Verified date December 2019
Source Meenakshi Ammal Dental College and Hospital
Contact Jaideep Mahendra, MDS, PhD
Phone 9444963973
Email jaideep_m_23@yahoo.co.in
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date December 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers
Gender Male
Age group 30 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Jaideep Mahendra Chennai Tamil Nadu

Sponsors (1)
Lead Sponsor Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

Isaza-Guzmán DM, Hernández-Viana M, Bonilla-León DM, Hurtado-Cadavid MC, Tobón-Arroyave SI. Determination of NLRP3 (rs4612666) and IL-1B (rs1143634) genetic polymorphisms in periodontally diseased and healthy subjects. Arch Oral Biol. 2016 May;65:44-51. doi: 10.1016/j.archoralbio.2016.01.013. Epub 2016 Jan 27. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR 12 months
Secondary Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR 12 months
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