Clinical trial NCT04127487: Quantification of NLRP3 (rs4612666) and CARD8 Gene (rs2043211) in Generalized Chronic Periodontitis Subjects
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Coronary Artery Disease
Keywords: NLRP3 (rs4612666), CARD8 (rs20432111)
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 70
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
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

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

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

Eligibility 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

Primary outcomes:
measure: Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
timeFrame: 12 months
Secondary outcomes:
measure: Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
timeFrame: 12 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Jaideep Mahendra
state: Tamil Nadu
Study officials:
affiliation: Meenakshi Ammal Dental College
name: Jaideep Mahendra, MDS, PhD
role: STUDY_DIRECTOR
References:
citation: Isaza-Guzman DM, Hernandez-Viana M, Bonilla-Leon DM, Hurtado-Cadavid MC, Tobon-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.