- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04127487
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 Contact
- Name: Jaideep Mahendra, MDS, PhD
- Phone Number: 9444963973
- Email: jaideep_m_23@yahoo.co.in
Study Contact Backup
- Name: Abirami Nayaki Rao, BDS
- Phone Number: 9176327362
- Email: abirami.nayaki1791@gmail.com
Study Locations
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India, 600095
- Recruiting
- Jaideep Mahendra
-
Contact:
- Jaideep Mahendra, MDS, PhD
- Phone Number: 9444963973
- Email: jaideep_m_23@yahoo.co.in
-
Principal Investigator:
- Jaideep Mahendra, MDS, PhD
-
Contact:
- Abirami Nayaki Rao, BDS
- Phone Number: 9176327361
- Email: abirami.nayaki1791@gmail.com
-
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.
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.
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
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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