Periodontal DiseasesNCT04127487
Quantification of NLRP3 (rs4612666) and CARD8 Gene (rs2043211) in Generalized Chronic Periodontitis Subjects
An observational study of Periodontal Diseases and Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Periodontal Diseases, Coronary Artery Disease
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Adult, Older adult
Study population: All male patients within the age group of 30-65 years. The subjects were from south indian population
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Jaideep Mahendra
Chennai, Tamil Nadu, 600095
Jaideep Mahendra, MDS, PhD, 9444963973, jaideep_m_23@yahoo.co.in
Abirami Nayaki Rao, BDS, 9176327361, abirami.nayaki1791@gmail.com
About this study
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
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
Read the 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
- Conditions
- Periodontal Diseases, Coronary Artery Disease
- Keywords
- NLRP3 (rs4612666), CARD8 (rs20432111)
- Medical subject headings
- Periodontal Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR
Measured: 12 months
Secondary outcomes (1)
Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
- Investigators
- Jaideep Mahendra, MDS, PhD, Study director, Meenakshi Ammal Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127487
- Sponsor's protocol ID
- MADC/IRB-XXV/2018/391
- Status last verified
- Dec 2019
- First submitted
- 14 Oct 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26854620
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04127487
- Acronym / sponsor ID
- MADC/IRB-XXV/2018/391
- Conditions
- Periodontal Diseases, Coronary Artery Disease
- Keywords
- NLRP3 (rs4612666), CARD8 (rs20432111)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- All male patients within the age group of 30-65 years. The subjects were from south indian population
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
Time frame: 12 months
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene using RT-PCR
1 secondary outcome
Quantification of NLRP3 (rs4612666) and CARD8 (rs20432111) gene
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 26854620Isaza-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaideep Mahendra, MDS, PhD study director
Meenakshi Ammal Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaideep Mahendra, MDS, PhD (9444963973, jaideep_m_23@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of NLRP3 (rs4612666) and CARD8 (rs20432111) gene (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.