PeriodontitisNCT04172870
Evaluation of Inflammatory Markers and Periodontal Viruses on Periodontitis Patients With CAD
An observational study of Periodontitis and Coronary Artery Disease, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
Trial summary
To assess and compare the demographic variables, periodontal parameters, cardiac parameters and the expression of periodontal viruses (CMV, HSV and EBV) and inflammatory biomarkers(PTX-3, TLR-2 \& TLR-4) in periodontally healthy and generalized periodontitis patients with and without coronary artery disease(CAD). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Coronary Artery Disease
- What is being tested?
- Molecular analysis
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2018to 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Indian Population
Who may be able to join
- Patients willing to participate in the study.
- Patients with 30 to 65 years of age group
- Both genders
- Patients should have minimum of 10 natural teeth.
- In case of group III and IV patients with coronary heart disease to be included.
Who cannot join
- Patients who had undergone periodontal therapy within the previous 6 months.
- Type I and II Diabetes mellitus
- Sarcoidosis patients.
- Carcinoma patients.
- Rheumatic arthritis patients.
- Tuberculosis patients.
- Immunosuppressive conditions.
- Patients with other inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
India1 site
MeenakshiAmmal Dental College and Hospital
Chennai, Tamil Nadu, 600095
About this study
Official title: Evaluation of Demographic Variables, Clinical Parameters, Inflammatory Markers and Viruses in Periodontitis Patients With Coronary Artery Diseases
To assess and compare the demographic variables, periodontal parameters, cardiac parameters and the expression of periodontal viruses (CMV, HSV and EBV) and inflammatory biomarkers(PTX-3, TLR-2 \& TLR-4) in periodontally healthy and generalized periodontitis patients with and without coronary artery disease(CAD).
Read the detailed description
A total of 240 subjects will be recruited based on the power of the study. The selected subjects will be divided into four groups based on the inclusion and exclusion criteria.
- GROUP I: 60 healthy subjects ( No generalised periodontitis and no CAD)
- GROUP II: 60 generalised periodontitis subjects without CAD
- GROUP III: 60 CAD subjects without generalised periodontitis
- GROUP IV: 60 subjects with Generalised periodontitis and CAD
Sub-gingival plaque samples will be collected from the subjects of all the four groups. Coronary artery plaque samples will be collected from the patients who were indicated for coronary artery bypass graft surgery (CABG) among group III and group IV.
The demographic variables , periodontal parameters , cardiac parameters , expression of periodontal viruses and inflammatory biomarkers will be measured in all four groups ,
- Conditions
- Periodontitis, Coronary Artery Disease
- Being tested
- Molecular analysis
- Keywords
- Ebstein Barr Virus, Cytomegalovirus, Herpes Simplex Virus, Pentraxins, Toll Like Receptors
- Medical subject headings
- Periodontitis, Coronary Artery Disease, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular analysisDiagnostic test
RT- PCR
| Study group | Role | What they receive |
|---|---|---|
| Group I | Healthy group ( No generalised periodontitis and no CAD) Receives: Diagnostic Test: Molecular analysis | |
| Group II | Generalised periodontitis patients without CAD Receives: Diagnostic Test: Molecular analysis | |
| Group III | CAD patients without generalised periodontitis Receives: Diagnostic Test: Molecular analysis | |
| Group IV | Generalised periodontitis with CAD Receives: Diagnostic Test: Molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Virus and Inflammatory Markers expression in periodontitis patients with coronary artery disease
Expression of EBV, CMV, HSV, Pentraxins, TLR 2 and TLR 4 using PCR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start15 Nov 2018
- Primary completion1 Jul 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 (4)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
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, PhD, Principal investigator, MeenakshiAmmal Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172870
- Sponsor's protocol ID
- MADC/IRB/2017/260
- Other IDs
- FLL/IRC/01/2017
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Perio-Continuum link could be shared through publications
Publications
Gurses KM, Kocyigit D, Yalcin MU, Canpinar H, Oto MA, Ozer N, Tokgozoglu L, Guc D, Aytemir K. Enhanced Platelet Toll-like Receptor 2 and 4 Expression in Acute Coronary Syndrome and Stable Angina Pectoris. Am J Cardiol. 2015 Dec 1;116(11):1666-71. doi: 10.1016/j.amjcard.2015.08.048. Epub 2015 Sep 11.
PubMed 26455385Jenny NS, Arnold AM, Kuller LH, Tracy RP, Psaty BM. Associations of pentraxin 3 with cardiovascular disease and all-cause death: the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2009 Apr;29(4):594-9. doi: 10.1161/ATVBAHA.108.178947. Epub 2009 Jan 22.
PubMed 19164811Imbronito AV, Marcelino SL, Grande SR, Nunes FD, Romito GA. Detection of human cytomegalovirus and epstein-barr virus in coronary atherosclerotic tissue. Braz J Microbiol. 2010 Jul;41(3):563-6. doi: 10.1590/S1517-83822010000300004. Epub 2010 Sep 1.
PubMed 24031529Ilango P, Mahendra J, Mahendra L, Cherian SM, Suresh V, Mahalingam A, Khanna VV, Vummidi AV, Thanigaimalai A, Dave PH. Evidence linking the association of periodontal viruses and pentraxins in periodontitis patients with coronary artery disease. J Periodontol. 2024 Apr;95(4):325-336. doi: 10.1002/JPER.23-0096. Epub 2023 Aug 14.
PubMed 37483128
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demographic Variables, Clinical Parameters, Inflammatory Markers and Viruses in Periodontitis Patients With Coronary Artery Diseases
- ClinicalTrials.gov ID
- NCT04172870
- Acronym / sponsor ID
- MADC/IRB/2017/260
- Conditions
- Periodontitis, Coronary Artery Disease
- Keywords
- Ebstein Barr Virus, Cytomegalovirus, Herpes Simplex Virus, Pentraxins, Toll Like Receptors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 21 Nov 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.
To assess and compare the demographic variables, periodontal parameters, cardiac parameters and the expression of periodontal viruses (CMV, HSV and EBV) and inflammatory biomarkers(PTX-3, TLR-2 \& TLR-4) in periodontally healthy and generalized periodontitis patients with and without coronary artery disease(CAD).
Detailed description
A total of 240 subjects will be recruited based on the power of the study. The selected subjects will be divided into four groups based on the inclusion and exclusion criteria.
- GROUP I: 60 healthy subjects ( No generalised periodontitis and no CAD)
- GROUP II: 60 generalised periodontitis subjects without CAD
- GROUP III: 60 CAD subjects without generalised periodontitis
- GROUP IV: 60 subjects with Generalised periodontitis and CAD
Sub-gingival plaque samples will be collected from the subjects of all the four groups. Coronary artery plaque samples will be collected from the patients who were indicated for coronary artery bypass graft surgery (CABG) among group III and group IV.
The demographic variables , periodontal parameters , cardiac parameters , expression of periodontal viruses and inflammatory biomarkers will be measured in all four groups ,
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Molecular analysisHealthy group ( No generalised periodontitis and no CAD) |
| Group II | – | Diagnostic Test: Molecular analysisGeneralised periodontitis patients without CAD |
| Group III | – | Diagnostic Test: Molecular analysisCAD patients without generalised periodontitis |
| Group IV | – | Diagnostic Test: Molecular analysisGeneralised periodontitis with CAD |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Indian Population
Key inclusion criteria (5 listed)
- Patients willing to participate in the study.
- Patients with 30 to 65 years of age group
- Both genders
- Patients should have minimum of 10 natural teeth.
- In case of group III and IV patients with coronary heart disease to be included.
Key exclusion criteria (8 listed)
- Patients who had undergone periodontal therapy within the previous 6 months.
- Type I and II Diabetes mellitus
- Sarcoidosis patients.
- Carcinoma patients.
- Rheumatic arthritis patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular analysisRT- PCR | Diagnostic test | Group I, Group II, Group III, Group IV |
Primary outcome
Periodontal Virus and Inflammatory Markers expression in periodontitis patients with coronary artery disease
Time frame: 2 years
Expression of EBV, CMV, HSV, Pentraxins, TLR 2 and TLR 4 using PCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 26455385Gurses KM, Kocyigit D, Yalcin MU, Canpinar H, Oto MA, Ozer N, Tokgozoglu L, Guc D, Aytemir K. Enhanced Platelet Toll-like Receptor 2 and 4 Expression in Acute Coronary Syndrome and Stable Angina Pectoris. Am J Cardiol. 2015 Dec 1;116(11):1666-71. doi: 10.1016/j.amjcard.2015.08.048. Epub 2015 Sep 11.
- Background: PubMed 19164811Jenny NS, Arnold AM, Kuller LH, Tracy RP, Psaty BM. Associations of pentraxin 3 with cardiovascular disease and all-cause death: the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2009 Apr;29(4):594-9. doi: 10.1161/ATVBAHA.108.178947. Epub 2009 Jan 22.
- Background: PubMed 24031529Imbronito AV, Marcelino SL, Grande SR, Nunes FD, Romito GA. Detection of human cytomegalovirus and epstein-barr virus in coronary atherosclerotic tissue. Braz J Microbiol. 2010 Jul;41(3):563-6. doi: 10.1590/S1517-83822010000300004. Epub 2010 Sep 1.
- Derived from this study: PubMed 37483128Ilango P, Mahendra J, Mahendra L, Cherian SM, Suresh V, Mahalingam A, Khanna VV, Vummidi AV, Thanigaimalai A, Dave PH. Evidence linking the association of periodontal viruses and pentraxins in periodontitis patients with coronary artery disease. J Periodontol. 2024 Apr;95(4):325-336. doi: 10.1002/JPER.23-0096. Epub 2023 Aug 14.
- Individual participant dataSharing planned: No. Perio-Continuum link could be shared through publications
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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, PhD principal investigator
MeenakshiAmmal Dental College & Hospital
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 Periodontitis 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 5 inclusion and 8 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 20 Feb 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Virus and Inflammatory Markers expression in periodontitis patients with coronary artery disease (time frame: 2 years). 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 NCT04172870, which also lists 4 linked publications.
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 20 Feb 2020.