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NCT04172870 Clinical Trial

Evaluation of Inflammatory Markers and Periodontal Viruses on Periodontitis Patients With CAD

Coronary Artery Disease Clinical Trial

Official title:
Evaluation of Demographic Variables, Clinical Parameters, Inflammatory Markers and Viruses in Periodontitis Patients With Coronary Artery Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04172870
Other study ID # MADC/IRB/2017/260
Secondary ID FLL/IRC/01/2017
Status Active, not recruiting
Phase
First received
Last updated
Start date November 15, 2018
Est. completion date December 1, 2020

Study information
Verified date February 2020
Source Meenakshi Ammal Dental College and Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).

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.

1. GROUP I: 60 healthy subjects ( No generalised periodontitis and no CAD)

2. GROUP II: 60 generalised periodontitis subjects without CAD

3. GROUP III: 60 CAD subjects without generalised periodontitis

4. 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 ,

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 240
Est. completion date December 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

1. Patients willing to participate in the study.

2. Patients with 30 to 65 years of age group

3. Both genders

4. Patients should have minimum of 10 natural teeth.

5. In case of group III and IV patients with coronary heart disease to be included.

Exclusion Criteria

1. Patients who had undergone periodontal therapy within the previous 6 months.

2. Type I and II Diabetes mellitus

3. Sarcoidosis patients.

4. Carcinoma patients.

5. Rheumatic arthritis patients.

6. Tuberculosis patients.

7. Immunosuppressive conditions.

8. Patients with other inflammatory diseases.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Molecular analysis
RT- PCR

Locations
Country Name City State
India MeenakshiAmmal Dental College and Hospital Chennai TamilNadu

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

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

Imbronito 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. — View Citation

Jenny 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years
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