Clinical trial NCT04172870: Evaluation of Inflammatory Markers and Periodontal Viruses on Periodontitis Patients With CAD
Official title: Evaluation of Demographic Variables, Clinical Parameters, Inflammatory Markers and Viruses in Periodontitis Patients With Coronary Artery Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Coronary Artery Disease
Keywords: Ebstein Barr Virus
Cytomegalovirus
Herpes Simplex Virus
Pentraxins
Toll Like Receptors
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indian Population

Brief 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).

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.

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 ,

Eligibility criteria: 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.

Primary outcomes:
measure: Periodontal Virus and Inflammatory Markers expression in periodontitis patients with coronary artery disease
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: MeenakshiAmmal Dental College and Hospital
state: TamilNadu
Study officials:
affiliation: MeenakshiAmmal Dental College & Hospital
name: Jaideep Mahendra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.