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

• Sponsor: Meenakshi Ammal Dental College and Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04172870
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Periodontitis; Coronary Artery Disease	Diagnostic Test: Molecular analysis

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 ,

Study Design

• Study Type: Observational
• Actual Enrollment: 240 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Demographic Variables, Clinical Parameters, Inflammatory Markers and Viruses in Periodontitis Patients With Coronary Artery Diseases
• Actual Study Start Date: Nov 15, 2018
• Anticipated Primary Completion Date: Jul 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group I Healthy group ( No generalised periodontitis and no CAD)	Diagnostic Test: Molecular analysis; RT- PCR
Group II Generalised periodontitis patients without CAD	Diagnostic Test: Molecular analysis; RT- PCR
Group III CAD patients without generalised periodontitis	Diagnostic Test: Molecular analysis; RT- PCR
Group IV Generalised periodontitis with CAD	Diagnostic Test: Molecular analysis; RT- PCR

Outcome Measures

Primary Outcome Measures

1. Periodontal Virus and Inflammatory Markers expression in periodontitis patients with coronary artery disease [2 years]

   Expression of EBV, CMV, HSV, Pentraxins, TLR 2 and TLR 4 using PCR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MeenakshiAmmal Dental College and Hospital	Chennai	TamilNadu	India	600095

Sponsors and Collaborators

• Meenakshi Ammal Dental College and Hospital

Investigators

• Principal Investigator: Jaideep Mahendra, PhD, MeenakshiAmmal Dental College & Hospital

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.

• Responsible Party: Dr.Jaideep Mahendra, Professor and Director of PG studies, Meenakshi Ammal Dental College and Hospital
• ClinicalTrials.gov Identifier: NCT04172870
• Other Study ID Numbers: MADC/IRB/2017/260; FLL/IRC/01/2017
• First Posted: Nov 21, 2019
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr.Jaideep Mahendra, Professor and Director of PG studies, Meenakshi Ammal Dental College and Hospital: Ebstein Barr Virus; Cytomegalovirus; Herpes Simplex Virus; Pentraxins; Toll Like Receptors
• Additional relevant MeSH terms: Periodontitis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Feb 20, 2020