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

NCT ID: NCT04172870

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-12-01

Brief Summary

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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

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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 ,

Conditions

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Periodontitis Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I

Healthy group ( No generalised periodontitis and no CAD)

Molecular analysis

Intervention Type DIAGNOSTIC_TEST

RT- PCR

Group II

Generalised periodontitis patients without CAD

Molecular analysis

Intervention Type DIAGNOSTIC_TEST

RT- PCR

Group III

CAD patients without generalised periodontitis

Molecular analysis

Intervention Type DIAGNOSTIC_TEST

RT- PCR

Group IV

Generalised periodontitis with CAD

Molecular analysis

Intervention Type DIAGNOSTIC_TEST

RT- PCR

Interventions

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Molecular analysis

RT- PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Jaideep Mahendra

Professor and Director of PG studies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaideep Mahendra, PhD

Role: PRINCIPAL_INVESTIGATOR

MeenakshiAmmal Dental College & Hospital

Locations

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MeenakshiAmmal Dental College and Hospital

Chennai, Tamil Nadu, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 26455385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19164811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24031529 (View on PubMed)

Other Identifiers

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FLL/IRC/01/2017

Identifier Type: OTHER

Identifier Source: secondary_id

MADC/IRB/2017/260

Identifier Type: -

Identifier Source: org_study_id

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