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

February 19, 2020 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • TamilNadu
      • Chennai, TamilNadu, India, 600095
        • MeenakshiAmmal Dental College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Indian Population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meenakshi Ammal Dental College and Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADC/IRB/2017/260
  • FLL/IRC/01/2017 (Other Identifier: Frontier Lifeline Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Perio-Continuum link could be shared through publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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