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

M

Meenakshi Ammal Dental College and Hospital

Status

Unknown

Conditions

Coronary Artery Disease
Periodontitis

Treatments

Diagnostic Test: Molecular analysis

Study type

Observational

Funder types

Other

Identifiers

NCT04172870
MADC/IRB/2017/260
FLL/IRC/01/2017 (Other Identifier)

Details and patient eligibility

About

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).

Full 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 ,

Enrollment

240 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

240 participants in 4 patient groups

Group I
Description:
Healthy group ( No generalised periodontitis and no CAD)
Treatment:
Diagnostic Test: Molecular analysis
Group II
Description:
Generalised periodontitis patients without CAD
Treatment:
Diagnostic Test: Molecular analysis
Group III
Description:
CAD patients without generalised periodontitis
Treatment:
Diagnostic Test: Molecular analysis
Group IV
Description:
Generalised periodontitis with CAD
Treatment:
Diagnostic Test: Molecular analysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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