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

• Conditions: Periodontitis; Coronary Artery Disease
• Interventions: Diagnostic Test: Molecular analysis

• Registration Number: NCT04172870
• Lead Sponsor: Meenakshi Ammal Dental College and Hospital

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 ,

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MeenakshiAmmal Dental College and Hospital; 🇮🇳 Chennai, TamilNadu, India