Expression of Trefoil Factors and Adrenomedullin in Subjects With Chronic Periodontitis and Coronary Heart Disease

Sponsor

Meenakshi Ammal Dental College and Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04127474

Collaborator

(none)

Enrollment

Location

25.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Periodontal Diseases

Detailed Description

A total of 75 subjects will be recruited for the study based on the power of the study.

The selected subjects will be divided into 3 groups based on inclusion and exclusion criteria.

GROUP I:25Generalized chronic periodontitis subjects without coronary heart disease.

GROUP II: 25Generalized chronic periodontitis subjects diagnosed with coronary heart disease.

GROUP III: 25Periodontally healthy subjects diagnosed with coronary heart disease.

Demographic variables, periodontal parameters and biochemical parameters will be measured in all three groups

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Expression of Trefoil Factors 2 and 3 and Adrenomedullin in Unstimulated Saliva Samples of Chronic Periodontitis Subjects With and Without Coronary Heart Disease

Actual Study Start Date :

Oct 14, 2019

Anticipated Primary Completion Date :

Dec 20, 2020

Anticipated Study Completion Date :

Nov 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group I 25 Generalized chronic periodontitis subjects without coronary heart disease.
Group II 25 Generalized chronic periodontitis subjects diagnosed with coronary heart disease.
Group III 25 Periodontally healthy subjects diagnosed with coronary heart disease.

Outcome Measures

Primary Outcome Measures

Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease [12 months]
Expression of Trefoil factors 2 and 3 and Adrenomedullin using Enzyme Linked Immunosorbent Assay

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients willing to participate in the study.
Patients within the age group of 30-65 years.
Patients should have ≥ 20 remaining natural teeth.
For Group I

• Systemically healthy, Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction.

For Group II

• Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction along with coronary heart disease.

For Group III • Periodontally healthy subjects with Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at ≤15% of tooth sites, no periodontal treatment (Scaling and root planing or periodontal surgery) within the previous 6 months and without evident clinical signs of gingival inflammation along with the presence of coronary heart disease.

Exclusion Criteria:

Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
For Group I, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
Current smokers and individuals who quit smoking less than 6 months.
Patients who have undergone periodontal therapy within the previous 6 months.
Pregnant women (pregnancy may alter the oral flora)