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

Overview

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.

Full Title of Study: “Expression of Trefoil Factors 2 and 3 and Adrenomedullin in Unstimulated Saliva Samples of Chronic Periodontitis Subjects With and Without Coronary Heart Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 20, 2020

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Patients willing to participate in the study. 2. Patients within the age group of 30-65 years. 3. Patients should have ≥ 20 remaining natural teeth. 4. 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. 5. 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. 6. 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:

1. 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. 2. For Group I, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded. 3. Current smokers and individuals who quit smoking less than 6 months. 4. Patients who have undergone periodontal therapy within the previous 6 months. 5. Pregnant women (pregnancy may alter the oral flora)

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Meenakshi Ammal Dental College and Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr.Jaideep Mahendra, Professor, PhD guide, Director of Post Graduate Studies – Meenakshi Ammal Dental College and Hospital
  • Overall Official(s)
    • Jaideep Mahendra, MDS, PhD, Study Director, Meenakshi Ammal Dental College
  • Overall Contact(s)
    • Jaideep Mahendra, MDS, PhD, 9444963973, jaideep_m_23@yahoo.co.in

References

Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.

Suchetha A, Garg A, Lakshmi P, Bhat D, Sapna N, Apoorva SM. Adrenomedullin, periodontitis, diabetes-unraveling the equivocal relationship: A clinicobiochemical cross-sectional study. Contemp Clin Dent. 2013 Oct;4(4):454-9. doi: 10.4103/0976-237X.123040.

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