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

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127474
• Other study ID #: MADC/IRB-XXIX/2019/468
• Status: Recruiting
• Start date: October 14, 2019
• Est. completion date: November 20, 2021

Study information

• Verified date: September 2020
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: Jaideep Mahendra, MDS, PhD
• Phone: 9444963973
• Email: jaideep_m_23[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 20, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Periodontitis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Periodontal Diseases
• Periodontitis

Locations

Country	Name	City	State
India	Meenakshi Ammal Dental College	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease	Expression of Trefoil factors 2 and 3 and Adrenomedullin using Enzyme Linked Immunosorbent Assay	12 months