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

NCT04127474 | Unknown DMC

• 1 other identifier: MADC/IRB-XXIX/2019/468
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Periodontal Diseases

Keywords

periodontitis; saliva; trefoil factor; adrenomedullin; Coronary heart disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from 30 years to 65 years will be recruited for the study. Subjects would be categorized into the above mentioned three groups based on their medical status.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Meenakshi Ammal Dental College

Chennai, Tamil Nadu, 600095, India

RECRUITING

Related 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.

  PMID: 22181686 BACKGROUND

• 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.

  PMID: 24403788 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jaideep Mahendra, MDS, PhD

  Meenakshi Ammal Dental College

  STUDY DIRECTOR

Central Study Contacts

Jaideep Mahendra, MDS, PhD

CONTACT

9444963973; jaideep_m_23@yahoo.co.in

Sruthi Srinivasan, BDS

CONTACT

9962152960; sruthi22596@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD guide, Director of Post Graduate Studies

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 15, 2019
• Study Start: October 14, 2019
• Primary Completion: December 20, 2020
• Study Completion: November 20, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)