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

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ClinicalTrials.gov Identifier: NCT04127474
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

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
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


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Study Type : Observational
Estimated 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 : October 14, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : November 20, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127474


Contacts
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Contact: Jaideep Mahendra, MDS, PhD 9444963973 jaideep_m_23@yahoo.co.in
Contact: Sruthi Srinivasan, BDS 9962152960 sruthi22596@gmail.com

Locations
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India
Meenakshi Ammal Dental College Recruiting
Chennai, Tamil Nadu, India, 600095
Contact: Jaideep Mahendra, MDS, PhD    9444963973    jaideep_m_23@yahoo.co.in   
Contact: Sruthi Srinivasan, BDS    9962152960    sruthi22596@gmail.com   
Sub-Investigator: Sruthi Srinivasan, BDS         
Principal Investigator: Jaideep Mahendra, MDS, PhD         
Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Study Director: Jaideep Mahendra, MDS, PhD Meenakshi Ammal Dental College

Publications:
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Responsible Party: Dr.Jaideep Mahendra, Professor, PhD guide, Director of Post Graduate Studies, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT04127474     History of Changes
Other Study ID Numbers: MADC/IRB-XXIX/2019/468
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
periodontitis
saliva
trefoil factor
adrenomedullin
Coronary heart disease
Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Heart Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Adrenomedullin
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents