Expression of Trefoil Factors and Adrenomedullin in Subjects With Chronic Periodontitis and Coronary Heart Disease
NCT ID: NCT04127474
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2019-10-14
2021-11-20
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Group I
25 Generalized chronic periodontitis subjects without coronary heart disease.
No interventions assigned to this group
Group II
25 Generalized chronic periodontitis subjects diagnosed with coronary heart disease.
No interventions assigned to this group
Group III
25 Periodontally healthy subjects diagnosed with coronary heart disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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)
30 Years
65 Years
ALL
Yes
Sponsors
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Meenakshi Ammal Dental College and Hospital
OTHER
Responsible Party
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Dr.Jaideep Mahendra
Professor, PhD guide, Director of Post Graduate Studies
Principal Investigators
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Jaideep Mahendra, MDS, PhD
Role: STUDY_DIRECTOR
Meenakshi Ammal Dental College
Locations
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Meenakshi Ammal Dental College
Chennai, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MADC/IRB-XXIX/2019/468
Identifier Type: -
Identifier Source: org_study_id
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