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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2021-11-20

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Heart Disease Periodontal Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Jaideep Mahendra

Professor, PhD guide, Director of Post Graduate Studies

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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India

Central Contacts

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Jaideep Mahendra, MDS, PhD

Role: CONTACT

9444963973

Sruthi Srinivasan, BDS

Role: CONTACT

9962152960

Facility Contacts

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Jaideep Mahendra, MDS, PhD

Role: primary

9444963973

Sruthi Srinivasan, BDS

Role: backup

9962152960

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.

Reference Type BACKGROUND
PMID: 22181686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24403788 (View on PubMed)

Other Identifiers

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MADC/IRB-XXIX/2019/468

Identifier Type: -

Identifier Source: org_study_id

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