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Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

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ClinicalTrials.gov Identifier: NCT03727035
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Brief Summary:
The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. The CD163 gene expression was analyzed with RT-PCR and the quantification of CD163 will be done using ELISA.

Condition or disease
Periodontal Diseases

Detailed Description:
The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. A total of 80 subjects with generalized chronic periodontitis were selected and divided into two groups. Group I comprised of 40 subjects who were diagnosed with generalized chronic periodontitis without any systemic conditions. Group II comprised of 40 generalized chronic periodontitis patients with type II diabetes mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachment level were recorded. Subgingival plaque samples were collected from both the groups.The collected samples were subjected to further molecular analysis for the CD163 expression using RT-PCR and for the CD163 quantification using ELISA. The elevated levels of CD163 in the subgingival plaque samples of generalized chronic periodontitis subjects with diabetes is expected and the early identification of patients at risk for diabetes mellitus and periodontitis.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Other
Official Title: Quantification of CD163 Inflammatory Biomarker in Subgingival Plaque Samples of Generalized Chronic Periodontitis With or Without Type II Diabetes Mellitus
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Group I
Group I :40 Generalized chronic periodontitis subjects without type II diabetes mellitus
Group II
Group II: 40 Generalized chronic periodontitis subjects diagnosed with type II diabetes mellitus



Primary Outcome Measures :
  1. Expression of CD163 gene [ Time Frame: 12 months ]
    Expression of CD163 gene using RT-PCR


Secondary Outcome Measures :
  1. Quantify the levels of CD163 [ Time Frame: 12 months ]
    Quantify the levels of CD163 using ELISA



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
Sampling Method:   Non-Probability Sample
Study Population
All patients within the age group of 35-60 years. The subjects were from the South Indian population.
Criteria

Inclusion Criteria:

  1. Patients willing to participate in the study.
  2. Patients within the age group of 30-65 years (both male and female)
  3. Patients should have ≥ 10 natural teeth.
  4. Criteria for selection of generalized chronic periodontitis:

    • Patients having 30% or more sites with clinical attachment loss(CAL) ≥ 5mm.
  5. Criteria for selection of type II diabetes mellitus:

    • Patients having HbA1C <7

Exclusion Criteria:

  1. Patients with systemic conditions such as respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
  2. Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
  3. Current smokers, individuals who quit smoking less than 6 months.
  4. Patients who had undergone periodontal therapy within the previous 6 months.
  5. Pregnant women (which 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): NCT03727035


Contacts
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Contact: Jaideep Mahendra, MDS;PhD 9444963973 jaideep_m_23@yahoo.co.in
Contact: Daliah Ruth, BDS 9789772881 daliah02ruth@gmail.com

Locations
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India
Jaideep Mahendra Recruiting
Chennai, Tamilnadu, India, 600095
Contact: Jaideep Mahendra, MDS;PhD    9444963973 ext 9444963973    jaideep_m_23@yahoo.co.in   
Contact: Daliah Ruth, BDS    9789772881    daliah02ruth@gmail.com   
Principal Investigator: Daliah Ruth, BDS         
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 and PhD guide, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT03727035     History of Changes
Other Study ID Numbers: MADC/IRB-XV/2017/302
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: October 18, 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:
CD163, Chronic periodontitis
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases