Clincosm LogoSign in Get a demo

Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

Sponsor
Meenakshi Ammal Dental College and Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03727035
Collaborator
(none)
80
Enrollment
1
Location
22.1
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Feb 10, 2018
    Anticipated Primary Completion Date :
    Nov 30, 2019
    Anticipated Study Completion Date :
    Dec 15, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Expression of CD163 gene [12 months]

      Expression of CD163 gene using RT-PCR

    Secondary Outcome Measures

    1. Quantify the levels of CD163 [12 months]

      Quantify the levels of CD163 using ELISA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    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.
    1. 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jaideep Mahendra Chennai Tamilnadu India 600095

    Sponsors and Collaborators

    • Meenakshi Ammal Dental College and Hospital

    Investigators

    • Study Director: Jaideep Mahendra, MDS,PhD, Meenakshi Ammal Dental College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr.Jaideep Mahendra, Professor and PhD guide, Meenakshi Ammal Dental College and Hospital
    ClinicalTrials.gov Identifier:
    NCT03727035
    Other Study ID Numbers:
    • MADC/IRB-XV/2017/302
    First Posted:
    Nov 1, 2018
    Last Update Posted:
    Oct 18, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr.Jaideep Mahendra, Professor and PhD guide, Meenakshi Ammal Dental College and Hospital
    CD163, Chronic periodontitis
    Additional relevant MeSH terms:
    Periodontitis
    Periodontal Diseases
    Chronic Periodontitis

    Study Results

    No Results Posted as of Oct 18, 2019