Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

October 16, 2019 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Quantification of CD163 Inflammatory Biomarker in Subgingival Plaque Samples of Generalized Chronic Periodontitis With or Without Type II Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600095
        • Recruiting
        • Jaideep Mahendra
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daliah Ruth, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Expression of CD163 gene
Time Frame: 12 months
Expression of CD163 gene using RT-PCR
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantify the levels of CD163
Time Frame: 12 months
Quantify the levels of CD163 using ELISA
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meenakshi Ammal Dental College and Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jaideep Mahendra, MDS,PhD, Meenakshi Ammal Dental College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MADC/IRB-XV/2017/302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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