Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

NCT ID: NCT03727035

Last Updated: 2019-10-18

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

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-10

Study Completion Date

2019-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Periodontal Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Group I

Group I :40 Generalized chronic periodontitis subjects without type II diabetes mellitus

No interventions assigned to this group

Group II

Group II: 40 Generalized chronic periodontitis subjects diagnosed with type II diabetes mellitus

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 (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).
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 and PhD guide

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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Jaideep Mahendra

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

Daliah Ruth, BDS

Role: CONTACT

9789772881

Facility Contacts

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Jaideep Mahendra, MDS;PhD

Role: primary

9444963973 ext. 9444963973

Daliah Ruth, BDS

Role: backup

9789772881

References

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Detzen L, Chen SCY, Cheng B, Papapanou PN, Lalla E. Increased levels of soluble CD163 in periodontitis patients. J Clin Periodontol. 2017 Jun;44(6):585-590. doi: 10.1111/jcpe.12731. Epub 2017 May 16.

Reference Type BACKGROUND
PMID: 28419494 (View on PubMed)

Other Identifiers

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MADC/IRB-XV/2017/302

Identifier Type: -

Identifier Source: org_study_id

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