Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

NCT03727035 | Unknown

• 1 other identifier: MADC/IRB-XV/2017/302
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

CD163, Chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• Expression of CD163 gene

  Expression of CD163 gene using RT-PCR

  12 months

Secondary Outcomes (1)

• Quantify the levels of CD163

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients willing to participate in the study.
• Patients within the age group of 30-65 years (both male and female)
• Patients should have ≥ 10 natural teeth.
• Criteria for selection of generalized chronic periodontitis:
• Patients having 30% or more sites with clinical attachment loss(CAL) ≥ 5mm.
• Criteria for selection of type II diabetes mellitus:
• Patients having HbA1C \<7

You may not qualify if:

• 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.
• Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
• Current smokers, individuals who quit smoking less than 6 months.
• Patients who had undergone periodontal therapy within the previous 6 months.
• Pregnant women (which may alter the oral flora).

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Jaideep Mahendra

Chennai, Tamil Nadu, 600095, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 28419494 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaideep Mahendra, MDS,PhD

  Meenakshi Ammal Dental College

  STUDY DIRECTOR

Central Study Contacts

Jaideep Mahendra, MDS;PhD

CONTACT

9444963973; jaideep_m_23@yahoo.co.in

Daliah Ruth, BDS

CONTACT

9789772881; daliah02ruth@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and PhD guide

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: February 10, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 15, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)