Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03727035
• Other study ID #: MADC/IRB-XV/2017/302
• Status: Recruiting
• Start date: February 10, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: October 2019
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: Jaideep Mahendra, MDS;PhD
• Phone: 9444963973
• Email: jaideep_m_23[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 15, 2019
• Est. primary completion date: November 30, 2019
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Diseases
• Periodontitis

Locations

Country	Name	City	State
India	Jaideep Mahendra	Chennai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of CD163 gene	Expression of CD163 gene using RT-PCR	12 months
Secondary	Quantify the levels of CD163	Quantify the levels of CD163 using ELISA	12 months