Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Chronic Periodontitis and Diabetic Subjects

Periodontal Diseases Clinical Trial

Official title:

Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Subgingival Tissue Samples of Generalized Severe Chronic Periodontitis Patients With and Without Type II Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391349
• Other study ID #: MADC/IRB-IX/2016/151
• Status: Completed
• Phase: N/A
• First received: December 21, 2017
• Last updated: December 29, 2017
• Start date: October 20, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2017
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.The demographic and the periodontal parameters were assessed and the correlated with the quantification of the proteins. The mRNA expression was analyzed with RT-PCR and the quantification of protein was done using ELISA.

Description:

The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.A total of 70 subjects with generalized severe chronic periodontitis were selected and divided into two groups. Group I comprised of 35 subjects who were diagnosed with generalized severe chronic periodontitis without any systemic conditions. Group II comprised of generalized severe 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 tissue samples were collected from both the groups from the periodontal surgical site. The collected samples were subjected to further molecular analysis for the mRNA expression of L-plastin, lipocalin and adiponectin using RT-PCR and for their protein quantification using ELISA.The elevated levels of mRNA expression and elevated quantification of L-plastin and Lipocalin proteins in the subgingival tissue samples of generalized severe chronic periodontitis subjects with diabetes denoted the localized involvement of these molecules in the pathogenesis of both periodontitis and type II diabetes mellitus. Since adiponectin was reduced in periodontitis patients with type II diabetes mellitus, it can be used as an anti-inflammatory and anti-diabetic biomarker for the early identification of patients at risk for diabetes mellitus and periodontitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2017
• Est. primary completion date: July 22, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients willing to participate in the study.

2. Male patients within the age group 35 to 60 years.

3. Patients having = 10 natural teeth.

4. No history of long term antibiotic use in the past 6 months and no history of diabetes mellitus.

For Group I:

• Generalized severe chronic periodontitis subjects (30% or more sites with clinical attachment loss (CAL) = 5mm) without type II diabetes mellitus.

For Group II:

• Generalized severe chronic periodontitis subjects (30% or more sites with clinical attachment loss (CAL) = 5mm) diagnosed with type II diabetes mellitus (HbA1C levels =7%) for the past 5 years and is under oral medication.

Exclusion Criteria:

1. Patients with systemic conditions, such as cardiovascular and respiratory diseases, HIV infection, immunosuppressive patients and patients under chemotherapy.

2. Smokers and other behavioral factors which may influence the study.

3. Patients who had undergone periodontal therapy within the previous 6 months.

4. Female patients (due to hormonal changes and pregnancy which may alter the oral flora).

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & Publications (1)

Öztürk VÖ, Emingil G, Osterwalder V, Bostanci N. The actin-bundling protein L-plastin: a novel local inflammatory marker associated with periodontitis. J Periodontal Res. 2015 Jun;50(3):337-46. doi: 10.1111/jre.12212. Epub 2014 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRNA expression of L-plastin,lipocalin and adiponection	mRNA expression of L-plastin,lipocalin and adiponectin using Real Time PCR	9 months
Secondary	Quantify the levels of L-plastin, lipocalin and adiponectin	Quantify levels of L-plastin, lipocalin and adiponectin using ELISA.	9 months