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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

All male 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. 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).

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Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group I; GROUP I: 35 generalized severe chronic periodontitis subjects without type II diabetes mellitus and systemically healthy.
Group II; GROUP II: 35 generalized severe chronic periodontitis subjects diagnosed with type II diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRNA expression of L-plastin,lipocalin and adiponection	mRNA expression of L-plastin,lipocalin and adiponectin using Real Time PCR	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the levels of L-plastin, lipocalin and adiponectin	Quantify levels of L-plastin, lipocalin and adiponectin using ELISA.	9 months

Collaborators and Investigators

• Sponsor: Meenakshi Ammal Dental College and Hospital
• Investigators: Study Director: Jaideep Mahendra, MDS,PhD, Meenakshi Ammal Dental College

Publications and helpful links

General Publications

• Ozturk VO, 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): July 22, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: proteomes, chronic periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: MADC/IRB-IX/2016/151

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