Clinical trial NCT03391349: Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Chronic Periodontitis and Diabetic Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: proteomes, chronic periodontitis
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 70
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: mRNA expression of L-plastin,lipocalin and adiponection
timeFrame: 9 months
Secondary outcomes:
measure: Quantify the levels of L-plastin, lipocalin and adiponectin
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Meenakshi Ammal Dental College
name: Jaideep Mahendra, MDS,PhD
role: STUDY_DIRECTOR
References:
citation: 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.