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

NCT03391349 | Completed

• 1 other identifier: MADC/IRB-IX/2016/151
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases

Keywords

proteomes, chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• mRNA expression of L-plastin,lipocalin and adiponection

  mRNA expression of L-plastin,lipocalin and adiponectin using Real Time PCR

  9 months

Secondary Outcomes (1)

• Quantify the levels of L-plastin, lipocalin and adiponectin

  9 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 60 Years
• Gender Eligibility Details: Only male subjects were included in the study. females were excluded as hormonal changes may alter the oral flora.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patients willing to participate in the study.
• Male patients within the age group 35 to 60 years.
• Patients having ≥ 10 natural teeth.
• 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.

You may not qualify if:

• Patients with systemic conditions, such as cardiovascular and respiratory diseases, HIV infection, immunosuppressive patients and patients under chemotherapy.
• Smokers and other behavioral factors which may influence the study.
• Patients who had undergone periodontal therapy within the previous 6 months.
• Female patients (due to hormonal changes and pregnancy which may alter the oral flora).

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Related Publications (1)

• 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.

  PMID: 25040533 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

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: December 21, 2017
• First Posted: January 5, 2018
• Study Start: October 20, 2016
• Primary Completion: July 22, 2017
• Study Completion: December 1, 2017
• Last Updated: January 5, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share