Leptin and Visfatin in Diabetic Patients With Periodontitis Before and After Periodontal Therapy

June 23, 2014 updated by: Noha Ayman Ghallab, Cairo University

Effect of Non-surgical Periodontal Therapy on Leptin and Visfatin Expression in Gingival Tissues of Chronic Periodontitis With and Without Type 2 Diabetes Mellitus: A Study Utilizing ELISA and Real Time PCR

  1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?
  2. Does their level change after periodontal therapy?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic periodontitis only and patients with chronic periodontitis and diabetes were evaluated for levels of leptin and visfatin in the gingival tissues before and after non-surgical periodontal therapy.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Oral and Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 54 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diabetic patients having diabetes mellitus ≥5 years prior to the study.
  • chronic periodontitis with clinical attachment loss > 5 mm.
  • otherwise systemically healthy subjects.

Exclusion Criteria:

  • any known systemic diseases other than diabetes.
  • pregnancy or lactation.
  • smokers.
  • receiving periodontal treatment in the last 6 months.
  • taking any drugs or medications other than anti-diabetic drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: non-surgical therapy
non-surgical periodontal therapy with ultrasonic scalers and periodontal curettes
Procedure: non-surgical periodontal therapy
supra and subgingival debridement
Other Names:
  • scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visfatin levels in gingival tissues
Time Frame: 3 months
estimation of protein and gene expression of visfatin in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy..
3 months
leptin levels in gingival tissue
Time Frame: 3 months
estimation of protein and gene expression of leptin in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy..
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pocket depth
Time Frame: 3 months
estimation of pocket depth in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.
3 months
clinical attachment level
Time Frame: 3 months
estimation of clinical attachment level in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Noha Ghallab, M.D., Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • leptin_visfatin_diabetes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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