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

Primary Purpose

Chronic Periodontitis, Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

non-surgical periodontal therapy

About this trial

This is an interventional diagnostic trial for Chronic Periodontitis focused on measuring leptin, visfatin, chronic periodontitis, diabetes mellitus, non-surgical periodontal therapy

Eligibility Criteria

35 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty of oral and dental medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

non-surgical therapy

Arm Description

non-surgical periodontal therapy with ultrasonic scalers and periodontal curettes

Outcomes

Primary Outcome Measures

visfatin levels in gingival tissues

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..

leptin levels in gingival tissue

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..

Secondary Outcome Measures

pocket depth

estimation of pocket depth in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.

clinical attachment level

estimation of clinical attachment level in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.

Full Information

NCT ID

NCT02174146

First Posted

June 23, 2014

Last Updated

June 23, 2014

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02174146

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis, Type 2 Diabetes Mellitus

Keywords

leptin, visfatin, chronic periodontitis, diabetes mellitus, non-surgical periodontal therapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

non-surgical therapy

Arm Type

Other

Arm Description

non-surgical periodontal therapy with ultrasonic scalers and periodontal curettes

Intervention Type

Procedure

Intervention Name(s)

non-surgical periodontal therapy

Other Intervention Name(s)

scaling and root planing

Intervention Description

supra and subgingival debridement

Primary Outcome Measure Information:

Title

visfatin levels in gingival tissues

Description

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..

Time Frame

3 months

Title

leptin levels in gingival tissue

Description

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..

Time Frame

3 months

Secondary Outcome Measure Information:

Title

pocket depth

Description

estimation of pocket depth in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.

Time Frame

3 months

Title

clinical attachment level

Description

estimation of clinical attachment level in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

54 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noha Ghallab, M.D.

Organizational Affiliation

Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of oral and dental medicine

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

21966944

Citation

Pradeep AR, Raghavendra NM, Sharma A, Patel SP, Raju A, Kathariya R, Rao NS, Naik SB. Association of serum and crevicular visfatin levels in periodontal health and disease with type 2 diabetes mellitus. J Periodontol. 2012 May;83(5):629-34. doi: 10.1902/jop.2011.110272. Epub 2011 Oct 3.

Results Reference

result

PubMed Identifier

21309715

Citation

Pradeep AR, Raghavendra NM, Prasad MV, Kathariya R, Patel SP, Sharma A. Gingival crevicular fluid and serum visfatin concentration: their relationship in periodontal health and disease. J Periodontol. 2011 Sep;82(9):1314-9. doi: 10.1902/jop.2011.100690. Epub 2011 Feb 10.

Results Reference

result

PubMed Identifier

22684235

Citation

Raghavendra NM, Pradeep AR, Kathariya R, Sharma A, Rao NS, Naik SB. Effect of non surgical periodontal therapy on gingival crevicular fluid and serum visfatin concentration in periodontal health and disease. Dis Markers. 2012;32(6):383-8. doi: 10.3233/DMA-2012-0897.

Results Reference

result

PubMed Identifier

17559625

Citation

Karthikeyan BV, Pradeep AR. Leptin levels in gingival crevicular fluid in periodontal health and disease. J Periodontal Res. 2007 Aug;42(4):300-4. doi: 10.1111/j.1600-0765.2006.00948.x.

Results Reference

result

PubMed Identifier

17451417

Citation

Karthikeyan BV, Pradeep AR. Gingival crevicular fluid and serum leptin: their relationship to periodontal health and disease. J Clin Periodontol. 2007 Jun;34(6):467-72. doi: 10.1111/j.1600-051X.2007.01078.x. Epub 2007 Apr 23.

Results Reference

result

PubMed Identifier

11577959

Citation

Johnson RB, Serio FG. Leptin within healthy and diseased human gingiva. J Periodontol. 2001 Sep;72(9):1254-7. doi: 10.1902/jop.2000.72.9.1254.

Results Reference

result

PubMed Identifier

16584344

Citation

Bozkurt FY, Yetkin Ay Z, Sutcu R, Delibas N, Demirel R. Gingival crevicular fluid leptin levels in periodontitis patients with long-term and heavy smoking. J Periodontol. 2006 Apr;77(4):634-40. doi: 10.1902/jop.2006.050277.

Results Reference

result

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

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