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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174146
• Other study ID #: leptin_visfatin_diabetes
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: June 23, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?

2. Does their level change after periodontal therapy?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 54 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• non-surgical periodontal therapy
supra and subgingival debridement

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Bozkurt FY, Yetkin Ay Z, Sütçü 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. — View Citation

Johnson RB, Serio FG. Leptin within healthy and diseased human gingiva. J Periodontol. 2001 Sep;72(9):1254-7. — View 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. Epub 2007 Apr 23. — View 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. — View 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. E — View 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/j — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	3 months	No
Primary	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..	3 months	No
Secondary	pocket depth	estimation of pocket depth in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.	3 months	No
Secondary	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.	3 months	No