Clinical trial NCT02174146: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Type 2 Diabetes Mellitus
Keywords: leptin
visfatin
chronic periodontitis
diabetes mellitus
non-surgical periodontal therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?
2. 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.

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.

Primary outcomes:
measure: visfatin levels in gingival tissues
timeFrame: 3 months
measure: leptin levels in gingival tissue
timeFrame: 3 months
Secondary outcomes:
measure: pocket depth
timeFrame: 3 months
measure: clinical attachment level
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine
Study officials:
affiliation: Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.
name: Noha Ghallab, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.