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

NCT02174146 | Completed DMC

• 1 other identifier: leptin_visfatin_diabetes
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Periodontitis; Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• pocket depth

  3 months

• clinical attachment level

  3 months

Study Arms (1)

non-surgical therapy

OTHER

non-surgical periodontal therapy with ultrasonic scalers and periodontal curettes

Procedure: non-surgical periodontal therapy

Interventions

non-surgical periodontal therapy PROCEDURE

supra and subgingival debridement

Also known as: scaling and root planing

non-surgical therapy

Eligibility Criteria

• Age: 35 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine

Cairo, Egypt

Location

Related Publications (7)

• 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.

  PMID: 21966944 RESULT

• 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.

  PMID: 21309715 RESULT

• 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.

  PMID: 22684235 RESULT

• 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.

  PMID: 17559625 RESULT

• 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.

  PMID: 17451417 RESULT

• 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.

  PMID: 11577959 RESULT

• 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.

  PMID: 16584344 RESULT

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Noha Ghallab, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of periodontology, faculty of oral and dental medicine

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 25, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

EG (1)