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CompletedNCT02174146Updated Jun 25, 2014

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

An interventional study of non-surgical periodontal therapy in Chronic Periodontitis and Type 2 Diabetes Mellitus, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 35 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-25.

Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
35 Years to 54 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Periodontitis
  • Type 2 Diabetes Mellitus

Keywords

  • leptin
  • visfatin
  • chronic periodontitis
  • diabetes mellitus
  • non-surgical periodontal therapy
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Other
    non-surgical therapy

    non-surgical periodontal therapy with ultrasonic scalers and periodontal curettes

    Procedure: non-surgical periodontal therapy

Interventions

  • Procedurenon-surgical periodontal therapy

    supra and subgingival debridement

    Also known as: scaling and root planing

06

What researchers measure

Primary outcomes

  1. 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..

    Time frame: 3 months

  2. 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..

    Time frame: 3 months

Secondary outcomes

  1. pocket depth

    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

  2. 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.

    Time frame: 3 months

07

Study locations

1 site
  • Faculty of oral and dental medicine
    Cairo, Egypt
08

References and documents

Publications

  • 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. PubMed 21966944 ↗
  • 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. PubMed 21309715 ↗
  • 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. PubMed 22684235 ↗
  • 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. PubMed 17559625 ↗
  • 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. PubMed 17451417 ↗
  • 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. PubMed 11577959 ↗
  • 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. PubMed 16584344 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02174146
Lead sponsor
Cairo University
Responsible party
Noha Ayman Ghallab (Associate Professor of periodontology, faculty of oral and dental medicine, Cairo University) — Principal investigator
First posted
Jun 25, 2014
Start date
Sep 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jun 25, 2014

Study contacts

Noha Ghallab, M.D.
principal investigator · Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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