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CompletedNCT02596581Updated Nov 4, 2015

Chemerin and IL-6 Levels in Diabetes and Periodontitis

An interventional study of non-surgical periodontal treatment in Chronic Periodontitis and Diabetes Mellitus, sponsored by Bulent Ecevit University. Completed. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-04.

Sponsored by Bulent Ecevit University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
35 Years to 60 Years
Sex
All
01

Study summary

The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the GCF chemerin levels.

Read the detailed description

Adipose tissue is an active endocrine organ that secretes several inflammatory cytokines, namely, adipokines, which interfere with insulin sensitivity, with glucose and lipid metabolism, and with the inflammatory process.Chemerin, a more recently identified adipose tissue specific adipokine, has a crucial role in adipocyte differentiation and development, as well as in glucose, lipid metabolism and inflammation. Experimental data supports both pro- and anti-inflammatory roles for chemerin in immune cells. Therefore, it is not clear whether chemerin contributes more to the progression of inflammation or the resolution.The present investigation has been devoted to elucidate the role of chemerin in the pathogenesis that might link between DM and periodontal disease. We hypothesize that chemerin may hold value as an inflammatory mediator in CP patients with and without T2DM and non-surgical periodontal treatment could have a beneficial influence on the levels of chemerin.

The aim of this study were:

  1. to determine the role of chemerin in the pathogenesis of periodontal disease and DM via comparing with GCF levels of IL-6, which has a known proinflammatory effect in periodontal disease and DM
  2. to evaluate the effect of non-surgical periodontal treatment on GCF chemerin levels in periodontitis patients with and without T2DM.

The study included eighty subjects: 20 subjects with systemically and periodontally healthy (CTRL group), 20 patients with T2DM and periodontally healthy (DM-CTRL group), 20 patients with systemically healthy and CP (CP group), 20 patients with CP and T2DM (DM-CP group). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed at baseline and 6 weeks after periodontal therapy. Chemerin and interleukin-6 (IL-6) levels were measured by enzyme-linked immunosorbent assay, and their relative ratios were calculated.

Subjects were clinically evaluated using the following parameters; plaque index (PI), gingival index (GI) , PD, clinical attachment level (CAL) and BOP (deemed positive if it occurred within 15 seconds after probing). Clinical measurements were recorded by one calibrated examiner at six sites per tooth from the full-mouth teeth excluding third molars using with a Williams periodontal probe (Nordent Manufacturing Inc., ElkGrove Village, IL, USA) calibrated in millimeters. Anthropometric measurements included weight (kg) and height (m) of the subjects to calculate the BMI ( weight divided by the square of height, kg/m2 ).

All clinical and radiological examinations, sampling site selections were performed by one examiner and the samples were collected on the day after clinical examination of patients. This was to prevent contamination of GCF with blood associated with the probing of inflamed sites. The deepest two pocket sites of single-rooted teeth were selected for the collection of GCF in both periodontitis groups, and also two pocket sites with an absence of inflammation were sampled to ensure the collection of an adequate amount of GCF in control groups. In patients from CP and DM-CP groups, sites showing greatest PD when measured with a periodontal probes and signs of inflammation, along with radiographic conformation of bone loss were sampled. GCF samples were collected at baseline and after 8 weeks from baseline sampling in both periodontitis groups, and only at baseline in control groups. To avoid salivary contamination, the sites to be sampled were rinsed with water, isolated by cotton rolls and gently air dried. Paper strips (Periopaper; Oraflow Inc.,Smithtown, NY, USA) were gently inserted 1-2 mm into the sulcus/pocket for 30 seconds. Care was taken to avoid mechanical injury of the gingival tissues. All samples containing blood and saliva were discarded. The two strips from two sites of each individual were placed into coded sealed plastic eppendorf tubes and pooled before freezing at -80 degree

02

Conditions studied

  • Chronic Periodontitis
  • Diabetes Mellitus

Keywords

  • periodontitis
  • diabetes mellitus
  • chemerin
  • interleukin-6
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 80 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Bulent Ecevit University is the lead sponsor of 45 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diabetic subjects should have T2DM and had no any known systemic diseases other than T2DM
  • Subjects who had HbA1c levels \< 8% and ≥ 6.5% (well and moderate control)
  • Chronic periodontitis patients had radiographic evidence of bone loss and attachment loss with a minimum of 6 teeth having pocket probing depth (PD) ≥ 5mm in at least 2 different quadrants
  • Control groups were designed as healthy if the full-mouth probing depth (PD) was ≤3mm and bleeding on probing (BOP) score \< %15 at examination and they had no radiographic evidence of alveolar bone loss.

Exclusion criteria

Exclusion Criteria:

  • Presence of other systemic disorders that could influence the course of periodontal disease; pregnancy, lactation, current and former use of tobacco;
  • Administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months;
  • Need for antibiotic prophylaxis for dental treatment and having received non-surgical periodontal treatment within the past 6 months or surgical periodontal treatment within the past 12 months.
  • Subjects who had body mass index (BMI) >24.9 kg /m2
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    diabetics with periodontally healthy group

    Control group

  • No intervention
    systemically and periodontally healthy group

    Control group

  • Active comparator
    diabetics with chronic periodontitis group

    non-surgical periodontal treatment was performed

    Other: non-surgical periodontal treatment

  • Active comparator
    chronic periodontitis group

    non-surgical periodontal treatment was performed

    Other: non-surgical periodontal treatment

Interventions

  • Othernon-surgical periodontal treatment

    scaling and root planing were performed

06

What researchers measure

Primary outcomes

  1. gingival crevicular fluid chemerin level

    gingival crevicular fluid chemerin levels change from baseline to at 8th weeks

    Time frame: 8th weeks

Secondary outcomes

  1. Interleukin-6

    change of gingival crevicular fluid IL-6 levels from baseline at 8th weeks

    Time frame: 8th weeks

  2. gingival index

    gingiva inflammation score

    Time frame: 8ths week

  3. plaque index

    oral hygiene score

    Time frame: 8ths week

  4. bleeding on probing

    deemed positive if it occurred within 15 seconds after probing

    Time frame: 8th weeks

  5. clinical attachment level

    distance between the cemento-enamel junction to the deepest point of periodontal pocket

    Time frame: 8th weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02596581
Lead sponsor
Bulent Ecevit University
Responsible party
Seyma Bozkurt Doğan (Asisstant Proffessor, Bulent Ecevit University, Bulent Ecevit University) — Principal investigator
First posted
Nov 4, 2015
Start date
Jul 2014
Primary completion
May 2015
Completion
Oct 2015
Last update
Nov 4, 2015

Study contacts

Umut Ballı, Phd, DDS
principal investigator · Bülent Ecevit University Faculty of Dentistry
Figen Öngöz Dede, Phd, DDS
principal investigator · Bülent Ecevit University Faculty of Dentistry
Şeyma Bozkurt Doğan, Phd, DDS
study chair · Bülent Ecevit University Faculty of Dentistry
Erdim Sertoğlu, MD, DDS
principal investigator · Elazig Military Hospital, Department of Medical Biochemistry, Elazığ, Turke

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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