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Chronic PeriodontitisNCT02596581

Chemerin and IL-6 Levels in Diabetes and Periodontitis

A study testing non-surgical periodontal treatment in people with Chronic Periodontitis and Diabetes Mellitus, run by Bulent Ecevit University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis, Diabetes Mellitus
What is being tested?
non-surgical periodontal treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Jul 2014to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official title: Association of Gingival Crevicular Fluid Chemerin and IL-6 Levels in Chronic Periodontitis With and Without Type 2 Diabetes Mellitus After Non-Surgical Periodontal Therapy

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

Being tested
non-surgical periodontal treatment
Keywords
periodontitis, diabetes mellitus, chemerin, interleukin-6
Medical subject headings
Chronic Periodontitis, Diabetes Mellitus, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-surgical periodontal treatmentOther

    scaling and root planing were performed

Study groups in NCT02596581
Study groupRoleWhat they receive
diabetics with periodontally healthy groupNo interventionControl group
systemically and periodontally healthy groupNo interventionControl group
diabetics with chronic periodontitis groupActive comparatornon-surgical periodontal treatment was performed
Receives: Other: non-surgical periodontal treatment
chronic periodontitis groupActive comparatornon-surgical periodontal treatment was performed
Receives: Other: non-surgical periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. gingival crevicular fluid chemerin level

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

    Measured: 8th weeks

Secondary outcomes (5)
  1. Interleukin-6

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

    Measured: 8th weeks

  2. gingival index

    gingiva inflammation score

    Measured: 8ths week

  3. plaque index

    oral hygiene score

    Measured: 8ths week

  4. bleeding on probing

    deemed positive if it occurred within 15 seconds after probing

    Measured: 8th weeks

  5. clinical attachment level

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

    Measured: 8th weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionMay 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02596581
Sponsor's protocol ID
2014-116-17-06
Status last verified
Nov 2015
First submitted
2 Nov 2015
Last updated
4 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing non-surgical periodontal treatment in people with Chronic Periodontitis and Diabetes Mellitus, run by Bulent Ecevit University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gingival crevicular fluid chemerin level (time frame: 8th weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.

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