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Gingival Crevicular Fluid Vaspin and Omentin Levels in Type 2 Diabetic Patients With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02544347
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Seyma Bozkurt Doğan, Bulent Ecevit University

Brief Summary:
The aim of the present study were 1) to determine the role of these adipokines in the pathogenesis of periodontal disease, inflammation and tissue destruction comparing with gingival crevicular fluid (GCF) levels of TNF-α, which has a known pro-inflammatory effect in periodontal disease, 2) to investigate the effect of non-surgical periodontal treatment on GCF vaspin and omentin levels in type 2 diabetic (T2DM) patients with Chronic Periodontitis (CP).

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Diabetes Mellitus Other: gingival crevicular fluid Other: non-surgical periodontal treatment Not Applicable

Detailed Description:

Adipose tissue produces and releases a variety of inflammatory factors, including adipocytokines , such as adiponectin, leptin, tumor-necrosis factor alpha (TNF-α), interleukin-6 (IL-6), visfatin, vaspin and omentin.These adipokines have widespread effects on carbohydrate and lipid metabolism and appear to play an important role in the pathogenesis of insulin resistance, diabetes, inflammation, wound healing, and immune responses.Recently, studies evaluated the serum vaspin and omentin levels as inflammatory markers in T2DM patients. Based on the above mentioned studies, the present investigation has been devoted to elucidate the role of adipokines in the pathogenesis that might link DM and periodontal disease. We hypothesize that vaspin and omentin are inflammatory adipokines involved in chronic inflammation and are associated with T2DM and CP. Additionally, the evaluation of GCF vaspin and omentin levels can provide advance the biologic link between DM and periodontitis. Until now, levels of GCF vaspin and omentin in CP patients with T2DM before and after non-surgical periodontal treatment has not been explored. Hence, the aim of the present study were 1) to determine the role of these adipokines in the pathogenesis of periodontal disease, inflammation and tissue destruction comparing with GCF levels of TNF-α, which has a known pro-inflammatory effect in periodontal disease 2) to investigate the effect of non-surgical periodontal treatment on GCF vaspin and omentin levels in T2DM patients with CP.

A total of 15 T2DM patients with CP ( DM-CP group), 15 CP patients (CP group), 15 T2DM patients (DM-CTRL group) and 15 subjects with systemically and periodontally healthy control subjects (CTRL group) were included in the study. Diabetic subjects should have T2DM and had no any known systemic diseases other than T2DM. The glycemic status of patients previously diagnosed with T2DM was confirmed by their glycated haemoglobin (HbA1c) levels. Periodontal disease status was determined according to clinical and radiographic criteria by the 1999 classification of periodontal disease.

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Non-Surgical Periodontal Treatment on the Gingival Crevicular Fluid Levels of Vaspin and Omentin-1 in Type 2 Diabetic Patients With Chronic Periodontitis
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
diabetes mellitus group
gingival crevicular fluid was collected
Other: gingival crevicular fluid
gingival crevicular fluid was collected

Control group
gingival crevicular fluid was collected
Other: gingival crevicular fluid
gingival crevicular fluid was collected

diabetics with chronic periodontitis group
non-surgical periodontal treatment was completed and gingival crevicular fluid was collected
Other: gingival crevicular fluid
gingival crevicular fluid was collected

Other: non-surgical periodontal treatment
scaling and root planing were performed

chronic periodontitis group
non-surgical periodontal treatment was completed and gingival crevicular fluid was collected
Other: gingival crevicular fluid
gingival crevicular fluid was collected

Other: non-surgical periodontal treatment
scaling and root planing were performed




Primary Outcome Measures :
  1. vaspin levels [ Time Frame: 8th weeks ]
    gingival crevicular fluid vaspin levels change from baseline at 8th weeks

  2. omentin levels [ Time Frame: 8th weeks ]
    gingival crevicular fluid omentin levels change from baseline at 8th weeks


Secondary Outcome Measures :
  1. tumor necrosis factor alfa [ Time Frame: 8th weeks ]
    change of gingival crevicular fluid tumor necrosis factor alfa levels from baseline at 8th weeks

  2. gingival index [ Time Frame: 8ths week ]
    gingiva inflammation score

  3. plaque index [ Time Frame: 8th weeks ]
    oral hygen score

  4. bleeding on probing [ Time Frame: 8th weeks ]
    deemed positive if it occurred within 15 seconds after probing

  5. clinical attachment level [ Time Frame: 8th weeks ]
    distance between the cemento-enamel junction to the deepest point of periodontal pocket



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Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544347


Sponsors and Collaborators
Bulent Ecevit University
Investigators
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Principal Investigator: Umut Ballı, DDS Bülent Ecevit University Faculty of Dentistry
Study Chair: Şeyma Bozkurt Doğan, DDS Bülent Ecevit University Faculty of Dentistry
Principal Investigator: Figen Öngöz Dede, DDS Bülent Ecevit University Faculty of Dentistry
Principal Investigator: Erdim Sertoğlu, MD, DDS Gülhane Military Medical Academy

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Responsible Party: Seyma Bozkurt Doğan, Asisstant Proffessor, Bulent Ecevit University, Bulent Ecevit University
ClinicalTrials.gov Identifier: NCT02544347     History of Changes
Other Study ID Numbers: 2014-116-17/06
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: September 2015

Keywords provided by Seyma Bozkurt Doğan, Bulent Ecevit University:
vaspin
omentin
diabetes mellitus
chronic periodontitis
tumor-necrosis factor alfa
gingival crevicular fluid

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases