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

Primary Purpose

Chronic Periodontitis, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gingival crevicular fluid
non-surgical periodontal treatment
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring vaspin, omentin, diabetes mellitus, chronic periodontitis, tumor-necrosis factor alfa, gingival crevicular fluid

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    diabetes mellitus group

    Control group

    diabetics with chronic periodontitis group

    chronic periodontitis group

    Arm Description

    gingival crevicular fluid was collected

    gingival crevicular fluid was collected

    non-surgical periodontal treatment was completed and gingival crevicular fluid was collected

    non-surgical periodontal treatment was completed and gingival crevicular fluid was collected

    Outcomes

    Primary Outcome Measures

    vaspin levels
    gingival crevicular fluid vaspin levels change from baseline at 8th weeks
    omentin levels
    gingival crevicular fluid omentin levels change from baseline at 8th weeks

    Secondary Outcome Measures

    tumor necrosis factor alfa
    change of gingival crevicular fluid tumor necrosis factor alfa levels from baseline at 8th weeks
    gingival index
    gingiva inflammation score
    plaque index
    oral hygen score
    bleeding on probing
    deemed positive if it occurred within 15 seconds after probing
    clinical attachment level
    distance between the cemento-enamel junction to the deepest point of periodontal pocket

    Full Information

    First Posted
    September 7, 2015
    Last Updated
    November 2, 2015
    Sponsor
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02544347
    Brief Title
    Gingival Crevicular Fluid Vaspin and Omentin Levels in Type 2 Diabetic Patients With Chronic Periodontitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bulent Ecevit University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Diabetes Mellitus
    Keywords
    vaspin, omentin, diabetes mellitus, chronic periodontitis, tumor-necrosis factor alfa, gingival crevicular fluid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    diabetes mellitus group
    Arm Type
    Other
    Arm Description
    gingival crevicular fluid was collected
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    gingival crevicular fluid was collected
    Arm Title
    diabetics with chronic periodontitis group
    Arm Type
    Other
    Arm Description
    non-surgical periodontal treatment was completed and gingival crevicular fluid was collected
    Arm Title
    chronic periodontitis group
    Arm Type
    Other
    Arm Description
    non-surgical periodontal treatment was completed and gingival crevicular fluid was collected
    Intervention Type
    Other
    Intervention Name(s)
    gingival crevicular fluid
    Intervention Description
    gingival crevicular fluid was collected
    Intervention Type
    Other
    Intervention Name(s)
    non-surgical periodontal treatment
    Intervention Description
    scaling and root planing were performed
    Primary Outcome Measure Information:
    Title
    vaspin levels
    Description
    gingival crevicular fluid vaspin levels change from baseline at 8th weeks
    Time Frame
    8th weeks
    Title
    omentin levels
    Description
    gingival crevicular fluid omentin levels change from baseline at 8th weeks
    Time Frame
    8th weeks
    Secondary Outcome Measure Information:
    Title
    tumor necrosis factor alfa
    Description
    change of gingival crevicular fluid tumor necrosis factor alfa levels from baseline at 8th weeks
    Time Frame
    8th weeks
    Title
    gingival index
    Description
    gingiva inflammation score
    Time Frame
    8ths week
    Title
    plaque index
    Description
    oral hygen score
    Time Frame
    8th weeks
    Title
    bleeding on probing
    Description
    deemed positive if it occurred within 15 seconds after probing
    Time Frame
    8th weeks
    Title
    clinical attachment level
    Description
    distance between the cemento-enamel junction to the deepest point of periodontal pocket
    Time Frame
    8th weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Umut Ballı, DDS
    Organizational Affiliation
    Bülent Ecevit University Faculty of Dentistry
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Şeyma Bozkurt Doğan, DDS
    Organizational Affiliation
    Bülent Ecevit University Faculty of Dentistry
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Figen Öngöz Dede, DDS
    Organizational Affiliation
    Bülent Ecevit University Faculty of Dentistry
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Erdim Sertoğlu, MD, DDS
    Organizational Affiliation
    Gülhane Military Medical Academy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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