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
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
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
NCT ID
NCT02544347
First Posted
September 7, 2015
Last Updated
November 2, 2015
Sponsor
Bulent Ecevit University
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
Learn more about this trial
Gingival Crevicular Fluid Vaspin and Omentin Levels in Type 2 Diabetic Patients With Chronic Periodontitis
We'll reach out to this number within 24 hrs