Chronic PeriodontitisNCT02544347
Gingival Crevicular Fluid Vaspin and Omentin Levels in Type 2 Diabetic Patients With Chronic Periodontitis
A study testing gingival crevicular fluid and non-surgical periodontal treatment in people with Chronic Periodontitis and Diabetes Mellitus, run by Bulent Ecevit University.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Diabetes Mellitus
- What is being tested?
- gingival crevicular fluid and non-surgical periodontal treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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: 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
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).
Read the 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
- Conditions
- Chronic Periodontitis, Diabetes Mellitus
- Being tested
- gingival crevicular fluid, non-surgical periodontal treatment
- Keywords
- vaspin, omentin, diabetes mellitus, chronic periodontitis, tumor-necrosis factor alfa, gingival crevicular fluid
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival crevicular fluidOther
gingival crevicular fluid was collected
non-surgical periodontal treatmentOther
scaling and root planing were performed
| Study group | Role | What they receive |
|---|---|---|
| diabetes mellitus group | Other | gingival crevicular fluid was collected Receives: Other: gingival crevicular fluid |
| Control group | Other | gingival crevicular fluid was collected Receives: Other: gingival crevicular fluid |
| diabetics with chronic periodontitis group | Other | non-surgical periodontal treatment was completed and gingival crevicular fluid was collected Receives: Other: gingival crevicular fluid; Other: non-surgical periodontal treatment |
| chronic periodontitis group | Other | non-surgical periodontal treatment was completed and gingival crevicular fluid was collected Receives: Other: gingival crevicular fluid; Other: non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaspin levels
gingival crevicular fluid vaspin levels change from baseline at 8th weeks
Measured: 8th weeks
omentin levels
gingival crevicular fluid omentin levels change from baseline at 8th weeks
Measured: 8th weeks
Secondary outcomes (5)
tumor necrosis factor alfa
change of gingival crevicular fluid tumor necrosis factor alfa levels from baseline at 8th weeks
Measured: 8th weeks
gingival index
gingiva inflammation score
Measured: 8ths week
plaque index
oral hygen score
Measured: 8th weeks
bleeding on probing
deemed positive if it occurred within 15 seconds after probing
Measured: 8th weeks
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.
- First posted9 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Bozkurt Doğan, Bulent Ecevit University
- Investigators
- Umut Ballı, DDS, Principal investigator, Bülent Ecevit University Faculty of DentistryŞeyma Bozkurt Doğan, DDS, Study chair, Bülent Ecevit University Faculty of DentistryFigen Öngöz Dede, DDS, Principal investigator, Bülent Ecevit University Faculty of DentistryErdim Sertoğlu, MD, DDS, Principal investigator, Gülhane Military Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544347
- Sponsor's protocol ID
- 2014-116-17/06
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02544347
- Acronym / sponsor ID
- 2014-116-17/06
- Conditions
- Chronic Periodontitis, Diabetes Mellitus
- Keywords
- vaspin, omentin, diabetes mellitus, chronic periodontitis, tumor-necrosis factor alfa, gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diabetes mellitus group | Other | Other: gingival crevicular fluidgingival crevicular fluid was collected |
| Control group | Other | Other: gingival crevicular fluidgingival crevicular fluid was collected |
| diabetics with chronic periodontitis group | Other | Other: gingival crevicular fluid, Other: non-surgical periodontal treatmentnon-surgical periodontal treatment was completed and gingival crevicular fluid was collected |
| chronic periodontitis group | Other | Other: gingival crevicular fluid, Other: non-surgical periodontal treatmentnon-surgical periodontal treatment was completed and gingival crevicular fluid was collected |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingival crevicular fluidgingival crevicular fluid was collected | Other | Control group, chronic periodontitis group, diabetes mellitus group, diabetics with chronic periodontitis group |
| non-surgical periodontal treatmentscaling and root planing were performed | Other | chronic periodontitis group, diabetics with chronic periodontitis group |
Primary outcome
vaspin levels
Time frame: 8th weeks
gingival crevicular fluid vaspin levels change from baseline at 8th weeks
omentin levels
Time frame: 8th weeks
gingival crevicular fluid omentin levels change from baseline at 8th weeks
5 secondary outcomes
tumor necrosis factor alfa
Time frame: 8th weeks
gingival index
Time frame: 8ths week
plaque index
Time frame: 8th weeks
bleeding on probing
Time frame: 8th weeks
clinical attachment level
Time frame: 8th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Ballı, DDS principal investigator
Bülent Ecevit University Faculty of Dentistry
Şeyma Bozkurt Doğan, DDS study chair
Bülent Ecevit University Faculty of Dentistry
Figen Öngöz Dede, DDS principal investigator
Bülent Ecevit University Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing gingival crevicular fluid and 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 3 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?
vaspin levels (time frame: 8th weeks). The study lists 2 primary outcomes in all. 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 3 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.