ObesityNCT03470987
The Role of Visfatin in Obesity and Periodontal Disease
An observational study of Obesity and Periodontitis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Visfatin is an adipokine that plays an important role in immune functions as a growth factor, enzyme, and proinflammatory mediator. The investigators aimed to determine the levels of visfatin, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in gingival crevicular fluid (GCF) in both obese/non-obese… Read more about this study
- Who is it for?
- Ages 20 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Periodontitis
- What is being tested?
- Phase I Periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2013to Sep 2014
- Phase
- Observational
- 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 20 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The 195 patients diagnosed with obesity in the outpatient clinics of Endocrinology and Metabolic Diseases Department, Ataturk Hospital, Turkey, were potential candidates and were interviewed according to our case definition and invited to be included in the study. Thirty-one of 195 volunteers accepted and signed the informed study protocol and took part in the study. All individuals were thoroughly informed of the nature, potential risks, and benefits of their participation in the study before providing their informed consent. In the same period, 100 consecutive non-obese patients were screened from the Department of Periodontology, Faculty of Dentistry, Gazi University, Turkey, who were systemically healthy and fulfilled the inclusion criteria, of which 19 agreed to participate.
Who may be able to join
- having > 22 natural teeth
- no systemic diseases
- having good cooperation
- having BMI > 30
- waist circumference > 88 cm for females for obese patients
- waist circumference > 102 cm for males for obese patients
- age > 20 years
Who cannot join
- presence of localized chronic periodontitis
- received periodontal therapy/surgery in the previous 6 months
- pregnancy
- use of any hormone therapy
- history of antibiotic or anti-inflammatory drugs therapy within the previous 6 months
- current and former smoker
Show all 9Show fewer
- lactation
- presence of aggressive periodontitis
- presence of periapical pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Visfatin Levels in Gingival Crevicular Fluid as Potential Biomarker in The Relationship Between Obesity and Periodontal Disease
Visfatin is an adipokine that plays an important role in immune functions as a growth factor, enzyme, and proinflammatory mediator. The investigators aimed to determine the levels of visfatin, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in gingival crevicular fluid (GCF) in both obese/non-obese patients, with/without generalized chronic periodontitis (GCP). Patients were categorized as obese (O) (n=31) or non-obese (nO) (n=19). Groups were divided into four subgroups according to periodontal conditions: (1) periodontally healthy without obesity (nO-Ctrl); (2) GCP without obesity (nO-CP); (3) periodontally healthy with obesity (O-Ctrl); and (4) GCP with obesity (O-CP). Demographic variables and anthropometric and laboratory data were recorded. Periodontal measurements were recorded at baseline and 3rd months after either non-surgical periodontal treatment or calorie restricted diet therapy. At the same time GCF samples were taken from patients to analyze TNF-alpha, IL-6, and visfatin levels.
Read the detailed description
Overweightness and obesity are defined as the accumulation of fat in body tissues that might impair overall health. Adults are considered overweight if their body mass index (BMI, calculated as weight in kg/[height in meters]2) is ≥ 25 and obese if BMI ≥ 30 kg/m2. The prevalence of overweightness and obesity has increased worldwide during recent decades.
Obesity is usually related to a chronic low-grade systemic inflammation resulting in significant changes in the concentrations of cytokines and hormones, which subsequently leads to the development of obesity-linked disorders, including insulin resistance, type II diabetes, cardiovascular diseases, dyslipidemia, and metabolic syndrome. Since the host response is among the most crucial factors affecting the pathogenesis of periodontal disease, multiple studies have addressed the possible associations between BMI, overweightness, obesity, diabetes, the serum level of lipids, cholesterol, and periodontal breakdown, with mixed results. Many studies have demonstrated a positive association between obesity and periodontitis and suggested that obesity-related inflammation might promote periodontitis by secretion of inflammatory markers by the adipose tissue, which might subsequently increase gingival inflammation. The association between obesity and periodontal disease is based on the amassing of white adipose tissue (WAT) and increased secretion levels of adipokines from WAT.
WAT is an energy storage organ with some metabolic activities, participating in the endocrine and secretory systems. WAT secretes several immune-modulatory adipokine molecules, such as adiponectin, leptin, visfatin, resistin, chemerin, tumor necrosis factor-alpha (TNF-alpha), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It has been found that these molecules are involved in a wide range of physiologic and pathologic processes, including immunity and inflammation. Thus, cytokines and hormones released from adipose tissue might play a role in the destruction of periodontal tissue by inducing hyperinflammatory responses.
Visfatin is a multi-potential mediator that functions as a growth factor, cytokine, an enzyme with a role in energy metabolism, and as a proinflammatory mediator. It is mainly released from adipose tissue, especially from macrophages, and can also be released from lymphocytes, dendritic, muscle, and bone marrow cells. Visfatin has an important role in the regulation of the immune response. Visfatin inhibits neutrophil apoptosis during inflammation and increases TNF-alpha, IL-1β, and IL-6 levels. The expression of visfatin is increased under inflammatory conditions, such as rheumatoid arthritis, cardiovascular diseases, type-II diabetes mellitus, and periodontal disease.
Although several studies have demonstrated the relationship between periodontitis and obesity, no study has evaluated the levels of visfatin in gingival crevicular fluid (GCF) in obese individuals with periodontitis. Increased adipocytes levels, such as visfatin, cause secretion of cytokines, which are known to play an important role in periodontitis, and might trigger periodontitis formation and development.
Therefore, the main objective of this study was to analyze the levels of visfatin, IL-6, and TNF-alpha in obese and non-obese individuals, with or without generalized chronic periodontitis (GCP). Secondarily, the investigators aimed to evaluate metabolic and clinical periodontal parameters, and also clarify the relationship between these parameters and adipocytokines. The hypothesis is that adipocytokine molecules are involved in the pathogenesis of inflammatory diseases; if true, individuals who are obese with periodontitis would present increased levels of visfatin, IL-6, and TNF-alpha in their GCF.
- Conditions
- Obesity, Periodontitis
- Being tested
- Phase I Periodontal therapy, Metabolic control
- Keywords
- obesity, periodontitis, cytokines
- Medical subject headings
- Obesity, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I Periodontal therapyProcedure or surgery
Oral hygiene instuction, scaling and root planning
Metabolic controlDietary supplement
Calorie restricted diet
| Study group | Role | What they receive |
|---|---|---|
| Group 1:nO-Ctrl | Non-obese patients without generalized chronic periodontitis who were undergone Phase I periodontal therapy Receives: Procedure: Phase I Periodontal therapy | |
| Group 2:nO-CP | Non-obese patients with generalized chronic periodontitis who were undergone Phase I periodontal therapy Receives: Procedure: Phase I Periodontal therapy | |
| Group 3: O-Ctrl | Obese patients without generalized chronic periodontitis who were undergone metabolic control and Phase I periodontal therapy Receives: Procedure: Phase I Periodontal therapy; Dietary Supplement: Metabolic control | |
| Group 4: O-CP | Obese patients with generalized chronic periodontitis who were undergone metbolic control and Phase I periodontal therapy Receives: Procedure: Phase I Periodontal therapy; Dietary Supplement: Metabolic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels in Gingival crevicular fluid
Gingival crevicular fluid samples were collected at baseline and repeated at 3rd months following Phase I periodontal therapy and metabolic control.
In the periodontally healthy group, samples were obtained from maxillary anterior four teeth exhibiting probing depth < 3mm without clinical attachment level or bleeding on probing. Four sites from each tooth were used for Gingival crevicular fluid sampling.
In the generalized chronic periodontitis groups, Gingival crevicular fluid samples were collected from four teeth with bleeding on probing, probing depth≥ 5 mm, clinical attachment level≥ 5 mm, and 30% bone loss. Visfatin, TNF alpha and IL-6 levels in these fluid samples were determined using an enzyme-linked immunosorbent assay (ELISA).
Measured: Beginning of the study (baseline) and 3 months following Phase I periodontal therapy and metbolic control
Secondary outcomes (5)
Clinical attachment level
Clinical attachment level which is the position of the soft tissue in relation to the cemento-enamel junction was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Measured: Change from baseline clinical attachment level to 3rd month level
Probing depth
Probing depth was noted from all teeth, excluding third molars, on midbuccal and midlingual sites and the buccal aspects of the interproximal contact area for mesial and distal sites using a William's periodontal probe at baseline and 3 months following Phase I periodontal therapy and metabolic control
Measured: Change from baseline probing depth value at 3rd month value
Bleeding on probing
The presence of bleeding after probing was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Measured: Change from baseline bleeding on probing score to 3rd month score
Gingival index
The gingival index which is a measure of periodontal disease based on the severity and location of the lesion was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Measured: Change from baseline gingival index score to 3rd month score
Plaque index
The plaque index which is an index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Measured: Change from baseline plaque index score to 3rd month score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Cetiner, Gazi University
- Investigators
- Deniz Cetiner, Prof, Study chair, Gazi University Faculty of Dentistry Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470987
- Sponsor's protocol ID
- OBESITY
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keller A, Rohde JF, Raymond K, Heitmann BL. Association between periodontal disease and overweight and obesity: a systematic review. J Periodontol. 2015 Jun;86(6):766-76. doi: 10.1902/jop.2015.140589. Epub 2015 Feb 12.
PubMed 25672656Suvan J, D'Aiuto F, Moles DR, Petrie A, Donos N. Association between overweight/obesity and periodontitis in adults. A systematic review. Obes Rev. 2011 May;12(5):e381-404. doi: 10.1111/j.1467-789X.2010.00808.x. Epub 2011 Feb 23.
PubMed 21348914Al-Zahrani MS, Bissada NF, Borawskit EA. Obesity and periodontal disease in young, middle-aged, and older adults. J Periodontol. 2003 May;74(5):610-5. doi: 10.1902/jop.2003.74.5.610.
PubMed 12816292Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.
PubMed 25858047Zimmermann GS, Bastos MF, Dias Goncalves TE, Chambrone L, Duarte PM. Local and circulating levels of adipocytokines in obese and normal weight individuals with chronic periodontitis. J Periodontol. 2013 May;84(5):624-33. doi: 10.1902/jop.2012.120254. Epub 2012 Jul 27.
PubMed 22839694Trayhurn P, Beattie JH. Physiological role of adipose tissue: white adipose tissue as an endocrine and secretory organ. Proc Nutr Soc. 2001 Aug;60(3):329-39. doi: 10.1079/pns200194.
PubMed 11681807Balli U, Ongoz Dede F, Bozkurt Dogan S, Gulsoy Z, Sertoglu E. Chemerin and interleukin-6 levels in obese individuals following periodontal treatment. Oral Dis. 2016 Oct;22(7):673-80. doi: 10.1111/odi.12520. Epub 2016 Jul 11.
PubMed 27265537Vazquez-Vela ME, Torres N, Tovar AR. White adipose tissue as endocrine organ and its role in obesity. Arch Med Res. 2008 Nov;39(8):715-28. doi: 10.1016/j.arcmed.2008.09.005.
PubMed 18996284Wozniak SE, Gee LL, Wachtel MS, Frezza EE. Adipose tissue: the new endocrine organ? A review article. Dig Dis Sci. 2009 Sep;54(9):1847-56. doi: 10.1007/s10620-008-0585-3. Epub 2008 Dec 4.
PubMed 19052866Kloting N, Bluher M. Adipocyte dysfunction, inflammation and metabolic syndrome. Rev Endocr Metab Disord. 2014 Dec;15(4):277-87. doi: 10.1007/s11154-014-9301-0.
PubMed 25344447Costford SR, Bajpeyi S, Pasarica M, Albarado DC, Thomas SC, Xie H, Church TS, Jubrias SA, Conley KE, Smith SR. Skeletal muscle NAMPT is induced by exercise in humans. Am J Physiol Endocrinol Metab. 2010 Jan;298(1):E117-26. doi: 10.1152/ajpendo.00318.2009. Epub 2009 Nov 3.
PubMed 19887595Ritchie CS. Obesity and periodontal disease. Periodontol 2000. 2007;44:154-63. doi: 10.1111/j.1600-0757.2007.00207.x. No abstract available.
PubMed 17474931
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Visfatin Levels in Gingival Crevicular Fluid as Potential Biomarker in The Relationship Between Obesity and Periodontal Disease
- ClinicalTrials.gov ID
- NCT03470987
- Acronym / sponsor ID
- OBESITY
- Conditions
- Obesity, Periodontitis
- Keywords
- obesity, periodontitis, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Mar 2018 (actual)
- 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.
Visfatin is an adipokine that plays an important role in immune functions as a growth factor, enzyme, and proinflammatory mediator. The investigators aimed to determine the levels of visfatin, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in gingival crevicular fluid (GCF) in both obese/non-obese patients, with/without generalized chronic periodontitis (GCP). Patients were categorized as obese (O) (n=31) or non-obese (nO) (n=19). Groups were divided into four subgroups according to periodontal conditions: (1) periodontally healthy without obesity (nO-Ctrl); (2) GCP without obesity (nO-CP); (3) periodontally healthy with obesity (O-Ctrl); and (4) GCP with obesity (O-CP). Demographic variables and anthropometric and laboratory data were recorded. Periodontal measurements were recorded at baseline and 3rd months after either non-surgical periodontal treatment or calorie restricted diet therapy. At the same time GCF samples were taken from patients to analyze TNF-alpha, IL-6, and visfatin levels.
Detailed description
Overweightness and obesity are defined as the accumulation of fat in body tissues that might impair overall health. Adults are considered overweight if their body mass index (BMI, calculated as weight in kg/[height in meters]2) is ≥ 25 and obese if BMI ≥ 30 kg/m2. The prevalence of overweightness and obesity has increased worldwide during recent decades.
Obesity is usually related to a chronic low-grade systemic inflammation resulting in significant changes in the concentrations of cytokines and hormones, which subsequently leads to the development of obesity-linked disorders, including insulin resistance, type II diabetes, cardiovascular diseases, dyslipidemia, and metabolic syndrome. Since the host response is among the most crucial factors affecting the pathogenesis of periodontal disease, multiple studies have addressed the possible associations between BMI, overweightness, obesity, diabetes, the serum level of lipids, cholesterol, and periodontal breakdown, with mixed results. Many studies have demonstrated a positive association between obesity and periodontitis and suggested that obesity-related inflammation might promote periodontitis by secretion of inflammatory markers by the adipose tissue, which might subsequently increase gingival inflammation. The association between obesity and periodontal disease is based on the amassing of white adipose tissue (WAT) and increased secretion levels of adipokines from WAT.
WAT is an energy storage organ with some metabolic activities, participating in the endocrine and secretory systems. WAT secretes several immune-modulatory adipokine molecules, such as adiponectin, leptin, visfatin, resistin, chemerin, tumor necrosis factor-alpha (TNF-alpha), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It has been found that these molecules are involved in a wide range of physiologic and pathologic processes, including immunity and inflammation. Thus, cytokines and hormones released from adipose tissue might play a role in the destruction of periodontal tissue by inducing hyperinflammatory responses.
Visfatin is a multi-potential mediator that functions as a growth factor, cytokine, an enzyme with a role in energy metabolism, and as a proinflammatory mediator. It is mainly released from adipose tissue, especially from macrophages, and can also be released from lymphocytes, dendritic, muscle, and bone marrow cells. Visfatin has an important role in the regulation of the immune response. Visfatin inhibits neutrophil apoptosis during inflammation and increases TNF-alpha, IL-1β, and IL-6 levels. The expression of visfatin is increased under inflammatory conditions, such as rheumatoid arthritis, cardiovascular diseases, type-II diabetes mellitus, and periodontal disease.
Although several studies have demonstrated the relationship between periodontitis and obesity, no study has evaluated the levels of visfatin in gingival crevicular fluid (GCF) in obese individuals with periodontitis. Increased adipocytes levels, such as visfatin, cause secretion of cytokines, which are known to play an important role in periodontitis, and might trigger periodontitis formation and development.
Therefore, the main objective of this study was to analyze the levels of visfatin, IL-6, and TNF-alpha in obese and non-obese individuals, with or without generalized chronic periodontitis (GCP). Secondarily, the investigators aimed to evaluate metabolic and clinical periodontal parameters, and also clarify the relationship between these parameters and adipocytokines. The hypothesis is that adipocytokine molecules are involved in the pathogenesis of inflammatory diseases; if true, individuals who are obese with periodontitis would present increased levels of visfatin, IL-6, and TNF-alpha in their GCF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1:nO-Ctrl | – | Procedure: Phase I Periodontal therapyNon-obese patients without generalized chronic periodontitis who were undergone Phase I periodontal therapy |
| Group 2:nO-CP | – | Procedure: Phase I Periodontal therapyNon-obese patients with generalized chronic periodontitis who were undergone Phase I periodontal therapy |
| Group 3: O-Ctrl | – | Procedure: Phase I Periodontal therapy, Dietary Supplement: Metabolic controlObese patients without generalized chronic periodontitis who were undergone metabolic control and Phase I periodontal therapy |
| Group 4: O-CP | – | Procedure: Phase I Periodontal therapy, Dietary Supplement: Metabolic controlObese patients with generalized chronic periodontitis who were undergone metbolic control and Phase I periodontal therapy |
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The 195 patients diagnosed with obesity in the outpatient clinics of Endocrinology and Metabolic Diseases Department, Ataturk Hospital, Turkey, were potential candidates and were interviewed according to our case definition and invited to be included in the study. Thirty-one of 195 volunteers accepted and signed the informed study protocol and took part in the study. All individuals were thoroughly informed of the nature, potential risks, and benefits of their participation in the study before providing their informed consent. In the same period, 100 consecutive non-obese patients were screened from the Department of Periodontology, Faculty of Dentistry, Gazi University, Turkey, who were systemically healthy and fulfilled the inclusion criteria, of which 19 agreed to participate.
Key inclusion criteria (7 listed)
- having > 22 natural teeth
- no systemic diseases
- having good cooperation
- having BMI > 30
- waist circumference > 88 cm for females for obese patients
Key exclusion criteria (9 listed)
- presence of localized chronic periodontitis
- received periodontal therapy/surgery in the previous 6 months
- pregnancy
- use of any hormone therapy
- history of antibiotic or anti-inflammatory drugs therapy within the previous 6 months
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 |
|---|---|---|
| Phase I Periodontal therapyOral hygiene instuction, scaling and root planning | Procedure or surgery | Group 1:nO-Ctrl, Group 2:nO-CP, Group 3: O-Ctrl, Group 4: O-CP |
| Metabolic controlCalorie restricted diet | Dietary supplement | Group 3: O-Ctrl, Group 4: O-CP |
Primary outcome
Cytokine levels in Gingival crevicular fluid
Time frame: Beginning of the study (baseline) and 3 months following Phase I periodontal therapy and metbolic control
Gingival crevicular fluid samples were collected at baseline and repeated at 3rd months following Phase I periodontal therapy and metabolic control. In the periodontally healthy group, samples were obtained from maxillary anterior four teeth exhibiting probing depth < 3mm without clinical attachment level or bleeding on probing. Four sites from each tooth were used for Gingival crevicular fluid sampling. In the generalized chronic periodontitis groups, Gingival crevicular fluid samples were collected from four teeth with bleeding on probing, probing depth≥ 5 mm, clinical attachment level≥ 5 mm, and 30% bone loss. Visfatin, TNF alpha and IL-6 levels in these fluid samples were determined using an enzyme-linked immunosorbent assay (ELISA).
5 secondary outcomes
Clinical attachment level
Time frame: Change from baseline clinical attachment level to 3rd month level
Probing depth
Time frame: Change from baseline probing depth value at 3rd month value
Bleeding on probing
Time frame: Change from baseline bleeding on probing score to 3rd month score
Gingival index
Time frame: Change from baseline gingival index score to 3rd month score
Plaque index
Time frame: Change from baseline plaque index score to 3rd month score
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 21 Mar 2018.
- Background: PubMed 25672656Keller A, Rohde JF, Raymond K, Heitmann BL. Association between periodontal disease and overweight and obesity: a systematic review. J Periodontol. 2015 Jun;86(6):766-76. doi: 10.1902/jop.2015.140589. Epub 2015 Feb 12.
- Background: PubMed 21348914Suvan J, D'Aiuto F, Moles DR, Petrie A, Donos N. Association between overweight/obesity and periodontitis in adults. A systematic review. Obes Rev. 2011 May;12(5):e381-404. doi: 10.1111/j.1467-789X.2010.00808.x. Epub 2011 Feb 23.
- Background: PubMed 12816292Al-Zahrani MS, Bissada NF, Borawskit EA. Obesity and periodontal disease in young, middle-aged, and older adults. J Periodontol. 2003 May;74(5):610-5. doi: 10.1902/jop.2003.74.5.610.
- Background: PubMed 25858047Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.
- Background: PubMed 22839694Zimmermann GS, Bastos MF, Dias Goncalves TE, Chambrone L, Duarte PM. Local and circulating levels of adipocytokines in obese and normal weight individuals with chronic periodontitis. J Periodontol. 2013 May;84(5):624-33. doi: 10.1902/jop.2012.120254. Epub 2012 Jul 27.
- Background: PubMed 11681807Trayhurn P, Beattie JH. Physiological role of adipose tissue: white adipose tissue as an endocrine and secretory organ. Proc Nutr Soc. 2001 Aug;60(3):329-39. doi: 10.1079/pns200194.
- Background: PubMed 27265537Balli U, Ongoz Dede F, Bozkurt Dogan S, Gulsoy Z, Sertoglu E. Chemerin and interleukin-6 levels in obese individuals following periodontal treatment. Oral Dis. 2016 Oct;22(7):673-80. doi: 10.1111/odi.12520. Epub 2016 Jul 11.
- Background: PubMed 18996284Vazquez-Vela ME, Torres N, Tovar AR. White adipose tissue as endocrine organ and its role in obesity. Arch Med Res. 2008 Nov;39(8):715-28. doi: 10.1016/j.arcmed.2008.09.005.
- Background: PubMed 19052866Wozniak SE, Gee LL, Wachtel MS, Frezza EE. Adipose tissue: the new endocrine organ? A review article. Dig Dis Sci. 2009 Sep;54(9):1847-56. doi: 10.1007/s10620-008-0585-3. Epub 2008 Dec 4.
- Background: PubMed 25344447Kloting N, Bluher M. Adipocyte dysfunction, inflammation and metabolic syndrome. Rev Endocr Metab Disord. 2014 Dec;15(4):277-87. doi: 10.1007/s11154-014-9301-0.
- Background: PubMed 19887595Costford SR, Bajpeyi S, Pasarica M, Albarado DC, Thomas SC, Xie H, Church TS, Jubrias SA, Conley KE, Smith SR. Skeletal muscle NAMPT is induced by exercise in humans. Am J Physiol Endocrinol Metab. 2010 Jan;298(1):E117-26. doi: 10.1152/ajpendo.00318.2009. Epub 2009 Nov 3.
- Background: PubMed 17474931Ritchie CS. Obesity and periodontal disease. Periodontol 2000. 2007;44:154-63. doi: 10.1111/j.1600-0757.2007.00207.x. No abstract available.
- Individual participant dataSharing planned: No
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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.
Deniz Cetiner, Prof study chair
Gazi University Faculty of Dentistry Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Periodontitis, run by Gazi University at 1 site in Turkey (Türkiye).
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 7 inclusion and 9 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 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cytokine levels in Gingival crevicular fluid (time frame: Beginning of the study (baseline) and 3 months following Phase I periodontal therapy and metbolic control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470987, which also lists 12 linked publications.
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 21 Mar 2018.