Chemerin, Fetuin-A, IL-34 and IL-13 Levels in Diabetic Periodontitis Patients
NCT ID: NCT06135532
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2018-10-01
2020-02-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Periodontal Treatment on Adipokine Levels
NCT06225154
Effect of Periodontal Therapy on Biomarkers in Periodontitis
NCT05005923
Gingival Crevicular Fluid, Salivary, and Serum Biomarkers Levels in Periodontal Treatment
NCT05395455
Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Biomarker Levels
NCT06175624
Effect of Periodontal Treatment on Inflammasome Proteins in Periodontal Diseases
NCT06075680
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Chemerin, an adipose tissue-specific adipokine, influences the glucose pathway, lipid metabolism, inflammation levels, chemotaxis of immature dendritic cells, and integration of macrophage-phagocytic activity to extracellular matrix proteins and adhesion molecules. Fetuin-A impedes insulin receptor tyrosine kinase, thus affiliated with insulin resistance, metabolic syndrome, and an increased risk for type 2 diabetes mellitus. Interleukin (IL)-34 modulates myeloid cell differentiation, proliferation, and survival. Depending on the microenvironment, IL-34 can transform circulating monocytes into specific non-resident macrophages with a "pro-inflammatory" M1 phenotype or an "anti-inflammatory" M2 phenotype. IL-13 inhibits the release of inflammatory cytokines, such as IL-1, IL-6, and TNF-α, from monocytes and macrophages.
This study is the first controlled clinical study that examines the levels of chemerin, fetuin-A, IL-34, and IL-13 in saliva and serum in periodontitis with and without T2DM (well-controlled and poorly-controlled T2DM) and evaluates the situation before and after the treatment. The first hypothesis of this study is that in periodontitis groups, chemerin and IL-34 levels will be high in saliva and serum, and IL-13 and fetuin-A levels will be low in contrast to the non-periodontitis groups. The second hypothesis of this study is that in T2DM groups, fetuin-A and chemerin levels will be high compared to participants without T2DM. The third hypothesis of this study, after periodontal treatment, chemein and IL-34 levels will decrease, and IL-13 and fetuin-A will increase in saliva and serum. Based on these hypotheses, the study aims to compare the levels of chemerin, fetuin-A, IL-34, and IL-13 in saliva and serum of nonperiodontitis controls (NP), NP with T2DM (DM.NP), periodontitis (P), P with well-controlled T2DM (WDM.P) and P with poorly-controlled T2DM (PDM.P) subjects and to evaluate the effect of periodontal treatment.
A total of 110 participants, 22 NP, 22 DM.NP, 22 P, 22 WDM.P, and 22 PDM.P were included in this study. The whole mouth clinical periodontal examination included measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites per tooth, except the third molars. The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.
The periodontal status of each patient was evaluated by a single calibrated periodontist with a manual probe. The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. NP individuals (healthy and gingivitis) (n=22) in the control group had no sites with PD \>3 mm and CAL \>2 mm and no radiographic evidence of alveolar bone loss. NP group also exhibited no history of periodontitis. The periodontitis stage III/IV patients had a minimum of three teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm. Radiographic bone loss extending from coronal to middle third or beyond. Bone loss %/age was higher than 1.0.
The diagnosis of patients with T2DM was based on the criteria given by the World Health Organization. Both well-controlled and poorly-controlled diabetic patients, diagnosed at least one year ago as having T2DM and treated with oral anti-diabetics and/or insulin, no major diabetic complications (retinopathy, nephropathy, neuropathy), were included.
Treatment
The recruited periodontitis patients received conventional quadrant scaling and root planning (SRP) under local anesthesia in a total of 4 sessions in four weeks. SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes. Re-evaluations were performed at 1 and 3 months following the completion of the SRP. No periodontal intervention was carried out in the non-periodontitis controls.
Saliva and serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 9:00 and 10:00 a.m. The participants were advised to avoid food consumption for three hours before sample collection. The participants were seated upright, and saliva was collected over 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker. Then, saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80°C. A total of 10,5 mL of blood was collected from the antecubital fossa by the venepuncture method. Serum was isolated from the blood by centrifuging at 4000 rpm for 12 minutes, followed by its rapid transfer to a sterile polypropylene tube and storage at -80°C.
Biomarker Immunoassays Saliva and serum samples were thawed on ice. The saliva samples were centrifuged at 5000 rpm for 15 minutes at room temperature, and supernatants were immediately used for assays. Using commercial kits, serum and salivary samples of chemerin, fetuin-A, IL-34, and IL-13 were measured by ELISA.
Statistical Analysis Shapiro Wilk's normality test was applied to determine the clinical and biochemical data distribution. Nonparametric tests were used because the variables did not follow a normal distribution. The gender distributions among groups were analyzed using the Chi-Square test. Multiple comparisons of the clinical and biochemical parameters were analyzed using the Kruskal-Wallis; if significance occurred, the Bonferroni-adjusted Mann-Whitney U test was applied for paired comparisons. Intragroup comparisons were performed using the Wilcoxon signed-rank test. The correlations among clinical and biochemical parameters at baseline were performed using Spearman's rank correlation analysis. Multinomial logistic regression was used to determine associations between periodontitis groups and biochemical parameters. The level of significance was set at P \< 0.05.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-Periodontitis
Only received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.
No interventions assigned to this group
Non-Peridontitis with T2DM
Only received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.
No interventions assigned to this group
Periodontitis
The patients received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.
The patients underwent quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment was completed in a total of 4 sessions in four weeks.
Non-Surgical Periodontal Treatment
Nonsurgical periodontal therapy primarily aims to control microbial periodontal infection by removing bacterial biofilm, calculus, and toxins from periodontally involved root surfaces. Performing a thorough periodontal debridement under local anesthesia will stop disease progression and improve active disease's clinical signs and symptoms.
Periodontitis with well-controlled T2DM
The patients received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.
The patients underwent quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment was completed in a total of 4 sessions in four weeks.
Non-Surgical Periodontal Treatment
Nonsurgical periodontal therapy primarily aims to control microbial periodontal infection by removing bacterial biofilm, calculus, and toxins from periodontally involved root surfaces. Performing a thorough periodontal debridement under local anesthesia will stop disease progression and improve active disease's clinical signs and symptoms.
Periodontitis with poorly-controlled T2DM
The patients received instructions in proper self-performed plaque control measures, including brushing and interproximal cleaning with dental floss and interdental brushes.
The patients underwent quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment was completed in a total of 4 sessions in four weeks.
Non-Surgical Periodontal Treatment
Nonsurgical periodontal therapy primarily aims to control microbial periodontal infection by removing bacterial biofilm, calculus, and toxins from periodontally involved root surfaces. Performing a thorough periodontal debridement under local anesthesia will stop disease progression and improve active disease's clinical signs and symptoms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-Surgical Periodontal Treatment
Nonsurgical periodontal therapy primarily aims to control microbial periodontal infection by removing bacterial biofilm, calculus, and toxins from periodontally involved root surfaces. Performing a thorough periodontal debridement under local anesthesia will stop disease progression and improve active disease's clinical signs and symptoms.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* having ≥20 teeth present (except third molars)
* individuals with non-periodontitis (healthy or gingivitis) and stage III grade C periodontitis diagnoses
* diagnosed at least one year ago as having T2DM and treated with oral anti-diabetics and/or insulin, no major diabetic complications (retinopathy, nephropathy, neuropathy)
Exclusion Criteria
* usage of antibiotics, non-steroidal anti-inflammatory drugs, and immunosuppressive agents within the past 6 months.
* periodontal treatment within the preceding 6 months.
* pregnant/ lactating/ postmenopausal females.
* current orthodontic treatment.
23 Years
69 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Marmara University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hatice Selin Yıldırım, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marmara University
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gorgulu NG, Gungormek HS, Kalkan Y, Dogan B. Evaluation of chemerin, fetuin-A, interleukin-34, and interleukin-13 levels following periodontal treatment in diabetes mellitus. Clin Oral Investig. 2025 Sep 11;29(10):448. doi: 10.1007/s00784-025-06539-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAG-A-080519-0172
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.