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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/077 | Other Grant/Funding Number | University of Health Sciences Scientific Research Projects |
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The goal of this observational study is to learn about how different periodontal health status affects the levels of asprosin (a hormone) and total oxidant/antioxidant status in the gingival crevicular fluid and blood serum of individuals with Type 2 diabetes.
The main questions it aims to answer are:
Do individuals with Type 2 diabetes and periodontal disease have different levels of asprosin and oxidative stress markers compared to diabetic individuals with healthy gingiva ?
How do local changes in the gingiva relate to systemic (body-wide) biomarkers in diabetic patients?
Participants with Type 2 diabetes will undergo a routine clinical periodontal examination to evaluate their gingival health. During their regular clinic visit, samples of fluid from around their gingiva (gingival crevicular fluid) and routine blood samples (serum) will be collected to measure and compare these biochemical markers
This prospective, observational cross-sectional study aims to investigate the impact of various periodontal conditions on local and systemic levels of asprosin, total oxidant status (TOS), and total antioxidant status (TAS) in individuals with Type 2 diabetes mellitus. The primary objective is to evaluate whether localized periodontal inflammation modulates these specific biochemical markers in the presence of an underlying systemic metabolic condition like diabetes.
Participants diagnosed with Type 2 diabetes mellitus will be recruited from patients visiting the clinic. Based on a comprehensive clinical periodontal examination, participants will be categorized into distinct groups according to their periodontal health status (such as periodontal health, gingivitis, or periodontitis, based on current classification criteria). Clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP), will be recorded for all subjects.
Prior to any clinical measurements or mechanical periodontal treatment, site-specific sampling will be performed. Gingival crevicular fluid (GCF) samples will be collected from selected teeth using paper strips. In addition, routine venous blood samples will be obtained from each participant to separate the serum.
The collected GCF and serum samples will be stored at -80 degrees Celsius until laboratory analysis. Biochemical evaluations will be conducted using Enzyme-Linked Immunosorbent Assay (ELISA) kits to quantify asprosin levels, while spectrophotometric methods will be utilized to determine Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) levels. Statistical analyses will be performed to compare the biomarker levels among the different periodontal groups and to assess the correlations between clinical periodontal parameters and biochemical data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal health | Systemic and periodontal health participants | ||
| Gingivitis | Type 2 Diabetes and gingivitis | ||
| Periodontitis | Type 2 Diabetes and periodontitis |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions. | At a single study visit during enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of serum and gingival crevicular fluid total oxidant status and total antioxidant status levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions. | At a single study visit during enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consisted of adults aged 18-65 years. The gingivitis and periodontitis groups included patients diagnosed with type 2 diabetes mellitus (T2DM), whereas the healthy control group consisted of systemically healthy individuals. Participants were required to be non-smokers, have more than 20 natural teeth, and have no systemic conditions or medication use that could affect the immune response of the periodontal tissues.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Türkiye, Gülhane Faculty of Dentistry | Ankara | Ankara | 06100 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Related Info | View source |
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De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator following publication of the study results.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2026 | Jun 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2026 | Jun 17, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D005882 | Gingival Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D054119 | Arachnodactyly |
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007239 | Infections |