Evaluation of the Effects of Different Periodontal Statuses on Asprosin and Total Oxidant/Antioxidant Levels in Gingival Crevicular Fluid and Serum of Patients With Type 2 Diabetes: A Cross-sectional Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with type 2 diabetes mellitus (T2DM) in the gingivitis and periodontitis groups
- •Systemically healthy individuals without any systemic disease in the healthy control group
- •Age between 18 and 65 years
- •Non-smokers
- •Individuals with no diseases or medication use that could alter the immune response of the periodontal tissues
- •Participants with more than 20 natural teeth
排除标准
- •Age younger than 18 years or older than 65 years
- •Individuals with any disease or medication use that could alter the immune response of the periodontal tissues
- •Pregnant women
- •Individuals who had received periodontal treatment within the previous 6 months
- •Patients with type 1 diabetes mellitus (T1DM)
- •Individuals who had used antibacterial medications within the previous 6 months
结局指标
主要结局
Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.
时间窗: At a single study visit during enrollment
次要结局
- 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)
研究者
Oğuz Koca
Research Assistant
Saglik Bilimleri Universitesi