Possible Role of Gingival Crevicular Fluid Levels of Chemerin and Fibroblast Growth Factor 21 as Biomarkers of Periodontal Disease in Diabetic and Non-diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls
研究概览
简要总结
The current study aims to spot the light on the possible role of gingival crevicular fluid (GCF) level of Chemerin and FGF21 to study their potential role as biomarkers of periodontal disease and to understand their role in the link between periodontitis and diabetes .
The study will be conducted on three groups; group (A) include fifteen controlled T2 DM patients suffering from periodontitis, group (B) include fifteen patients suffering from periodontitis alone, and group C) include fifteen periodontally and medically healthy individuals. GCF samples will be collected from all participants for assessment of Chemerin and FGF 21. Samples will be analysed using ELISA technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age range between 35 and 60 years
- •a minimum of 20 natural teeth.
- •Type 2DM patients exhibiting HbA1c 6-8% and FPG ≥126 mg/dL for more than one year who did not complain of any systemic diseases other than t2DM
- •periodontitis patients with moderate to severe periodontitis having gingival index GI ≥ 1, probing depth PD ≥ 5, and clinical attachment level CAL ≥ 4 mm, and bone loss affecting > 30% of existing teeth on clinical/radiographic examination
- •Exclusion criteria
- •uncontrolled diabetes mellitus
- •systemic diseases which may affect the biomarkers levels and the periodontal conditions.
- •Exposure to steroid therapies, radiation/immune-suppressive therapies.
- •Allergic reaction to any kind of drug.
- •Smoking over the past 5 years.
- •Periapical pathologies.
- •Exposure to mechanical forces as a result of occlusion/ orthodontics.
- •History of periodontal or drug therapies within the previous 6 months.
排除标准
- 未提供
结局指标
主要结局
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls
时间窗: baseline
assessment of GCF FGF21 in healthy individuals
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis
时间窗: baseline
assessment of GCF FGF21 in diabetic patients with periodontitis
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients
时间窗: baseline
assessment of GCF FGF21 in patients with periodontitis
次要结局
- measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of diabetic patients with periodontitis(baseline)
- measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients(baseline)
- measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls(baseline)
研究者
Eman Mohamed Amr
Associate Professor
Cairo University