Gingival Crevicular Fluid and Salivary Levels of Neuregulin-4 and Its Receptor ErbB4 in Patients With Stage III and IV Periodontitis With and Without Type 2 Diabetes: An Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The receptor ErbB4 in the GCF
研究概览
简要总结
The aim of this study is to assess the levels of neuregulin-4 and its receptor ErbB4 in the GCF and saliva in stage III and IV periodontitis patients with and without type 2 diabetes mellitus.
详细描述
The aim of this study is to measure the levels of Nrg4 and ErbB4 in the GCF and saliva of periodontitis stage III and IV patients with and without type 2 diabetes mellitus and to correlate their levels with the periodontal clinical parameters and the blood glucose levels including the fasting plasma glucose level (FPG) and glycated hemoglobin (HbA1c).
This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For periodontitis stage III and IV patients according to (Papapanou et al., 2018 and Tonetti et al., 2018)
- •Bleeding on probing (BOP) ≥ 30%.
- •At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD ≥ 6 mm in one or more sites.
- •Tooth loss due to periodontitis ≥ 5 teeth.
- •Presence of a minimum of 15 natural teeth. For diabetes and non-diabetic patients according to ("Diagnosis and Classification of Diabetes Mellitus," 2014)
- •Patients with type 2 diabetes mellitus will be diagnosed as having type 2 diabetes mellitus ≥ 5 years before the study and treated with stable doses of oral hypoglycaemic agents and/or insulin under the supervision of an endocrinologist with their glycated haemoglobin level (HBA1c) > 6%.
- •Non diabetic Patients in the control and stage III and IV periodontitis groups will be selected as having Fasting plasma glucose (FPG) <126 mg/dL.
排除标准
- •Individuals with any known systemic disease other than type 2 diabetes.
- •Pregnant and lactating women.
- •Individuals that received periodontal treatment within the last 6 months.
- •Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
- •Former or current smokers.
结局指标
主要结局
The receptor ErbB4 in the GCF
时间窗: 6 month
Measured by Enzyme-Linked Immunosorbent Assay in μL
The receptor ErbB4 in saliva
时间窗: 6 month
Measured by Enzyme-Linked Immunosorbent Assay in μL
Neuregulin-4 in the GCF
时间窗: 6 month
Measured by Enzyme-Linked Immunosorbent Assay in μL
Neuregulin-4 in the saliva
时间窗: 6 month
Measured by Enzyme-Linked Immunosorbent Assay in μL
次要结局
- Fasting plasma Glucose Level (FPG)(6 month)
- Body Mass Index (BMI)(6 month)
- Pocket depth(6 month)
- Glycosylated Haemoglobin (HbA1c %)(6 month)
- Bleeding on probing(6 month)
- Clinical attachment level(6 month)
- plaque index(6 month)
研究者
Asmaa Samir Abdel Fatah
Asmaa Samir
Cairo University