Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 804
- 主要终点
- occurrence of oral mucositis
研究概览
简要总结
This study included rheumatoid arthritis patients receiving Methotrexate as monotherapy. All eligible patients were subjected to thorough clinical examination and full history to identify oral events. Drug history, current dose and duration of MTX were recorded.
详细描述
The current study was conducted in the Clinics of Oral Medicine, Faculty of Dentistry and Rheumatology, Faculty of Medicine - Cairo University from 2017 to 2019. This study followed the principles of the Helsinki Declaration and was approved by the Research ethics committee of Faculty of Dentistry, Cairo University.
RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded.
All eligible patients were subjected to thorough clinical examination for the whole oral cavity. Medical history and history of any oral manifestation were recorded. Drug history, dose, and duration of MTX were recorded.
Categorical data was presented as frequencies and percentages. Continuous data was described as means and standard deviations. Means were compared by one-way ANNOVA and Student-t-test. The significance level was set at P ≤0.05. Statistical analysis was performed with IBM® SPSS® Statistics Version 25 for Windows.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Rheumatoid arthritis using methotrexate as sole treatment
排除标准
- •patients with Rheumatoid arthritis using any other treatments for Rheumatoid arthritis
结局指标
主要结局
occurrence of oral mucositis
时间窗: throughout the study time (one year)
Clinical examination (intra-oral) and history of oral mucositis where recorded
次要结局
未报告次要终点
研究者
Eman Magdy Ahmed
Lecturer of oral medicine
Beni-Suef University