Prevalence Of Oral Mucosal Alterations In a Sample of Egyptian Patients With Diabetes Mellitus Type2: A Hospital Based Cross Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Oral mucosal alterations
研究概览
简要总结
There are severe deficiency of database concerning the oral health status in Egyptian patients with Diabetes type 2. Our aim in the present study is to study the prevalence of oral mucosal alterations in type 2 DM patients and the effect of hyperglycemia on these alterations in controlled and uncontrolled patients to increase their awareness and minimize all the possible risk factors,to achieve a proper management for all oral problems.
详细描述
The study will be held in the Endocrine clinic at El Kasr Al-Ainy Cairo University Hospital for patients with diabetes mellitus type2. The data collected through the questionnaire will be obtained through an interview between the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland function will be determined through a small questionnaire and clinical examination of the patient.
Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic.
Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study.
Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record.
Sample size estimation:
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Patients >25years old
- •Patients diagnosed with diabetes type
- •Egyptian patients.
排除标准
- •females diagnosed with gestational diabetes.
- •Patients not physically able to participate in survey or clinical oral examination.
- •Patients with other systemic diseases which may cause oral manifestation as liver disorders.
- •Patients under immunosuppressive drugs.
- •Patients under corticosteriods.
- •Patients with organ transplantation.
结局指标
主要结局
Oral mucosal alterations
时间窗: 10 min
Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).
次要结局
- Periodontal condition(10 min)
- Salivary glands function(10 min)
研究者
Alaa Mahmoud abd El kader
principle investigator, internal resident at oral medicine department
Cairo University