The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- evaluation of saliva parameters od day 1
研究概览
简要总结
Methods: 100 consecutive patients with their first ever ischemic stroke were enrolled in the study. 56 randomly selected patients were subjected to stimulation of salivation, the remaining patients were not stimulated. The severity of the neurological condition was assessed using the NIHSS scale on days 1, 3 and 7 of stroke. The incidence of periodontal diseases was classified using the Hall's scale in the 1st day of stroke. On days 1 and 7 of stroke, the concentration of IL-1beta, MMP8, OPG and RANKL in the patients' saliva was assessed using the Elisa technique. At the same time, the level of CRP and the number of leukocytes in the peripheral blood were tested on days 1, 3 and 7 of the stroke, and the incidence of upper respiratory and urinary tract infections was assessed.
详细描述
The course of an ischemic stroke varies by many factors. The influence of periodontal diseases and the stimulation of salivation on the course and difficulty of stroke remains unresolved.
Methods: 100 consecutive patients with their first ever ischemic stroke were enrolled in the study. 56 randomly selected patients were subjected to stimulation of salivation, the remaining patients were not stimulated. The severity of the neurological condition was assessed using the NIHSS scale on days 1, 3 and 7 of stroke. The incidence of periodontal diseases was classified using the Hall's scale in the 1st day of stroke. On days 1 and 7 of stroke, the concentration of IL-1beta, MMP8, OPG and RANKL in the patients' saliva was assessed using the Elisa technique. At the same time, the level of CRP and the number of leukocytes in the peripheral blood were tested on days 1, 3 and 7 of the stroke, and the incidence of upper respiratory and urinary tract infections was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 48 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women,
- •at the age of 48-80,
- •first-ever stroke,
- •with symptoms from the anterior cerebral vascularity (basin of the internal carotid artery),
- •with a significant neurological deficit (minimum 3 points according to the NIH scale)
- •capable of giving informed consent;
排除标准
- •aphasia, disturbance of consciousness, mental disorders - making it impossible to express informed consent
- •surgery of the salivary glands - disrupting the secretion of saliva
- •diseases of the salivary glands that disrupt the secretion of saliva (diabetes, Sjögren's syndrome, state after radiotherapy in the area of the salivary glands)
结局指标
主要结局
evaluation of saliva parameters od day 1
时间窗: day 1 of stroke
On the first day of admission, saliva (2 ml) is collected and the parameters are MMP8 (ng/mL), OPG ( (ng/mL) and RANKL (ng/mL)
assessment of blood parameters from day 1
时间窗: day 1 of stroke
Assessment of CRP(mg/L) in blood on the first day of hospitalization
次要结局
- evaluation of saliva parameters- second measurement(day 7 of stroke)
- assessment of blood parameters from day 7(day 7 of stroke)