Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in subjective dry mouth score
研究概览
简要总结
Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
详细描述
A pre-post test trial was conducted in 120 elders with xerostomia. All subjects received a total of 50 ml (10ml x 5 times) OMJ per day. Subjective and objective dry mouth scores, salivary pH, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. The data were analyzed by Repeated Measure ANOVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth
- •Report symptoms of dry mouth
排除标准
- •Subjects with uncontrolled systemic diseases
- •Subjects who aspirate upon eating
- •Subjects who smoke
- •Subjects who are allergic to component of the intervention
结局指标
主要结局
Changes in subjective dry mouth score
时间窗: baseline, 2 weeks and 4 weeks after intervention
The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
次要结局
- Changes in salivary buffering capacity(baseline, 2 weeks and 4 weeks after intervention)
- Satisfaction of the edible gel-based artificial saliva(at the first day of trial)
- Changes in objective dry mouth score(baseline, 2 weeks and 4 weeks after intervention)
- Changes in salivary Potential of Hydrogen ion (pH)(baseline, 2 weeks and 4 weeks after intervention)