Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in minor salivary flow rates at 60 minutes
研究概览
简要总结
The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •xerostomia for 3 months or more, and
- •adults aged 20 years and older.
排除标准
- •acute asthma attack
- •acute iritis
- •narrow angle glaucoma
- •pilocarpine allergy
- •pregnancy
- •lactating women, and
- •person who was treating xerostomia with artificial saliva, pilocarpine, or etc.
研究组 & 干预措施
0.1% pilocarpine mouthwash
0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline
干预措施: Pilocarpine (Drug)
0.9% saline mouthwash
0.9% saline as a mouthwash
干预措施: saline (Drug)
结局指标
主要结局
Change from baseline in minor salivary flow rates at 60 minutes
时间窗: before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Minor salivary flow rates (from buccal, lower labial and palatal mucosa) were measured before and after using the mouthwash at predetermined times: baseline, immediately (0 min), and 30 and 60 minutes after. The Periotron 8000 device (Oraflow, New York, USA)was used to measure the flow rate (µl/cm2 per min) of saliva from the minor glands, in accordance with the method of Eliasson et al. (1996).
次要结局
- Change from baseline in the severity of oral dryness at 60 minutes(Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes))
- Change from baseline in the unstimulated whole salivary flow rates at 60 minutes(Before and after using mouthwash (baseline, 60 minutes))
- Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks(4 weeks)
研究者
Jeong-seong Kwon
Clinical assistant professor
Yonsei University