DRKS00009685已完成4 期
Randomized double-blind crossover study to compare the efficacy of GUM HYDRAL Mouth Wash and Gel versus Biotene Mouth wash and Gel on medication-induced xerostomia (MPG23b)
Abteilung für Zahnerhaltung und Parodontologie0 个研究点目标入组 40 人开始时间: 2015年11月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Minimum age: at least 18 years of age
- •Written informed consent
- •Daily intake of at least one drug with medication-induced xerostomia as declared side effect in the product insert (the patient will be asked at the beginning of the trial about taken drug names and application rates) and as it is stated in the attached Hydral Medications List and in (Screebny et al.)
- •Subjective xerostomia: Minimum level of xerostomia on a VAS scale: 4 of 10
- •Minimum number of teeth: 4
排除标准
- •Any allergic or undesired condition stated in the case history on one of the study product ingredients
- •Pregnancy or planned pregnancy during the study
- •Current or anamnestic radiation therapy or chemotherapy
- •Current or anamnestic parotid malignancy
- •Current or anamnestic head/neck malignancy
- •Current or anamnestic surgery in the head/neck region
- •Sjögren’s syndrome
- •Other medical reasons for xerostomia without drug intake
- •Current daily intake of symptom alleviating products against xerostomia (other than high frequent water intake)
- •Smoking of more than 10 cigarettes/day
研究者
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