NCT03663231已完成不适用
Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Mean Duration of Action of Intervention
研究概览
简要总结
To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are in good general health and reply initially affirmatively to the question, "Do you feel that your mouth is too dry and causes you discomfort at times during the day other than on awakening from sleep?" This question is an adaptation of the question used successfully by Jose and others (2016) to recruit study subjects.
- •Adults who are able to communicate easily in English and who are able to demonstrate understanding of the study instructions.
- •Adults who are physically able to perform an unstimulated whole saliva flow rate (UWSFR) test and who produce 0.2 mL/min or less of saliva.
排除标准
- •Adults under the care of a health professional specifically for xerostomia treatment, including those taking prescription systemic parasympathetic medications.
- •Adults who regularly "self-medicate" their xerostomia with water or other agents or products designed to treat their xerostomia and are unwilling or unable to cease use of the agent for at least 48 hours prior to the two test visits.
- •Adults who are primarily mouth breathers (i.e. mouth breathing secondary to nasal obstruction)
- •Adults who cannot consent for themselves or have physical/mental disabilities requiring a caregiver.
- •Adults with a known allergy to any of the ingredients in Biotène Spray (eg. dairy allergy)
结局指标
主要结局
Mean Duration of Action of Intervention
时间窗: baseline up to 2 hours
Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action.
次要结局
- Mean Continued Use of Project(2 hours)
- Mean Preference for Another Product(2 hours)
- Mean Ease of Use of Product(2 hours)
- Mean Acceptability of Product(2 hours)
- Mean Tolerability of Product(2 hours)
- Mean Purchase Product Rating(2 hours)
研究者
Ralph Saunders
Professor
University of Rochester
研究点 (2)
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