NCT04186806已完成不适用
An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 10 cm Mouth Dryness Visual Analog Score
研究概览
简要总结
The purpose of the clinical trial is to evaluate and validate the performance of the experimental mouth spray when used by persons with mild to severe dry mouth symptoms.
详细描述
The purpose of this study is to investigate the efficacy of 3M Dry Mouth Moisturizing Spray to reduce symptoms of dry mouth for up to 4 hours and after 7 days of use. In addition, this study aims to support comparative claims.
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
- Single (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
- •Screening - Start of Wash-In Visit
- •Subject who is ≥18 years of age and complains of dry mouth
- •Only 1 subject per household is allowed into study
- •Subject with a Challacombe scale score of 1 or higher
- •Subject agrees to refrain from eating spicy foods and foods containing garlic beginning 48-hours prior to all study visits
- •Subject agrees to eat a meal prior to all study visits that include sample evaluation in the clinic
- •Subject agrees to not eat, drink, chew tobacco, chew gum, smoke, brush or floss teeth for 2-hours prior to sample evaluation study visits
- •Subject agree to not use any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
- •Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
- •Subject agrees to only use those clinical oral care supplies provided during the entire study
- •Able to understand and willing to sign the Informed Consent Form
- •Water Only Evaluation Visit
- •Subject has successfully completed a ≥ 2-day wash-in period
- •Subject has Challacombe scale score of 1 or higher
- •Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to the sample evaluation visits
- •Subject ate a meal prior to sample evaluation study visits
- •Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
- •Subject has not used any oral care products, any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
- •Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
- •Subject has used only those clinical oral care supplies provided during study
- •Baseline Period 1/Randomization Visit
- •Subject has successfully completed a ≥ 2-day wash-in period
- •Subject has a Challacombe Scale score of 1 or higher
- •Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to sample evaluation study visits
- •Subject ate a meal prior to sample evaluation study visits
- •Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
- •Subject has not used any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
- •Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
- •Subject has used only those clinical oral care supplies provided during study
排除标准
- •Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline Period 1 (Randomization Visit)
- •Subject has active mouth sores (e.g., cold sores, cuts, burns, canker sores)
- •Subject has a life-threatening pathological condition
- •Subject is participating in another clinical trial at the time of the study
- •Subject has profound marginal periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
- •Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study
- •Difficult to be compliant with recalls, such as extensive travel commitments, lack of transportation etc.
结局指标
主要结局
10 cm Mouth Dryness Visual Analog Score
时间窗: 15 minutes post dose
Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms.
次要结局
- 10 cm Mouth Dryness Visual Analog Score(120 minutes)
- 10 cm Mouth Dryness Visual Analog Scale(30 minutes)
- Response to Soothing in the Mouth(240 minutes)
- 10 cm Mean Mouth Dryness Visual Analog Score(5 minutes)
- 10 cm Mean Mouth Dryness Visual Analog Scale(120 minutes)
- Response on Dry Mouth Relief(240 minutes)
- Response to Effectively Moistens the Mouth(240 minutes)
- Response to Effectively Lubricates the Mouth(240 minutes)
- Response to Feel Comfortable in the Mouth(240 minutes)
研究者
研究点 (2)
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