NCT06194123进行中（未招募）不适用
Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective 1- Visual Analogue Scale for Perceived Dry Mouth
研究概览
简要总结
The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •At least 18 years of age.
- •Can produce an unstimulated salivary flow rate of 0.18mL/min. or less.
- •Score of 3 or more on question 1 of the VAS dry mouth scale (How severe is your dryness right now?), evaluated in the Pre-Product Use Dry Mouth & Sensitivity Questionnaire.
- •Evidence of currently taking a stable dose (3 months or more) of Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines and etc.
- •At screening, participants may present the prescription bottle, a picture of the prescriptions bottle or medical records showing the prescription.
- •Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne, Pronamel etc.
- •Subject willing to comply with the study regimen and products.
- •Not consume alcohol for 24 hours prior to their visit.
- •Not brush their teeth for 1.5 hours prior to their visit.
- •Not have had anything to eat or drink (including chewing gum or eating candy) for 1.5 hours prior to their visit). Water is acceptable to drink up to 1 hour prior to the study visit.
- •Not smoke 1.5 hours prior to their visit
排除标准
- •i. Subjects who are currently pregnant (self-reported). ii. Unstimulated salivary flow rate of more than 0.18mL/min iii. Subjects that have ever received therapeutic radiation in the head and neck area.
- •iv. Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome per the investigator's expert opinion.
- •v. Subjects with a condition the investigator believes not suitable for the study, such as autoimmune diseases and radiation therapy to head and neck region that impact salivary flow.
- •vi. Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.
- •vii. Subjects currently participating in any other research studies. viii. Subject unable to provide consent (e.g. Cognitively impaired adults). ix. Non-English speaking
研究组 & 干预措施
Experimental
Experimental
All subjects will be instructed to use the Crest Daily Whitening Serum for 1 week as described on the label. This product is available for purchase at any pharmacy.
干预措施: Crest Daily Whitening Serum (Other)
结局指标
主要结局
Objective 1- Visual Analogue Scale for Perceived Dry Mouth
时间窗: 5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.
To observe presence and degree of reduction in the self-reported subjective perception of dryness in the oral cavity at different time intervals after the application of a Whitening Agent with Emulsion Gel in Xerostomic Population
次要结局
- Objective 2- Visual Analogue Scale for Perceived Bad Breath and Saliva Production Increase(60 minutes post application as well as degree of change after a 7 day period of use.)
研究者
研究点 (1)
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