NCT02384044已完成不适用
A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen
Procter and Gamble2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change From Baseline Visual Analog Scale
研究概览
简要总结
This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •be at least 18 years of age
- •sign an informed consent form and be given a copy
- •be in good general health as determined by the Investigator/designee
- •agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
- •agree to not participate in any other oral care study for the duration of this study
- •agree to return for scheduled visits and follow all study procedures
- •have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge
排除标准
- •severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- •active treatment for periodontitis
- •any diseases or conditions that might interfere with the subject safely completing the study
- •inability to undergo study procedures
- •fixed facial orthodontic appliances
- •a history of kidney stones
- •self-reported pregnancy or nursing
- •known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
研究组 & 干预措施
Colgate® Sensitivity Relief Pen
Active Comparator
Professionally Applied
干预措施: Colgate® Sensitivity Relief Pen (Device)
Crest® Sensi-Stop™ Strips
Active Comparator
Professionally Applied
干预措施: Crest® Sensi-Stop™ Strips (Device)
结局指标
主要结局
Change From Baseline Visual Analog Scale
时间窗: 1 Day
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.
次要结局
- Change From Baseline for Air Challenge(1 Day)
研究者
研究点 (2)
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