A Pilot Clinical Study to Evaluate the Safety and Efficacy of a Self-Applied Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change From Baseline Cold Water Challenge
研究概览
简要总结
This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale 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
- •self-reported pregnancy or nursing
- •a history of kidney stones
- •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
Crest® Sensi-Stop™ Strips
Self Applied
干预措施: Crest® Sensi-Stop™ Strips (Device)
结局指标
主要结局
Change From Baseline Cold Water Challenge
时间窗: 1 Day
The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
次要结局
- Change From Baseline Visual Analog Scale(1 Day)