Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change From Baseline Air Challenge
研究概览
简要总结
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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;
- •provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •complete a confidentiality disclosure agreement;
- •be in good general health as determined by the Investigator/designee;
- •agree not to participate in any other oral/dental product studies during the course of this study;
- •agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
- •agree to refrain from the use of any non-study oral hygiene products;
- •agree to return for all scheduled visits and follow study procedures; and.
- •have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge
排除标准
- •self-reported pregnancy or nursing;
- •severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- •active treatment of periodontitis;
- •fixed facial orthodontic appliances;
- •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
- •any diseases or conditions that might interfere with the safe completion of the study; or
- •an inability to undergo any study procedures.
结局指标
主要结局
Change From Baseline Air Challenge
时间窗: 30 days
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air 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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
次要结局
- Change From Baseline in Tactile Threshold(30 days)