Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 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 assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.
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
- 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, 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 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
- •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 orthodontic appliances
研究组 & 干预措施
Oxalate Salt Solution
Professionally applied
干预措施: Oxalate Salt Solution (Device)
No Treatment
No Treatment
结局指标
主要结局
Change From Baseline Air Challenge
时间窗: 10 Minutes
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. 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 for Yeaple Probe(10 Minutes)