Effectiveness of Two Water-Based Potassium Oxalate Desensitizers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 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 two water-based potassium oxalate desensitizers on existing 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
- Double (Participant, Investigator)
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
- •Provide written informed consent to participate in the study
- •Be at least 18 years of age
- •Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
- •Agree to refrain from participating in any other oral/dental product studies for the duration of the study
- •Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
- •Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
- •Agree to comply with study/product usage instructions; and
- •Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening
排除标准
- •Gross oral neglect or urgent dental treatment needs
- •Severe periodontal disease and/or generalized mobility
- •Active treatment for periodontitis
- •Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
- •Self-reported pregnancy or nursing
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 Visual Analog Scale(30 Days)