A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change From Baseline Air Challenge
研究概览
简要总结
This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing 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
- 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 photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
- •be in good general health as determined by the Investigator/designee; and
- •have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air 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;
- •any diseases or conditions that might interfere with the safe completion of the study; or
- •an inability to undergo any study procedures.
研究组 & 干预措施
oxalate liquid, SnF2 paste, manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
干预措施: Potassium Oxalate (Device)
oxalate liquid, SnF2 paste, manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
干预措施: Stannous fluoride paste (Drug)
oxalate liquid, SnF2 paste, manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
干预措施: Manual toothbrush (Device)
oxalate liquid, SnF2 paste, power toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
干预措施: Potassium Oxalate (Device)
oxalate liquid, SnF2 paste, power toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
干预措施: Stannous fluoride paste (Drug)
oxalate liquid, SnF2 paste, power toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
干预措施: Power toothbrush (Device)
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)