A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
研究概览
简要总结
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who suffer from tooth sensitivity
- •Inclusion Criteria:
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Dentifrice containing stannous fluoride
干预措施: Stannous Fluoride (Drug)
Arm 2
Marketed dentifrice containing Sodium Monofluorophosphate
干预措施: Sodium Monofluorophosphate (Drug)
结局指标
主要结局
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
时间窗: Baseline to 8 weeks post administration of study treatment
Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
次要结局
- Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4(Baseline to 4 weeks post administration of study treatment)
- Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8(Baseline to 8 weeks post administration of study treatment)
- Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4(Baseline to 4 weeks post administration of study treatment)