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
- 119
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Schiff Sensitivity Score
研究概览
简要总结
Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
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
- •Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
- •Participants with minimum of 20 natural teeth.
- •At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.
- •Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- •Teeth with Gingival Index score ≤1 and a clinical mobility of ≤
- •Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.
排除标准
- •Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- •Any condition which, in the opinion of the investigator, causes dry mouth.
- •Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
- •Participant using of a desensitising dentifrice within 6 weeks of screening
研究组 & 干预措施
0.454% stannous fluoride dentifrice
Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water.
干预措施: Stannous fluoride (Drug)
0.76% sodium monofluorophosphate dentifrice
Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
干预措施: Sodium monofluorophosphate (Drug)
结局指标
主要结局
Mean Change From Baseline in Schiff Sensitivity Score
时间窗: Baseline-Week 8
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
次要结局
- Mean Change From Baseline in Tactile Sensitivity(Baseline-Week 4)
- Mean Change From Baseline in Schiff Sensitivity Score(Baseline-Week 4)
- Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)(Baseline-Week 4)
- Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)(Baseline - Week 8)