A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short 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
- Change From Baseline in Schiff Sensitivity Score on Day 14
研究概览
简要总结
A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing 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, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dentifrice containing stannous fluoride
Toothpaste
干预措施: Stannous Fluoride (Drug)
Dentifrice containing Sodium Monofluorophosphate
Toothpaste
干预措施: Sodium Monofluorophosphate (Drug)
结局指标
主要结局
Change From Baseline in Schiff Sensitivity Score on Day 14
时间窗: Baseline, Day 14
Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
次要结局
- Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14(Baseline, post first brushing (after 5 minutes), Day 3 and Day 14)
- Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3(Baseline, post first brushing (after 5 minutes) and Day 3)