A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Schiff Sensitivity Score at Week 8
研究概览
简要总结
The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in good general health, 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 four, non-adjacent teeth.
- •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 participant 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.
- •In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.
研究组 & 干预措施
Potassium nitrate and sodium fluoride
3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride
干预措施: Potassium nitrate and sodium fluoride (Drug)
Standard fluoride dentifrice
Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
干预措施: Standard fluoride dentifrice (Drug)
结局指标
主要结局
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
时间窗: Baseline to 8 week
The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity.
次要结局
- Mean Change From Baseline in Schiff Sensitivity Score at Week 4(Baseline to 4 week)
- Mean Change From Baseline in Tactile Threshold at Week 8(Baseline to 8 week)
- Mean Change From Baseline in Tactile Threshold at Week 4(Baseline to 4 week)
- Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8(Baseline to 8 week)
- Mean Change From Baseline in VRS at Week 4(Baseline to 4 week)