A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Median Change From Baseline in Tactile Sensitivity at Week 4
研究概览
简要总结
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
详细描述
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design 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, 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 between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
- •Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.
排除标准
- •Specific Dentition Exclusions for Test teeth
- •Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
- •Tooth with exposed dentin but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentin.
- •Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- •Use of a sensitivity dentifrice within 8 weeks of screening
- •Individuals who require antibiotic prophylaxis for dental procedures
研究组 & 干预措施
5% calcium sodium phosphosilicate/ sodium monofluorophosphate
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
干预措施: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice (Drug)
0% calcium sodium phosphosilicate/sodium monofluorophosphate
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
干预措施: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice (Drug)
Sodium monofluorophosphate
Dentifrice containing 1000 ppmF as sodium monofluorophosphate
干预措施: Sodium monofluorophosphate dentifrice (Drug)
Sodium fluoride
Dentifrice containing 1100 ppmF as sodium fluoride
干预措施: Sodium Fluoride dentifrice (Drug)
结局指标
主要结局
Median Change From Baseline in Tactile Sensitivity at Week 4
时间窗: Baseline and 4 weeks post administration of study treatment
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
时间窗: Baseline and 8 weeks post administration of study treatment
Response to a constant jet of air applied to hypersensitive teeth was 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Mean Change From Baseline in Visual Rating Scale Score at Week 4
时间窗: Baseline and 4 weeks post administration of study treatment
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Median Change From Baseline in Tactile Sensitivity at Week 8
时间窗: Baseline and 8 weeks post administration of study treatment
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
时间窗: Baseline and 4 weeks post administration of study treatment
Response to a constant jet of air applied to hypersensitive teeth was 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Mean Change From Baseline in Visual Rating Scale Score at Week 8
时间窗: Baseline and 8 weeks post administration of study treatment
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
次要结局
- Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4(Baseline and 4 weeks post administration of study treatment)
- Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8(Baseline and 8 weeks post administration of study treatment)