A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 4
- 主要终点
- Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
研究概览
简要总结
An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.
详细描述
A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects in good general health with no clinically significant/ relevant abnormalities of oral examination
- •pre-existing self reported and clinically diagnosed tooth sensitivity
- •at screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
- •at baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
排除标准
- •subjects with a known or suspected intolerance or hypersensitivity to study products
- •presence of chronic debilitating disease which could affect study outcomes
- •any condition which is causing dry mouth
- •use of an oral care product indicated for the relief of dentine hypersensitivity
- •participation in a DH treatment study in the 8 weeks prior to screening
- •taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
- •require antibiotic prophylaxis for dental procedures
- •dental prophylaxis within 4 weeks of screening
- •treatment of periodontal disease within 12 months of screening+C60
- •scaling or root planing within 3 months of screening
- •tooth bleaching within 8 weeks of screening
- •active caries or periodontitis
- •partial dentures, orthodontic appliances or dental implants which could affect study outcomes
- •Pregnant and breast-feeding females
- •Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine 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 aetiologies other than erosion, abrasion or recession
结局指标
主要结局
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
时间窗: At Baseline and Week 8
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
次要结局
- Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8(At Baseline, Week 4 and Week 8)
- Change From Baseline in Tactile Threshold at Week 4 and Week 8(At Baseline, Week 4 and Week 8)
- Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4(At Baseline and Week 4)