A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
研究概览
简要总结
This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
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, 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 no clinically significant/ relevant abnormalities in medical history or upon 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) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
- •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
- •Participants 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
- •Scaling or root planning 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
研究组 & 干预措施
Experimental Oral Rinse 1
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.
干预措施: Experimental Oral Rinse 1 (Device)
Experimental Oral Rinse 1
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.
干预措施: Fluoride toothpaste (Drug)
Experimental Oral Rinse 2
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
干预措施: Experimental Oral Rinse 2 (Device)
Experimental Oral Rinse 2
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
干预措施: Fluoride toothpaste (Drug)
Placebo Oral Rinse
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
干预措施: Placebo Oral Rinse (Other)
Placebo Oral Rinse
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
干预措施: Fluoride toothpaste (Drug)
结局指标
主要结局
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
时间窗: Baseline, Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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 indicate improvement in sensitivity.
次要结局
- Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8(Baseline, Week 8)
- Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4(Baseline, Week 4)
- Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8(Baseline, Week 8)
- Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4(Baseline, Week 4)
- Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4(Baseline, Week 4)
- Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8(Baseline, Week 8)