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 containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, 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
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •Aged between 18 and 55 years inclusive
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- •A. No clinically significant and relevant abnormalities in medical history or upon oral examination.
- •B. Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- •Dental health
- •At Screening:
- •A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
- •B. Good general oral health, with a minimum of 20 natural teeth.
- •C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
- •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 ≤
- •Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
- •At Baseline:
- •D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:
- •Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)
排除标准
- •Pregnant or breast feeding women
- •Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
- •Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
- •Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- •Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
- •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 xerostomia.
- •Treatment of periodontal disease within 12 months of screening
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- •Recent history (within the last year) of alcohol or other substance abuse
- •Dental prophylaxis within four weeks of Screening.
- •Tongue or lip piercing or presence of dental implants.
- •Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
- •Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
- •Teeth bleaching within eight weeks of Screening
- •Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
- •Tooth 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 of exposed dentine.
- •Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator.
- •Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening
- •Individuals who require antibiotic prophylaxis for dental procedures
研究组 & 干预措施
Experimental Oral Rinse1
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 Rinse1
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: Standard 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: Standard 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: Standard 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 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 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 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 Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 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 and 2 and a Placebo Oral Rinse at Week 8(Baseline, Week 8)
- Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 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)