The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Wirral、英国、CH41 6EY
- GSK Investigational Site
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Cheshire
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Ellesmere Port、Cheshire、英国、CH65 4BW
- GSK Investigational Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
- 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 participant'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 ≤1.
- 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)
Exclusion Criteria:
- 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 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.
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:氟化亚锡牙膏
参与者将(在监督下)使用手指将豌豆大小剂量的含有 0.454% w/w 氟化亚锡 (1100ppm) 的实验性洁齿剂直接涂抹在两颗符合条件的牙齿上,并轻轻揉入牙齿的颈部边缘,以分配分配的牙齿时间。
不允许冲洗
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含 0.454% w/w 氟化亚锡 (1100ppm) 的实验性牙粉
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其他:单氟磷酸钠牙粉
参与者将(在监督下)用手指直接涂抹豌豆大小剂量的含 0.76% 单氟磷酸钠(1000ppm 氟化物)的洁齿剂到两颗符合条件的牙齿上,并在分配的时间内轻轻揉入牙齿的颈部边缘.
不允许冲洗。
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含 0.76% 单氟磷酸钠(1000ppm 氟化物)的牙膏
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Schiff Sensitivity Score on Day 3
大体时间:Baseline to 3 days
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The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus.
A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
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Baseline to 3 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
大体时间:Baseline to 60 seconds post first treatment
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The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus.
A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
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Baseline to 60 seconds post first treatment
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Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3
大体时间:Baseline, 60 seconds post first treatment, Day 3
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The examiner assessed the 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 participant whether the sensation caused discomfort.
The pressure setting at which the participant gives 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.
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Baseline, 60 seconds post first treatment, Day 3
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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氟化亚锡牙膏的临床试验
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American College of Radiology - Image MetrixWorld Molecular Imaging Society未知