A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
2018年7月26日 更新者：GlaxoSmithKline
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Indiana
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Fort Wayne、Indiana、美国、46825
- GSK Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5
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安慰剂比较：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.
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Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5
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实验性的：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.
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Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5
Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
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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 of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
大体时间：Baseline, Week 8
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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.
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Baseline, Week 8
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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 VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
大体时间：Baseline, Week 8
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Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS.
The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").
A reduction in the score is indicative of an improvement in sensitivity.
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Baseline, Week 8
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Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
大体时间：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.
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Baseline, Week 8
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Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
大体时间：Baseline, Week 4
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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.
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Baseline, Week 4
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Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
大体时间：Baseline, Week 4
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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 has 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 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.
However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g.
For analysis purposes values recorded as >80g were treated as 90g values.
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Baseline, Week 4
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Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
大体时间：Baseline, Week 8
|
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 has 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 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.
However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g.
For analysis purposes values recorded as >80g were treated as 90g values.
|
Baseline, Week 8
|
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Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
大体时间：Baseline, Week 4
|
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS.
The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain).
A reduction in the score is indicative of an improvement in sensitivity.
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Baseline, Week 4
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月8日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月18日
研究注册日期
首次提交
2016年4月25日
首先提交符合 QC 标准的
2016年4月25日
首次发布 (估计)
2016年4月27日
研究记录更新
最后更新发布 (实际的)
2018年8月27日
上次提交的符合 QC 标准的更新
2018年7月26日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Experimental Oral Rinse 1的临床试验
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