评估测试牙膏缓解牙本质过敏症有效性的研究
2026年4月21日 更新者：HALEON
评估两种封闭技术牙膏缓解牙本质过敏疗效的研究
本研究的目的是通过测量12周每日两次刷牙后蒸发空气敏感性，比较试验性含氟牙膏与标准含氟牙膏在减轻牙本质敏感（DH）方面的临床疗效。
研究概览
详细说明
一项随机、检查者盲、三治疗臂、平行组设计的研究，治疗期为12周。
大约将筛选275名参与者，以确保约120名参与者被随机分组（每组约40名）和至少114名参与者完成研究（每组约38名）。
研究类型
介入性
注册 (实际的)
120
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
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- School and Hospital of Stomatology, Wuhan University
-
-
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
- 成人
接受健康志愿者
是的
描述
纳入标准：
- 参与者理解研究并愿意参与，表现为自愿签署书面知情同意书，并已收到签署并注明日期的知情同意书副本。
- 参与者年龄在18至60岁之间。
- 参与者理解并愿意、能够并可能遵守所有研究程序和限制。
研究者或医学资格指定人员认为参与者具有良好的总体和心理健康状况：
- 无临床显著和相关性的病史或身体/口腔检查异常。
- 不存在任何可能影响参与者安全或健康，或影响参与者理解和遵循研究程序及要求的情况。
- 自述有持续超过6个月但不超过10年的牙齿敏感（DH）病史，且至少有20颗天然牙齿。
排除标准：
- 已知在研究期间怀孕或计划怀孕的女性参与者。
- 正在哺乳的女性参与者。
- 已知或疑似对研究材料（或密切相关的化合物）或其任何声明成分不耐受或过敏的参与者。
- 在筛选访视前30天内参与另一项临床研究或接受研究药物。
- 在筛选访视前8周内接受过牙齿脱敏治疗的参与者（专业敏感治疗和非牙膏类敏感治疗）。
- 曾参与过本研究的参与者。
- 近期（过去一年内）有酒精或其他物质滥用史的参与者。
- 参与者是赞助商或研究中心的员工或其直系亲属。
- 存在慢性衰弱性疾病，研究者认为可能影响研究结果的参与者。
- 存在任何情况或每日服用药物，研究者认为会导致口干症的参与者。
- 在筛选前4周内接受过牙齿洁治的参与者。
- 有舌或唇穿孔或存在牙种植体的参与者。
- 有严重牙周病、筛选前12个月内接受过牙周病治疗（包括手术）、筛选前3个月内接受过洁治或根面平整的参与者。
- 在筛选前8周内进行过牙齿美白的参与者。
测试牙齿有特定牙列排除情况的参与者：
- 牙齿有当前或近期龋齿证据，或报告在筛选前12个月内接受过龋齿治疗。
- 暴露牙本质但伴有深、缺损或面部修复体的牙齿，用作固定或可摘局部义齿基牙的牙齿，有全冠或贴面的牙齿，正畸带环或牙釉质裂纹的牙齿。敏感牙齿的病因除牙本质暴露的侵蚀、磨损或退缩外还有其他因素。
- 研究者认为敏感牙齿预计不会对非处方牙膏治疗产生反应。
- 在筛选前8周内使用过敏感牙膏产品的参与者。
- 每日服用药物或传统草药成分或治疗，研究者认为可能干扰疼痛感知的参与者。此类药物的例子包括镇痛药、抗惊厥药、引起明显或中度镇静的抗组胺药、镇静剂、安定剂、情绪改变药物和抗炎药。草药成分/治疗的例子包括丁香油、橄榄油或其他直接应用于口腔治疗口腔健康问题的治疗。
- 当前正在服用抗生素疗程或在基线前2周内服用过抗生素疗程的参与者。
- 接受过牙科手术或需要抗生素预防牙科手术的参与者。
- 研究者认为不应参与研究的任何参与者。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：测试型牙膏
参与者将被指导在分配的牙刷头部涂抹一条完整的测试牙膏，并在为期12周的治疗期间每天刷牙两次，每次定时1分钟。
|
含有一氟磷酸钠形式1450 ppm（百万分之1450）氟化物的洁齿剂。
|
|
有源比较器：对照牙膏
参与者将被指导使用一条完整的对照牙膏覆盖指定牙刷的刷头，并在12周的治疗期间每天定时刷牙两次，每次1分钟。
|
一种市售的洁齿剂。
|
|
有源比较器：阴性对照牙膏
在整个12周的治疗期间，参与者将被指示将一条完整的阴性对照牙膏涂抹在指定牙刷的刷头上，并每天刷牙两次，每次定时1分钟。
|
一种市售的牙膏。
|
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 |
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice)
大体时间：Baseline and Week 12
|
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant.
After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0 equal to (=) no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus.
Lower score indicated improvement.
Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoint.
|
Baseline and Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)
大体时间：Baseline, Weeks 2, 4, and 8
|
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant.
After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus.
Lower score indicated improvement.
Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
|
Baseline, Weeks 2, 4, and 8
|
|
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe.
Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable).
Higher score indicated worse outcome (higher sensitivity).
Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe).
After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response).
The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (grams [g]).
Higher tactile threshold indicated a better outcome (less sensitivity).
Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant.
After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus.
Lower score indicated improvement.
Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe.
Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable).
Higher score indicated worse outcome (higher sensitivity).
Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe).
After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response).
The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g).
Higher tactile threshold indicated better outcome (less sensitivity).
Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant.
After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus.
Lower score indicated improvement.
Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe.
Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable).
Higher score indicated worse outcome (higher sensitivity).
Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
大体时间：Baseline, Weeks 2, 4, 8 and 12
|
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe).
After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response).
The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g).
Higher tactile threshold indicated better outcome (less sensitivity).
Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
|
Baseline, Weeks 2, 4, 8 and 12
|
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。
赞助
调查人员
- 首席研究员：Minquan Du, DSS, PhD、Wuhan University
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 (实际的)
2013年1月20日
初级完成 (实际的)
2013年6月8日
研究完成 (实际的)
2013年6月8日
研究注册日期
首次提交
2025年12月19日
首先提交符合 QC 标准的
2025年12月19日
首次发布 (实际的)
2026年1月5日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年4月21日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
为进行进一步研究，可向 ww.clinical-trial-register@haleon.com 申请匿名化个体参与者数据和研究文件。
IPD 共享时间框架
IPD将在发布研究主要终点、关键次要终点和安全性数据结果的6个月内提供。
IPD 共享访问标准
在提交研究提案并获得独立审查小组批准以及签署数据共享协议后，即可获得访问权限。访问权限初始期限为12个月，但经合理理由申请，可延长至多另外12个月。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
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