Evaluation of the Effect of the Gel on Sensitive Teeth
2026年5月18日 更新者:Lacer S.A.
Evaluation of the Efficacy of a Product for Oral Care in Use Test Under Dentist Control.
The goal of this study is to learn if a tooth gel works to alleviate teeth hypersensitivity in adults. It will also learn about the safety of the product.
The main question it aims to answer is:
• Does the tooth gel help to improve signs of teeth hypersensitivity?
Researchers will compare before and after product use to see if it works to improve teeth sensitivity. Participants will:
- Use assigned products daily for 14 days
- Visit the clinic on the established days during 14 days for check-ups and evaluation
研究概览
研究类型
介入性
注册 (实际的)
31
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
-
-
-
Barcelona、西班牙
- CLINICA CIURANA Centre Dental
-
-
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
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Healthy female and male subjects (no specific repartition)
- Aged between 18 years old
- Subjects with dentine hyperesthesia
- Have a minimum of two hypersensitive teeth anterior to non-consecutive molars, with cervical erosion/abrasion or gingival recession, and with a grade greater than or equal to 1 on the verbal rating scale (VRS) after tactile simulation, and greater than or equal to 1 on the Schiff cold air sensitive scale at the beginning of the study.
- Subjects certifying the truthfulness of the personal data disclosed to the investigator
- Subjects able to understand the language used in the investigation canter and the information given by the investigator
- Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- Commitment not to change the daily routine or the lifestyle
- Subjects who have not been recently involved in any other similar study
- Commitment not to use during the study period other products with the same effect of the tested product
- Subjects informed about the test procedures and who have signed a consent form.
Exclusion Criteria:
- Subjects participating or planning to participate in other clinical trials;
- Subjects deprived of liberty by administrative or judicial decision or under guardianship;
- Subjects who cannot be contacted in an emergency;
- Subjects admitted to a health or social center;
- Subjects planning hospitalization during the study;
- Subjects who participated in a similar study without respecting an adequate washout period (used any desensitizing agents during the last three months);
- Subjects who have used anti sensitivity products in the 4 weeks prior to screening;
- Subjects under pharmacological treatments that the investigator considers incompatible with the requirements of the study;
- Subjects who have had active caries within 12 months or who are at risk of caries development (multiple dental restorations, crowns with compromised margin) per examiners discretion;
- Subjects who have shown allergies or sensitivity to any component of the product;
- Subject breastfeeding, pregnant or not willing to take the necessary precautions to avoid pregnancy during the study (for women of childbearing age).
- Any tooth surface adjacent to those surfaces under investigation, which in the opinion of the investigator have any other condition that provides symptoms confusing with those of cervical dentin hypersensitivity.
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:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Desensitizing tooth gel
|
Desensitizing tooth gel was used 3 times a day after meals during 14 days
|
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 |
|---|---|---|
|
Change from Baseline in teeth sensitivity to cold air at 14 days.
大体时间:From enrolment to the end of use at 14 days.
|
Change evaluated by VAS score scale from 0 to 3, where 0 means the absence of pain while 3 is the highest pain.
|
From enrolment to the end of use at 14 days.
|
|
Change from Baseline in teeth sensitivity to periodontal probe at 14 days
大体时间:From enrolment to the end of use at 14 days.
|
Change evaluated by VAS score scale: from 0 to 10, where 0 means the absence of pain while 10 is the highest pain
|
From enrolment to the end of use at 14 days.
|
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
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)
2024年7月8日
初级完成 (实际的)
2024年7月31日
研究完成 (实际的)
2024年7月31日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年5月19日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5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.