NCT07596797已完成不适用
Evaluation of the Efficacy of a Product for Oral Care in Use Test Under Dentist Control.
Lacer S.A.1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年7月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change from Baseline in teeth sensitivity to cold air at 14 days.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Desensitizing tooth gel
Experimental
干预措施: Desensitizing tooth gel (Other)
结局指标
主要结局
Change from Baseline in teeth sensitivity to cold air at 14 days.
时间窗: 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.
Change from Baseline in teeth sensitivity to periodontal probe at 14 days
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
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