NCT07593755已完成不适用
Comparative Clinical Trial to Evaluate the Efficacy of a Toothpaste in Subjects With Dental Hipersensitivity
Lacer S.A.1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2025年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
研究概览
简要总结
The goal of this study is to learn if a toothpaste alone and together with mouthwash 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 toothpaste help to improve signs of teeth hypersensitivity? Researchers will compare sensitive teeth toothpaste and use of sensitive teeth and mouthwash to a regular toothpaste 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy female and male participants (no specific gender distributions required)
- •Aged 18 years or older
- •Participants presenting dental hyperesthesia with at least two hypersensitive teeth with a verbal rating scale (VRS) score greater than or equal to 1 after tactile stimulation, and a Schiff Cold Air Sensitivity Scale score greater than or equal to 1 at the initial visit (T0).
- •Participants certifying the truthfulness of the personal data disclosed to the investigator.
- •Participants able to understand the language used at the investigation centre and comprehend the information provided by the investigator.
- •Participants able to follow the instructions provided by the investigator and comply with the study requirements and restrictions.
- •Pharmacological therapy (except for therapies listed under non-inclusion criteria) must have been stable for at least one month, with no changes expected or planned during the study
- •Commitment by the participants not to change the daily routine or lifestyle during the study.
- •Participants who have not taken part in any other similar clinical study in the previous six months.
- •Commitment by the participant not to use other oral hygiene products containing fluoride or ingredients such as hydroxyapatite during the study period.
排除标准
- •Participants currently participating or planning to participate in other clinical trials.
- •Participants deprived of liberty by administrative or judicial decision or under guardianship.
- •Participants who cannot be contacted in the event of an emergency.
- •Participants admitted to a healthcare or social institution.
- •Participants planning hospitalization during the study period.
- •Participants who have taken part in a similar study without respecting an adequate washout period (defined as the use of desensitizing agents within the last six months).
- •Participants under pharmacological treatments that modify the evaluation of dental sensitivity or are incompatible with the requirements of the study.
- •Participants with a history of active caries within the past 12 months or at risk for developing caries (e.g., multiple dental restorations, crowns with compromised margins) per examiners discretion.
- •Participants with known allergies or sensitivities to any components of the investigational product.
- •Women who are breastfeeding, pregnant, or unwilling to take the adequate contraceptive measures to avoid pregnancy during the study (for women of childbearing potential).
- •Participants with acute, chronic, or progressive pathologies (including diabetes, cardiovascular and metabolic conditions) incompatible with the study requirements.
- •Any tooth surface adjacent to those surfaces under investigation that in the opinion of the investigator have any other condition that produce symptoms confounding the evaluation of cervical dentin hypersensitivity.
- •Participants with a medical history or taking medication, or wearing physical items (e.g., orthodontic braces) that could interfere with the study.
- •Participants with a history of illegal drug use.
研究者
研究点 (1)
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