Evaluation of the Mouthwash Effect on Maintaining Healthy Microbiome in Healthy Mouth.
2026年9月22日 更新者:Lacer S.A.
Evaluation of the Efficacy of a Mouthwash in Balancing Oral pH and Maintaining a Healthy Oral Microbiome.
The goal of this study is to learn if mouthwash works to maintain healthy microbiome in subjects with healthy mouth. It will also learn about its safety. The main question it aims to answer is:
• Does the mouthwash helps to maintain healthy microbiome in balance?
Participants will:
- Use mouthwash twice a day for 2 months
- Visit the clinic as scheduled per protocol for evaluations
研究概览
研究类型
介入性
注册 (估计的)
40
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。
学习联系方式
- 姓名:Ruggeri
- 电话号码:+39 02 99025138
- 邮箱:federica.ruggeri@complifegroup.com
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:
- Healthy female and male subjects (without any specific repartition) subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 18 and 55 years (extremes included)
- Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
- Subjects with baseline plaque index PCR ≥ 30% of surfaces with plaque according to O'Leary*
- Subjects with ≥ 20 natural teeth and regular consumption of dietary sugars, including soft drinks, fruit juices, and other sugar-rich foods or beverages.
- Subjects registered with the national public health system in the country where the study is conducted
- Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
- Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
- Subjects who commit not to change their daily routine or lifestyle during the study
- Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
- Subjects informed about the test procedures who have signed a consent form and privacy agreement
Exclusion Criteria:
- Subjects who do not meet the inclusion criteria
- Subjects with active dental caries
- Subjects with acute or chronic diseases (e.g. diabetes) able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements;
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
- Subjects admitted to a health or social facility
- Subjects planning a hospitalisation during the study
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects under pharmacological treatments that are considered incompatible (e.g. antibiotics use 3 months before the study start) with the study requirement by the investigator
- Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
- Subjects who are unwilling to use only the oral health and hygiene products provided as part of the study.
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:mouthwash
|
Mouthwash will be used twice daily for 2 months |
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 |
|---|---|---|
|
Evolution from Baseline in the microbiome at 2 Months.
大体时间:From enrollment to the end of study at 2 months
|
Microbiome evaluation would be done by 16S rRNA gene amplification |
From enrollment to the end of study at 2 months
|
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 (估计的)
2026年10月1日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年9月17日
首先提交符合 QC 标准的
2026年9月22日
首次发布 (实际的)
2026年9月28日
研究记录更新
最后更新发布 (实际的)
2026年9月28日
上次提交的符合 QC 标准的更新
2026年9月22日
最后验证
2026年9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.