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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

地位

尚未招聘

干预/治疗

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

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:

  1. Healthy female and male subjects (without any specific repartition) subjects
  2. Subjects of Caucasian ethnicity
  3. Subjects aged between 18 and 55 years (extremes included)
  4. Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
  5. Subjects with baseline plaque index PCR ≥ 30% of surfaces with plaque according to O'Leary*
  6. Subjects with ≥ 20 natural teeth and regular consumption of dietary sugars, including soft drinks, fruit juices, and other sugar-rich foods or beverages.
  7. Subjects registered with the national public health system in the country where the study is conducted
  8. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
  9. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
  10. 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
  11. Subjects who commit not to change their daily routine or lifestyle during the study
  12. 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
  13. Subjects informed about the test procedures who have signed a consent form and privacy agreement

Exclusion Criteria:

  1. Subjects who do not meet the inclusion criteria
  2. Subjects with active dental caries
  3. 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;
  4. Subjects participating or planning to participate in other clinical trials
  5. Subjects deprived of freedom by administrative or legal decision or under guardianship
  6. Subjects not able to be contacted in case of emergency
  7. Subjects admitted to a health or social facility
  8. Subjects planning a hospitalisation during the study
  9. Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
  10. 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
  11. 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
  12. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
  13. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
  14. 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

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)?

不

IPD 计划说明

Only data included in the publication will be shared.

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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