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Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes

2026年11月2日 更新者:Mehtap Bilgin Çetin、Baskent University

This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Participants also evaluated their experience with each mouthwash using a questionnaire.

研究概览

详细说明

This single-center, randomized controlled crossover study compared mouthwashes containing 0.02% hypochlorous acid (HOCl) and 0.2% chlorhexidine (CHX) using a four-day plaque regrowth model. Thirty participants were enrolled, and 26 completed both treatment periods.

Each mouthwash was used twice daily, with 10 mL rinsed for one minute, during a four-day period. The treatment periods were separated by a 14-day washout period. Professional prophylaxis was performed at the beginning of each treatment period. Participants refrained from toothbrushing and interdental cleaning during the treatment periods.

Clinical assessments included the Modified Plaque Index, bleeding on probing, and the Modified Stain Index. Supragingival plaque samples were collected at the end of each treatment period for microbiological analysis, including bacterial colony counts and identification by MALDI-TOF mass spectrometry. Participants completed a questionnaire evaluating their experience with each mouthwash and indicated their final preference.

研究类型

介入性

注册 (实际的)

30

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

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 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Systemically healthy.
  • Aged 18-65 years.
  • Having at least 22 natural teeth.
  • Nonsmoker.
  • Willing to abstain from alcohol throughout the study.

Exclusion Criteria:

  • Presence of periodontitis or gingivitis.
  • Pregnancy or breastfeeding.
  • Use of medications that may affect periodontal status.
  • Antibiotic or anti-inflammatory medication use within the previous six months.
  • Use of antimicrobial mouth rinses, gels, or chewing gums within the previous three months.
  • Known allergy to any component of the study mouth rinses.
  • Presence of tongue conditions, such as geographic tongue or hairy tongue.
  • Periodontal probing depths of 4 mm or greater.
  • Gingival recession of 2 mm or greater.
  • Use of fixed or removable dental prostheses, including single crowns, or orthodontic appliances.

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:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:HOCl followed by CHX

Participants used 0.02% hypochlorous acid mouthwash for four days, followed by a 14-day washout period, and then 0.2% chlorhexidine gluconate mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute.

Rinse with 10 mL for one minute, twice daily for four days.

Rinse with 10 mL for one minute, twice daily for four days.

实验性的:CHX followed by HOCl

Participants used 0.2% chlorhexidine gluconate mouthwash for four days, followed by a 14-day washout period, and then 0.02% hypochlorous acid mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute.

Rinse with 10 mL for one minute, twice daily for four days.

Rinse with 10 mL for one minute, twice daily for four 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
Modified Plaque Index
大体时间:At the end of each four-day treatment period.

Dental plaque was assessed using the modified Silness and Löe Plaque Index at six sites per tooth. Each site was scored from 0 (no plaque) to 3 (abundant plaque). Mean scores were calculated for the full mouth and 12 anatomical regions and compared between the HOCl and CHX treatment periods. Mean scores range from 0 to 3; higher scores indicate greater plaque accumulation.

At the end of each four-day treatment period.

次要结果测量

结果测量
措施说明
大体时间
Total culturable bacterial count in supragingival plaque
大体时间:At the end of each four-day treatment period.

Total culturable bacterial counts were measured in supragingival plaque samples collected from molar teeth and expressed as colony-forming units per milliliter (CFU/mL). Counts were compared between the HOCl and CHX treatment periods.

At the end of each four-day treatment period.
Bleeding on Probing (BOP)
大体时间:At the end of each four-day treatment period.

Bleeding was assessed at six sites per tooth using a periodontal probe. Sites showing bleeding within 30 seconds after probing were recorded as positive. BOP was calculated as the number of bleeding sites divided by the total number of examined sites, multiplied by 100. Full-mouth and regional percentages were calculated. Scores range from 0% to 100%; higher values indicate more gingival bleeding.

At the end of each four-day treatment period.
Modified Stain Index (MSI)
大体时间:At the end of each four-day treatment period.

Extrinsic tooth staining was assessed in four regions on each buccal and lingual/palatal tooth surface. Intensity was scored from 0 to 3. Area was scored from 1 to 3 only when intensity was 2 or 3, using the region-specific criteria of Macpherson et al. (2000). For intensity scores of 1, the intensity × area value was defined as 1. The participant-level MSI was calculated by averaging these values across examined regions, with a range of 0-9. Higher scores indicate greater staining.

At the end of each four-day treatment period.

其他结果措施

结果测量
措施说明
大体时间
Participant-reported experience with mouthwashes
大体时间:At the end of each four-day treatment period.

At the end of each treatment period, participants completed a five-item questionnaire assessing mouthwash taste, effects on taste perception, perceived tooth cleanliness, perceived tooth discoloration, and nausea associated with mouthwash use. Each item was rated as 1 (poor), 2 (moderate), or 3 (good). Higher scores indicate a more favorable participant rating. Each item was evaluated separately.

At the end of each four-day treatment period.
Final mouthwash preference
大体时间:After completion of both four-day treatment periods and the intervening 14-day washout period.

After completing both treatment periods, participants indicated which of the two mouthwashes they preferred. The number of participants preferring each mouthwash was recorded.

After completion of both four-day treatment periods and the intervening 14-day washout period.

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。

调查人员

  • 首席研究员:Mehtap Bilgin Cetin, Associate Professor、Baskent University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2022年3月28日

初级完成 (实际的)

2022年4月19日

研究完成 (实际的)

2022年4月19日

研究注册日期

首次提交

2024年8月29日

首先提交符合 QC 标准的

2024年9月5日

首次发布 (实际的)

2024年9月19日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11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)?

未定

IPD 计划说明

A decision regarding sharing individual participant data has not yet been made.

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

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