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Powered Toothbrush Versus Manual Toothbrush on Plaque and Gingivitis After a Six-Week Period of Home Use

2026年7月7日 更新者：Philips Clinical & Medical Affairs Global

A Randomized, Parallel Design Study to Compare the Effects of A New Philips Sonicare Brush Head Versus Manual Toothbrush on Plaque and Gingivitis After a Six-Week Period of Home Use

The goal of this clinical trial is to learn if powered toothbrushing is more effective than manual toothbrushing in removing dental plaque. It will also learn about the safety of power toothbrushing. The main questions the study aims to answer are:

Does power toothbrushing remove more dental plaque than manual toothbrushing? Does power toothbrushing reduce symptoms of gingivitis better than manual toothbrushing?

Participants will:

Brush their teeth twice a day with either a manual or power toothbrush Visit the clinic twice during the study, after two and six weeks after the study starts.

Keep a diary of when they brushed their teeth

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

104

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

  • 美国
    • Indiana
      • Fort Wayne、Indiana、美国、46825
        • Salus Research Inc

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Be willing and physically able to carry out all study procedures and be available at all times required for participation
  • Be able to fully understand and comply with the written and verbal instructions provided
  • Provide written informed consent
  • Willing to attend all study visits
  • Agree to return study materials at the required visit(s)
  • Between the ages of 18-65 years
  • A non-smoker
  • Minimum of 20 'scorable' teeth (excluding 3rd molars)
  • Average plaque score of >1.8 per Modified Plaque Index scoring with 3-6 hours of plaque accumulation
  • Gingival bleeding score of >1 on a minimum of 50 gingival sites per Gingival Bleeding Index
  • Regular manual toothbrush user

Exclusion Criteria:

  • Pregnant or nursing per subject report
  • A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion
  • A medical condition requiring antibiotic pre-medication prior to dental appointments
  • Diagnosis of xerostomia
  • Oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth
  • Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator/Examiner discretion
  • Oral surgery within the last 2 months Currently using professionally dispensed bleaching products
  • A known allergy or sensitivity to products planned for use in this study
  • Unwilling to abstain from all other oral hygiene products other than those prescribed for the duration of the study
  • Participated in an oral care study within the previous 60 days
  • Employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm
  • Dental student or dental professional
  • A cardiac pacemaker or implanted cardiac defibrillator
  • Insulin-Dependent Diabetes
  • Current use of antibiotic medications or use within 4 weeks of enrollment
  • Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily)
  • Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion
  • Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
  • Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion
  • Presence of orthodontic bands, wires or brackets
  • A professional prophylaxis within 4 weeks of the study
  • Regular power toothbrush user

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Manual Toothbrush
Administered using Colgate Classic Adult Manual Toothbrush
设备：manual toothbrush
Colgate Classic Adult manual toothbrush
实验性的：Power Toothbrush
Administered using Sonicare Power toothbrush with All-in-One brush head
设备：power toothbrush
Sonicare Powered Toothbrush and All-in-One Brush head

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
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
大体时间：6 weeks

Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque,

  1. separate flecks of plaque at the cervical margin of the tooth,
  2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth,
  3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth,
  4. plaque covering at least one-third but less than two-thirds of the crown of the tooth,
  5. plaque covering two-thirds or more of the crown of the tooth.

Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups.
6 weeks

次要结果测量

结果测量
措施说明
大体时间
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks
大体时间：2 weeks

Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque,

  1. separate flecks of plaque at the cervical margin of the tooth,
  2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth,
  3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth,
  4. plaque covering at least one-third but less than two-thirds of the crown of the tooth,
  5. plaque covering two-thirds or more of the crown of the tooth.

Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups.
2 weeks
Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 2 weeks
大体时间：2 weeks

Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation,

  1. mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit,
  2. mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva,
  3. moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva,
  4. severe inflammation, marked redness, edema, and/or hypertrophy of the marginal or papillary gingiva, spontaneous bleeding, congestion or ulceration.

Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the manual and power toothbrush groups.
2 weeks
Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 6 weeks
大体时间：6 weeks

Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation,

  1. mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit,
  2. mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva,
  3. moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva,
  4. severe inflammation, marked redness, edema, and/or hypertrophy of the marginal or papillary gingiva, spontaneous bleeding, congestion or ulceration.

Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the manual and power toothbrush groups.
6 weeks
Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 2 weeks
大体时间：2 weeks

Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding,

  1. = bleeding on gently probing,
  2. = bleeding appears immediately upon gently probing,
  3. = spontaneous bleeding which is present prior to probing.

Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the manual and power toothbrush groups.
2 weeks
Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 6 weeks
大体时间：6 weeks

Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding,

  1. = bleeding on gently probing,
  2. = bleeding appears immediately upon gently probing,
  3. = spontaneous bleeding which is present prior to probing.

Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the manual and power toothbrush groups.
6 weeks

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

Philips Clinical & Medical Affairs Global

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)

2020年10月5日

初级完成 (实际的)

2020年11月20日

研究完成 (实际的)

2020年11月20日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • OHC_OHC_Xi'an_2020_10863

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data is available upon request

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

是的

在美国制造并从美国出口的产品

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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