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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

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

104

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Indiana
      • Fort Wayne、Indiana、アメリカ、46825
        • Salus Research Inc

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Manual Toothbrush
Administered using Colgate Classic Adult Manual Toothbrush
デバイス：manual toothbrush
Colgate Classic Adult manual toothbrush
実験的：Power Toothbrush
Administered using Sonicare Power toothbrush with All-in-One brush head
デバイス：power toothbrush
Sonicare Powered Toothbrush and All-in-One Brush head

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Philips Clinical & Medical Affairs Global

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年10月5日

一次修了 (実際)

2020年11月20日

研究の完了 (実際)

2020年11月20日

試験登録日

最初に提出

2026年6月5日

QC基準を満たした最初の提出物

2026年7月7日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月9日

QC基準を満たした最後の更新が送信されました

2026年7月7日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • OHC_OHC_Xi'an_2020_10863

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Data is available upon request

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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