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

2026년 7월 7일 업데이트: 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

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

104

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Indiana
      • Fort Wayne, Indiana, 미국, 46825
        • Salus Research Inc

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Manual Toothbrush
Administered using Colgate Classic Adult Manual Toothbrush
장치: manual toothbrush
Colgate Classic Adult manual toothbrush
실험적: Power Toothbrush
Administered using Sonicare Power toothbrush with All-in-One brush head
장치: power toothbrush
Sonicare Powered Toothbrush and All-in-One Brush head

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Philips Clinical & Medical Affairs Global

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 10월 5일

기본 완료 (실제)

2020년 11월 20일

연구 완료 (실제)

2020년 11월 20일

연구 등록 날짜

최초 제출

2026년 6월 5일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • OHC_OHC_Xi'an_2020_10863

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Data is available upon request

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다