Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

7 juli 2026 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

104

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Indiana
      • Fort Wayne, Indiana, Förenta staterna, 46825
        • Salus Research Inc

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Manual Toothbrush
Administered using Colgate Classic Adult Manual Toothbrush
Enhet: manual toothbrush
Colgate Classic Adult manual toothbrush
Experimentell: Power Toothbrush
Administered using Sonicare Power toothbrush with All-in-One brush head
Enhet: power toothbrush
Sonicare Powered Toothbrush and All-in-One Brush head

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Philips Clinical & Medical Affairs Global

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 oktober 2020

Primärt slutförande (Faktisk)

20 november 2020

Avslutad studie (Faktisk)

20 november 2020

Studieregistreringsdatum

Först inskickad

5 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • OHC_OHC_Xi'an_2020_10863

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Data is available upon request

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera