GingivitisNCT07691814
Powered Toothbrush Versus Manual Toothbrush on Plaque and Gingivitis After a Six-Week Period of Home Use
A study testing power toothbrush and manual toothbrush in people with Gingivitis, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- power toothbrush and manual toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gingivitis
- Being tested
- power toothbrush, manual toothbrush
- Keywords
- Dental Plaque; Gum health
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
power toothbrushDevice
Sonicare Powered Toothbrush and All-in-One Brush head
manual toothbrushDevice
Colgate Classic Adult manual toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush | Active comparator | Administered using Colgate Classic Adult Manual Toothbrush Receives: Device: manual toothbrush |
| Power Toothbrush | Experimental | Administered using Sonicare Power toothbrush with All-in-One brush head Receives: Device: power toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 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,
- separate flecks of plaque at the cervical margin of the tooth,
- a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth,
- a band of plaque wider than 1 mm covering less than one third of the crown of the tooth,
- plaque covering at least one-third but less than two-thirds of the crown of the tooth,
- 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.
Measured: 6 weeks
Secondary outcomes (5)
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 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,
- separate flecks of plaque at the cervical margin of the tooth,
- a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth,
- a band of plaque wider than 1 mm covering less than one third of the crown of the tooth,
- plaque covering at least one-third but less than two-thirds of the crown of the tooth,
- 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.
Measured: 2 weeks
Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 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,
- mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit,
- mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva,
- moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva,
- 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.
Measured: 2 weeks
Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 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,
- mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit,
- mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva,
- moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva,
- 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.
Measured: 6 weeks
Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 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,
- = bleeding on gently probing,
- = bleeding appears immediately upon gently probing,
- = 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.
Measured: 2 weeks
Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 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,
- = bleeding on gently probing,
- = bleeding appears immediately upon gently probing,
- = 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start5 Oct 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691814
- Sponsor's protocol ID
- OHC_OHC_Xi'an_2020_10863
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data is available upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07691814
- Acronym / sponsor ID
- OHC_OHC_Xi'an_2020_10863
- Conditions
- Gingivitis
- Keywords
- Dental Plaque; Gum health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush | Active comparator | Device: manual toothbrushAdministered using Colgate Classic Adult Manual Toothbrush |
| Power Toothbrush | Experimental | Device: power toothbrushAdministered using Sonicare Power toothbrush with All-in-One brush head |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| power toothbrushSonicare Powered Toothbrush and All-in-One Brush head | Device | Power Toothbrush |
| manual toothbrushColgate Classic Adult manual toothbrush | Device | Manual Toothbrush |
Primary outcome
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
Time frame: 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.
5 secondary outcomes
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks
Time frame: 2 weeks
Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 2 weeks
Time frame: 2 weeks
Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 6 weeks
Time frame: 6 weeks
Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 2 weeks
Time frame: 2 weeks
Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. Data is available upon request
Related trials for Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing power toothbrush and manual toothbrush in people with Gingivitis, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.