GingiviitsNCT07813546
Comparion of Effects of Two Different Power Toothbrushes on Plaque and Gum Health
A study testing oscillating-rotating powered toothbrush and side-to-side powered toothbrush in people with Gingiviits, 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 with a side-to-side motion is more effective than powered toothbrushing with oscillating-rotation motion in removing dental plaque. It will also learn about the safety of power toothbrushing with both products. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingiviits
- What is being tested?
- oscillating-rotating powered toothbrush and side-to-side powered toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 28 Jul 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be in general good health
- 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
- Be willing to attend all study visits
- Agree to return study materials at the required visit(s)
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- Between the ages of 18-59 years
- Be a non-smoker
- Have a minimum of 20 'scorable' teeth (excluding 3rd molars)
- Have an average plaque score of >1.8 per Modified Plaque Index scoring with 3-6 hours of plaque accumulation
- Have a gingival bleeding score of >1 on a minimum of 50 gingival sites per Gingival Bleeding Index
- Be a regular manual toothbrush user
Who cannot join
- Are 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
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- 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
- Immunocompromised or Immune-impaired/suppressed.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Six-Week Randomized, Parallel Design Study to Compare the Effects of Philips Sonicare 9900 Prestige Versus an Oscillating-Rotating Power Toothbrush on Plaque and Gum Health
The goal of this clinical trial is to learn if powered toothbrushing with a side-to-side motion is more effective than powered toothbrushing with oscillating-rotation motion in removing dental plaque. It will also learn about the safety of power toothbrushing with both products. The main questions the study aims to answer are:
Does side-to-side power toothbrushing remove more dental plaque than oscillating-rotation toothbrushing? Does side-to-side power toothbrushing reduce symptoms of gingivitis better than oscillating-rotation toothbrushing?
Read more
Participants will:
Brush their teeth twice a day with either a side-to-side or oscillating-rotation power toothbrush Visit the clinic twice during the study: once at baseline and six weeks after the study starts.
Keep a diary of when they brushed their teeth
- Conditions
- Gingiviits
- Being tested
- oscillating-rotating powered toothbrush, side-to-side powered toothbrush
- Keywords
- dental plaque, gum health
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oscillating-rotating powered toothbrushDevice
Oral-B iO Series 9
side-to-side powered toothbrushDevice
Sonicare 9900 Prestige
| Study group | Role | What they receive |
|---|---|---|
| oscillating-rotating powered toothbrush | Active comparator | Not described Receives: Device: oscillating-rotating powered toothbrush |
| side-to-side powered toothbrush | Experimental | Not described Receives: Device: side-to-side powered toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the reduction in gingival inflammation for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
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 two powered toothbrush groups.
Measured: 6 weeks
Secondary outcomes (2)
Compare the reduction in gingival bleeding for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
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 two powered toothbrush groups.
Measured: 6 weeks
Compare the reduction in surface plaque for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
Surface plaque is 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 two powered 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 posted10 Sep 2026
- Study start24 May 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingiviitsStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- 295 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
- NCT07813546
- Sponsor's protocol ID
- OHC_Xian PDLM H2H_2021_11234
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data is available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-Week Randomized, Parallel Design Study to Compare the Effects of Philips Sonicare 9900 Prestige Versus an Oscillating-Rotating Power Toothbrush on Plaque and Gum Health
- ClinicalTrials.gov ID
- NCT07813546
- Acronym / sponsor ID
- OHC_Xian PDLM H2H_2021_11234
- Conditions
- Gingiviits
- Keywords
- dental plaque, gum health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 10 Sep 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 with a side-to-side motion is more effective than powered toothbrushing with oscillating-rotation motion in removing dental plaque. It will also learn about the safety of power toothbrushing with both products. The main questions the study aims to answer are:
Does side-to-side power toothbrushing remove more dental plaque than oscillating-rotation toothbrushing? Does side-to-side power toothbrushing reduce symptoms of gingivitis better than oscillating-rotation toothbrushing?
Participants will:
Brush their teeth twice a day with either a side-to-side or oscillating-rotation power toothbrush Visit the clinic twice during the study: once at baseline 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 |
|---|---|---|
| oscillating-rotating powered toothbrush | Active comparator | Device: oscillating-rotating powered toothbrush |
| side-to-side powered toothbrush | Experimental | Device: side-to-side powered toothbrush |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Be in general good health
- 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
- Be willing to attend all study visits
Key exclusion criteria (23 listed)
- Are 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 |
|---|---|---|
| oscillating-rotating powered toothbrushOral-B iO Series 9 | Device | oscillating-rotating powered toothbrush |
| side-to-side powered toothbrushSonicare 9900 Prestige | Device | side-to-side powered toothbrush |
Primary outcome
Compare the reduction in gingival inflammation for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
Time frame: 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 two powered toothbrush groups.
2 secondary outcomes
Compare the reduction in gingival bleeding for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
Time frame: 6 weeks
Compare the reduction in surface plaque for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Data is available upon reasonable request
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 oscillating-rotating powered toothbrush and side-to-side powered toothbrush in people with Gingiviits, 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 12 inclusion and 23 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 10 Sep 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 gingival inflammation for side-to-side powered toothbrush to oscillating-rotating powered toothbrush. (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 10 Sep 2026.