GingivitisNCT04017507
The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health
An observational study of Gingivitis and Plaque, run by Procter and Gamble at 1 site in United States.
Trial summary
The aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Plaque
- What is being tested?
- Oscillating-rotating electric toothbrush, Side-to-side electric toothbrush and Manual toothbrush
- Type of treatment
- Medical device
- How many people
- 2,145 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 30 Nov 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This meta-analysis includes healthy adult male and females.
Subjects were excluded from this study for the following reasons;
- pregnancy,
- rampant caries,
- severe periodontitis,
- at discretionary of the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple P&G Investigation Clinical Sites
Cincinnati, Ohio, 45040
About this study
Official title: The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health: A Meta-Analysis
The aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses.
- Conditions
- Gingivitis, Plaque
- Being tested
- Oscillating-rotating electric toothbrush, Side-to-side electric toothbrush, Manual toothbrush
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillating-rotating electric toothbrushDevice
Oscillating-rotating electric toothbrush used twice daily
Side-to-side electric toothbrushDevice
Side-to-side electric toothbrush used twice daily
Manual toothbrushDevice
Manual toothbrush used twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oscillating-rotating electric toothbrush | Twice daily brushing Receives: Device: Oscillating-rotating electric toothbrush | |
| Side-to-side electric toothbrush | Twice daily brushing Receives: Device: Side-to-side electric toothbrush | |
| Manual toothbrush | Twice daily brushing Receives: Device: Manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bleeding Sites
Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Papillary bleeding index or Mazza gingival index).
Measured: Up to 12 weeks
Dental Plaque Scores
Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index).
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start8 Jan 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017507
- Sponsor's protocol ID
- 2019BrushMetaAnalysis
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health: A Meta-Analysis
- ClinicalTrials.gov ID
- NCT04017507
- Acronym / sponsor ID
- 2019BrushMetaAnalysis
- Conditions
- Gingivitis, Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,145 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Jul 2019 (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 aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oscillating-rotating electric toothbrush | – | Device: Oscillating-rotating electric toothbrushTwice daily brushing |
| Side-to-side electric toothbrush | – | Device: Side-to-side electric toothbrushTwice daily brushing |
| Manual toothbrush | – | Device: Manual toothbrushTwice daily brushing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This meta-analysis includes healthy adult male and females.
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 electric toothbrushOscillating-rotating electric toothbrush used twice daily | Device | Oscillating-rotating electric toothbrush |
| Side-to-side electric toothbrushSide-to-side electric toothbrush used twice daily | Device | Side-to-side electric toothbrush |
| Manual toothbrushManual toothbrush used twice daily | Device | Manual toothbrush |
Primary outcome
Number of Bleeding Sites
Time frame: Up to 12 weeks
Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Papillary bleeding index or Mazza gingival index).
Dental Plaque Scores
Time frame: Up to 12 weeks
Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index).
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 15 Aug 2019.
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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?
An observational study of Gingivitis and Plaque, run by Procter and Gamble 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?
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 15 Aug 2019. 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?
Number of Bleeding Sites (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 15 Aug 2019.