ToothbrushNCT06561204
Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush
A study testing FMET in people with Toothbrush and Gingivitis, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Toothbrush, Gingivitis, Plaque
- What is being tested?
- FMET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to 10 Oct 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Minnesota School of Dentistry patient of record who is 18 years of age or older.
- Documented periodontal classification of mild to moderate gingivitis (>10% BOP) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in AxiUm electronic health record (EHR) >10% BOP.
- A minimum of 25% plaque measured O'Leary plaque score.
- A minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored).
- Be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study.
- Be willing to abstain from the use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.) during the study.
- Access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team.
Who cannot join
- Presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition.
- Presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care).
- Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment.
- Any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids).
- Have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes HbA1c > 7, HIV).
- Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
Show all 9Show fewer
- ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
- Cigarette use within the last year
- Unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota School of Dentistry
Minneapolis, Minnesota, 55455
About this study
Official title: Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: A Randomized Clinical Trial
The goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.
Read the detailed description
The primary purpose is to compare the FMET + ADA dentifrice to the conventional ETB + ADA dentifrice. The exploratory aim is to compare the FMET + foam system to both the FMET + ADA dentifrice and conventional ETB + ADA dentifrice. Baseline and 30-day outcome measures will be collected to evaluate the impact on clinical indicators of gingivitis, plaque, and patient perceptions.
- Conditions
- Toothbrush, Gingivitis, Plaque
- Being tested
- FMET
- 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.
FMETDevice
A full-mouth electronic toothbrush
| Study group | Role | What they receive |
|---|---|---|
| FMET + ADA dentifrice | Experimental | Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions. Receives: Device: FMET |
| Conventional electronic toothbrush + ADA dentifrice | No intervention | Baseline and 30-day outcome measures will be collected to evaluate the impact of conventional electronic toothbrush + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions. |
| FMET + Foam | Other | Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + foam on clinical indicators of gingivitis, plaque, and patient perceptions. Receives: Device: FMET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Löe & Silness gingival index (GI)
Scale 0-3
Measured: Baseline and 30-days
Turesky modification of the Quigley-Hein index
Scale 0-5
Measured: Baseline and 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start30 Dec 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToothbrushStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- FENO.Co
- Responsible party
- Sponsor
- Investigators
- Michelle C Arnett, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561204
- Sponsor's protocol ID
- STUDY00022906
- Status last verified
- Dec 2025
- First submitted
- 16 Aug 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06561204
- Acronym / sponsor ID
- STUDY00022906
- Conditions
- Toothbrush, Gingivitis, Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- FENO.Co
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 19 Aug 2024 (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 randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.
Detailed description
The primary purpose is to compare the FMET + ADA dentifrice to the conventional ETB + ADA dentifrice. The exploratory aim is to compare the FMET + foam system to both the FMET + ADA dentifrice and conventional ETB + ADA dentifrice. Baseline and 30-day outcome measures will be collected to evaluate the impact on clinical indicators of gingivitis, plaque, and patient perceptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMET + ADA dentifrice | Experimental | Device: FMETBaseline and 30-day outcome measures will be collected to evaluate the impact of FMET + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions. |
| Conventional electronic toothbrush + ADA dentifrice | No intervention | –Baseline and 30-day outcome measures will be collected to evaluate the impact of conventional electronic toothbrush + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions. |
| FMET + Foam | Other | Device: FMETBaseline and 30-day outcome measures will be collected to evaluate the impact of FMET + foam on clinical indicators of gingivitis, plaque, and patient perceptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- University of Minnesota School of Dentistry patient of record who is 18 years of age or older.
- Documented periodontal classification of mild to moderate gingivitis (>10% BOP) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in AxiUm electronic health record (EHR) >10% BOP.
- A minimum of 25% plaque measured O'Leary plaque score.
- A minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored).
- Be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study.
Key exclusion criteria (9 listed)
- Presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition.
- Presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care).
- Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment.
- Any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids).
- Have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes HbA1c > 7, HIV).
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 |
|---|---|---|
| FMETA full-mouth electronic toothbrush | Device | FMET + ADA dentifrice, FMET + Foam |
Primary outcome
Löe & Silness gingival index (GI)
Time frame: Baseline and 30-days
Scale 0-3
Turesky modification of the Quigley-Hein index
Time frame: Baseline and 30-days
Scale 0-5
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 17 Dec 2025.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers.
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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.
Michelle C Arnett, MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMET in people with Toothbrush and Gingivitis, run by University of Minnesota 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 7 inclusion and 9 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 17 Dec 2025. 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?
Löe & Silness gingival index (GI) (time frame: Baseline and 30-days). 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 17 Dec 2025.