Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush
NCT ID: NCT06561204
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2024-12-30
2025-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FMET + ADA dentifrice
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.
FMET
A full-mouth electronic toothbrush
Conventional electronic toothbrush + ADA dentifrice
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.
No interventions assigned to this group
FMET + Foam
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.
FMET
A full-mouth electronic toothbrush
Interventions
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FMET
A full-mouth electronic toothbrush
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
* ≥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
18 Years
ALL
Yes
Sponsors
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FENO.Co
UNKNOWN
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Michelle C Arnett, MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota School of Dentistry
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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STUDY00022906
Identifier Type: -
Identifier Source: org_study_id