Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque; Toothbrush
• Intervention / Treatment: Device: FMET

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)
• ≥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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: FMET; A full-mouth electronic toothbrush
No Intervention: 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.
Other: 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.	Device: FMET; A full-mouth electronic toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Löe & Silness gingival index (GI)	Scale 0-3	Baseline and 30-days
Turesky modification of the Quigley-Hein index	Scale 0-5	Baseline and 30-days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: FENO.Co
• Investigators: Principal Investigator: Michelle C Arnett, MS, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Infections; Gingival Diseases; Pathological Conditions, Signs and Symptoms; Plaque, Amyloid; Gingivitis
• Other Study ID Numbers: STUDY00022906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No