Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush

University of Minnesota (UMN)

Status: Enrolling

Conditions: Toothbrush; Plaque; Gingivitis

Treatments: Device: FMET

Study type: Interventional

Funder types: Other

Identifiers

NCT06561204

STUDY00022906

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

FMET + ADA dentifrice

Experimental group

Description:

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.

Treatment:

Device: FMET

Conventional electronic toothbrush + ADA dentifrice

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: FMET