Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush

Description

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.

Conditions

Toothbrush, Gingivitis, Plaque

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Study Overview

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Study Details

Study overview

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.

Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: a Randomized Clinical Trial

Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush

Condition
Toothbrush
Intervention / Treatment

-

Contacts and Locations

Minneapolis

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Minnesota,

Michelle C Arnett, MS, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2025-12-01