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Completed

NCT Number: NCT06561204

Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMET

Device

A full-mouth electronic toothbrush

Primary outcomes

  1. Löe & Silness gingival index (GI)

    Time frame: Baseline and 30-days

    Scale 0-3

  2. Turesky modification of the Quigley-Hein index

    Time frame: Baseline and 30-days

    Scale 0-5

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • FENO.Co

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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