Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush

Last updated: December 30, 2024
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

FMET

Clinical Study ID

NCT06561204
STUDY00022906
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • University of Minnesota School of Dentistry patient of record who is 18 years of ageor older.

  • Documented periodontal classification of mild to moderate gingivitis (>10% BOP) ordocumented gingivitis on an intact, reduce, or stable with a history ofperiodontitis 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, dentalimplants or teeth with more that ½ of natural surface restored).

  • Be willing to abstain from all professional oral hygiene care (prophy/periodontalmaintenance) 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.) duringthe study.

  • Access to personal email account and a device connected to the internet to completequestionnaires and communicate with study team.

Exclusion

Exclusion Criteria:

  • Presence of aggressive, necrotizing, uncommon periodontal disease, or anyuncontrolled periodontal condition.

  • Presence of any physical limitation or restriction that might preclude normal oralhygiene procedures (i.e. need another individual to perform oral self-care).

  • Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or underorthodontic treatment.

  • Any medication that may impact periodontal conditions (i.e., phenytoin, calciumantagonists, cyclosporin, warfarin, antimicrobials, or steroids).

  • Have any uncontrolled medical condition or immunocompromised that may impact thestudy (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 lastsix weeks.

  • Cigarette use within the last year

  • Unable to comply with the study protocol

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: FMET
Phase:
Study Start date:
December 30, 2024
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • University of Minnesota School of Dentistry

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

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