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Search / Trial NCT06561204

Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush

Launched by UNIVERSITY OF MINNESOTA · Aug 16, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a new type of toothbrush called a full-mouth electronic toothbrush (FMET) in comparison to a conventional electronic toothbrush. The study aims to see which toothbrush helps reduce gingivitis (gum inflammation) and plaque buildup. Participants will be divided into three groups: one using the FMET with an approved toothpaste, another using a regular electronic toothbrush with the same toothpaste, and a third group using the FMET with a foam cleaning system.

To participate, you need to be at least 18 years old and a patient at the University of Minnesota School of Dentistry with mild to moderate gum disease and noticeable plaque on your teeth. You should have at least five natural teeth in each quadrant of your mouth. During the study, you will need to refrain from any professional dental cleanings or other dental aids like floss or mouthwash. Participants will be asked to complete questionnaires online, so having an email account and internet access is important. If you have certain health conditions or are currently using specific medications, you may not be eligible for this trial. This study is currently recruiting participants, and your involvement could help improve oral health care for many people.

Gender

ALL

Eligibility criteria

  • 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

About University Of Minnesota

The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.

Locations

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Michelle C Arnett, MS

Principal Investigator

University of Minnesota

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported