Status:
COMPLETED
Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
FENO.Co
Conditions:
Toothbrush
Gingivitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 dentif...
Detailed 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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06561204
Start Date
December 30 2024
End Date
October 10 2025
Last Update
December 17 2025
Active Locations (1)
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1
University of Minnesota School of Dentistry
Minneapolis, Minnesota, United States, 55455