Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush
- Conditions
- GingivitisPlaqueToothbrush
- Interventions
- Device: FMET
- Registration Number
- NCT06561204
- Lead Sponsor
- University of Minnesota
- 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 dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMET + ADA dentifrice FMET Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions. FMET + Foam FMET Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + foam on clinical indicators of gingivitis, plaque, and patient perceptions.
- Primary Outcome Measures
Name Time Method Löe & Silness gingival index (GI) Baseline and 30-days Scale 0-3
Turesky modification of the Quigley-Hein index Baseline and 30-days Scale 0-5
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota School of Dentistry
🇺🇸Minneapolis, Minnesota, United States