Gingivitis, Plaque, Toothbrush
Conditions
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.
Interventions
DEVICEFMET
A full-mouth electronic toothbrush
Sponsors
FENO.Co
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed