Comparing a full-mouth electronic toothbrush to a conventional electronic toothbrush
Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: a Randomized Clinical Trial
This study is testing whether a new full-mouth electronic toothbrush can improve oral health better than a regular electronic toothbrush for people with mild to moderate gingivitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06561204 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a full-mouth electronic toothbrush (FMET) compared to a conventional electronic toothbrush (ETB) in improving oral health. Participants will be randomly assigned to one of three groups: FMET with ADA-approved dentifrice, conventional ETB with ADA dentifrice, or FMET with a foam system. The study will measure clinical indicators of gingivitis and plaque, as well as patient perceptions, over a 30-day period. The trial is conducted at the University of Minnesota School of Dentistry, focusing on patients with mild to moderate gingivitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild to moderate gingivitis and a minimum of five natural teeth in each quadrant.
Not a fit: Patients with severe periodontal disease or those who are not willing to abstain from professional oral hygiene care during the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved oral hygiene practices and better management of gingivitis for patients.
How similar studies have performed: Other studies have shown promising results in improving oral health with electronic toothbrushes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota School of Dentistry — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michelle C Arnett, MS — University of Minnesota
- Study coordinator: Michelle C Arnett, MS
- Email: marnett@umn.edu
- Phone: 612-625-0942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.