Clinical trial NCT06561204: Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush
Official title: Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Toothbrush
Gingivitis
Plaque
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: FENO.Co
First posted: 2024-08-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Löe & Silness gingival index (GI)
timeFrame: Baseline and 30-days
measure: Turesky modification of the Quigley-Hein index
timeFrame: Baseline and 30-days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota School of Dentistry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michelle C Arnett, MS
role: PRINCIPAL_INVESTIGATOR
References: