Full-mouth Electronic Toothbrush vs. Conventional Electro... | NCT06561204

Studies
Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush

NCT06561204

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Dec 17, 2025Actual

Enrollment

94Actual

Phase

Not Applicable

Conditions

Toothbrush
Gingivitis
Plaque

Interventions

FMET

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2024Actual

Primary Completion Date

Oct 10, 2025Actual

Completion Date

Oct 10, 2025Actual

First Submitted Date

Aug 16, 2024

First Submission Date that Met QC Criteria

Aug 16, 2024

First Posted Date

Aug 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2025

Last Update Posted Date

Dec 17, 2025Actual

Name	Class
FENO.Co	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMET + ADA dentifrice	Experimental	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.	Device: FMET
Conventional electronic toothbrush + ADA dentifrice	No Intervention	Baseline and 30-day outcome measures will be collected to evaluate the impact of conventional electronic toothbrush + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.
FMET + Foam	Other	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.	Device: FMET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FMET	Device	A full-mouth electronic toothbrush	FMET + ADA dentifrice FMET + Foam

Measure	Description	Time Frame
Löe & Silness gingival index (GI)	Scale 0-3	Baseline and 30-days
Turesky modification of the Quigley-Hein index	Scale 0-5	Baseline and 30-days

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005891	Gingivitis
D058225	Plaque, Amyloid

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases