RECRUITING

Full-mouth Electronic Toothbrush Vs. Conventional Electronic Toothbrush

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: a Randomized Clinical Trial

Quick Facts

Study Start:2024-12-30

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06561204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Michelle C Arnett, MS

CONTACT

612-625-0942

marnett@umn.edu

Danna R Paulson, MS

CONTACT

Dannardh@umn.edu

Principal Investigator

Michelle C Arnett, MS

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Michelle C Arnett, MS, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-12-30

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Toothbrush
Gingivitis
Plaque