Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.

April 10, 2025 updated by: Colgate Palmolive
User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Video recording of tooth brushing technique Picture of toothbrush bristles after study period

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Dental Medicine

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.

Description

Inclusion Criteria:

  • Individuals with specific movement disorders and physical impairments, such as, but not limited to, Parkinson disease, Huntington disease, multiple sclerosis, arthritis, cerebral palsy, stroke, and/or tremors that affect their ability to perform daily tasks, such as brushing their teeth.

Exclusion Criteria:

  • Individuals with severe oral health issues such as oral cancer, ulcers, or severe periodontal disease.
  • Individuals who are unable to open their mouth enough that it would prevent using a brushing device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults aged 18-70 yrs, if applicable, primary caregiver
The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.
Device: Colgate Toothbrush assist
toothbrush handle assignment to all subjects; subjects will have a choice between two brush heads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
user experience
Time Frame: 1 week, 2 weeks and 3 weeks
User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview Video recording of tooth brushing technique Picture of toothbrush bristles
1 week, 2 weeks and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Eugene M Ko, DDS, Deputy Director, Center for Clinical and Translational Research Clinical Associate Professor, Department of Oral Medicine

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 Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2024-04-MTB-ASSIST HANDLE-

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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