Movement Disorders and Physical ImpairmentsNCT06632704
Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.
An observational study of Movement Disorders and Physical Impairments, run by Colgate Palmolive at 1 site in United States.
Trial summary
User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Movement Disorders and Physical Impairments
- What is being tested?
- Colgate Toothbrush assist
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 15 Dec 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania school of Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview
Read the detailed description
Video recording of tooth brushing technique Picture of toothbrush bristles after study period
- Being tested
- Colgate Toothbrush assist
- Keywords
- hand movement impairment
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Toothbrush assistDevice
toothbrush handle assignment to all subjects; subjects will have a choice between two brush heads
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Colgate Toothbrush assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
user experience
User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview Video recording of tooth brushing technique Picture of toothbrush bristles
Measured: 1 week, 2 weeks and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement Disorders and Physical ImpairmentsStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Eugene M Ko, DDS, Principal investigator, Deputy Director, Center for Clinical and Translational Research Clinical Associate Professor, Department of Oral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632704
- Sponsor's protocol ID
- CRO-2024-04-MTB-ASSIST HANDLE-
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.
- ClinicalTrials.gov ID
- NCT06632704
- Acronym / sponsor ID
- CRO-2024-04-MTB-ASSIST HANDLE-
- Keywords
- hand movement impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview
Detailed description
Video recording of tooth brushing technique Picture of toothbrush bristles after study period
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults aged 18-70 yrs, if applicable, primary caregiver | – | Device: Colgate Toothbrush assistThe study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colgate Toothbrush assisttoothbrush handle assignment to all subjects; subjects will have a choice between two brush heads | Device | Adults aged 18-70 yrs, if applicable, primary caregiver |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene M Ko, DDS principal investigator
Deputy Director, Center for Clinical and Translational Research Clinical Associate Professor, Department of Oral Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Physical Impairments, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
user experience (time frame: 1 week, 2 weeks and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.