Oral HygieneNCT05852886
Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
A study testing Enable Oral Hygiene System (EOHS) in people with Oral Hygiene, run by Center for Disability Services, New York at 1 site in United States.
Trial summary
The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end. EOHS is intended for a caregiver to use to remove adherent plaque and food debris from the teeth of a consumer to reduce tooth decay. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Enable Oral Hygiene System (EOHS)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 1 Jun 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to attempt brushing 2 x daily.
- Write and read English.
- 18-65 years of age.
Who cannot join
- Individuals who identify as a dentist, dental student, or a dental professional.
- Any physical limitations that might compromise normal tooth brushing technique.
- Teeth with orthodontic appliances.
- Evidence of periodontal abscess or major hard or soft tissue lesions or trauma.
- Use of anti-inflammatory medications for three or more consecutive days in the previous 28 days.
- Not willing to comply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 021111
About this study
The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end. EOHS is intended for a caregiver to use to remove adherent plaque and food debris from the teeth of a consumer to reduce tooth decay. Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety is a first-in-human-use single arm clinical study to evaluate the safety of EOHS. This study has been designed to assess the safety of the device during self-brushing. The primary objective of the study is to evaluate the safety of the EOHS with able-bodied individuals during self-brushing. The primary endpoint for safety is 28 days. The primary endpoint of the study will be met if there are no device failures and no Adverse Device Effects (ADEs). Subjective assessment of cleaning using the EHOS during self-brushing will also be evaluated. A total of up to 12 subjects will be enrolled in the study.
Read the detailed description
Twelve subjects will be recruited to evaluate the Enable Oral Hygiene System (EOHS) for safety. Subjects will be asked to complete demographic information and a medical history. An oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed following standard of care procedures. Inclusion/exclusion criteria will be evaluated and eligibility for the study will be determined. Subjects who qualify for participation in the study will receive an EOHS toothbrush with the instructions for use accompanied within the product package. Subjects will then watch an instructional video demonstrating the use of the novel toothbrush. For 28 days, subjects will use the EOHS during normal (self) brushing twice daily. Subjects will be asked to record daily impressions of comfort, ease of use, and perceived cleanliness. At the conclusion of the study, subjects will record overall subjective impressions of comfort, ease of use, and perceived cleanliness. Any device related failures, adverse events, or safety concerns will be recorded. After 28 days, an oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed following standard of care procedures. Subjects will be asked to return daily and overall impression documents as well as the EOHS.
- Conditions
- Oral Hygiene
- Being tested
- Enable Oral Hygiene System (EOHS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enable Oral Hygiene System (EOHS)Device
The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end.
| Study group | Role | What they receive |
|---|---|---|
| Toothbrush | Experimental | Use of experimental toothbrush for 28 days. Receives: Device: Enable Oral Hygiene System (EOHS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events related to toothbrush use.
Incidence of adverse events related to toothbrush use.
Measured: 28 days
Incidence of device failure.
Incidence of device failure.
Measured: 28 days
Secondary outcomes (1)
Perception of cleanliness following use of the experimental toothbrush based on a Likert scale.
Likert scale based questionnaire to assess subjective assessment of cleaning.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start27 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First-in-human-use single arm clinical study to evaluate safety.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Disability Services, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University School of Dental Medicine
- Responsible party
- Sponsor
- Investigators
- Adam Lowenstein, MS, DMD, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852886
- Sponsor's protocol ID
- 22-001
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
- ClinicalTrials.gov ID
- NCT05852886
- Acronym / sponsor ID
- 22-001
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Center for Disability Services, New YorkUniversity, hospital or other
- Collaborators
- Tufts University School of Dental Medicine
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 May 2023 (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.
The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end. EOHS is intended for a caregiver to use to remove adherent plaque and food debris from the teeth of a consumer to reduce tooth decay. Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety is a first-in-human-use single arm clinical study to evaluate the safety of EOHS. This study has been designed to assess the safety of the device during self-brushing. The primary objective of the study is to evaluate the safety of the EOHS with able-bodied individuals during self-brushing. The primary endpoint for safety is 28 days. The primary endpoint of the study will be met if there are no device failures and no Adverse Device Effects (ADEs). Subjective assessment of cleaning using the EHOS during self-brushing will also be evaluated. A total of up to 12 subjects will be enrolled in the study.
Detailed description
Twelve subjects will be recruited to evaluate the Enable Oral Hygiene System (EOHS) for safety. Subjects will be asked to complete demographic information and a medical history. An oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed following standard of care procedures. Inclusion/exclusion criteria will be evaluated and eligibility for the study will be determined. Subjects who qualify for participation in the study will receive an EOHS toothbrush with the instructions for use accompanied within the product package. Subjects will then watch an instructional video demonstrating the use of the novel toothbrush. For 28 days, subjects will use the EOHS during normal (self) brushing twice daily. Subjects will be asked to record daily impressions of comfort, ease of use, and perceived cleanliness. At the conclusion of the study, subjects will record overall subjective impressions of comfort, ease of use, and perceived cleanliness. Any device related failures, adverse events, or safety concerns will be recorded. After 28 days, an oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed following standard of care procedures. Subjects will be asked to return daily and overall impression documents as well as the EOHS.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First-in-human-use single arm clinical study to evaluate safety.
| Arm | Type | Receives |
|---|---|---|
| Toothbrush | Experimental | Device: Enable Oral Hygiene System (EOHS)Use of experimental toothbrush for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to attempt brushing 2 x daily.
- Write and read English.
- 18-65 years of age.
Key exclusion criteria (6 listed)
- Individuals who identify as a dentist, dental student, or a dental professional.
- Any physical limitations that might compromise normal tooth brushing technique.
- Teeth with orthodontic appliances.
- Evidence of periodontal abscess or major hard or soft tissue lesions or trauma.
- Use of anti-inflammatory medications for three or more consecutive days in the previous 28 days.
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 |
|---|---|---|
| Enable Oral Hygiene System (EOHS)The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end. | Device | Toothbrush |
Primary outcome
Incidence of adverse events related to toothbrush use.
Time frame: 28 days
Incidence of adverse events related to toothbrush use.
Incidence of device failure.
Time frame: 28 days
Incidence of device failure.
1 secondary outcome
Perception of cleanliness following use of the experimental toothbrush based on a Likert scale.
Time frame: 28 days
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 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Adam Lowenstein, MS, DMD principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enable Oral Hygiene System (EOHS) in people with Oral Hygiene, run by Center for Disability Services, New York 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 3 inclusion and 6 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 15 Jun 2023. 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?
Incidence of adverse events related to toothbrush use. (time frame: 28 days). The study lists 2 primary outcomes in all. 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 15 Jun 2023.