Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05852886 |
Other study ID # |
22-001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 27, 2023 |
Est. completion date |
June 1, 2023 |
Study information
Verified date |
June 2023 |
Source |
Center for Disability Services, New York |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.