Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
Completed · Not applicable
Conditions studied: Oral Hygiene
In brief
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.
Key facts
- Study ID
- NCT05852886
- Run by
- Center for Disability Services, New York
- People needed
- 12
- Starts
- 2023-03-27
- Expected to finish
- 2023-06-01
- Last updated by the study team
- 2023-06-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Willing to attempt brushing 2 x daily.
- Write and read English.
- 18-65 years of age.
You may not qualify if…
- 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.
Where it is running
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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