NCT05852886

Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Center for Disability Services, New York · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-03-27
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-05-10
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study