Clinical trial NCT05852886: Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
Official title: Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: Center for Disability Services, New York
Sponsor class: OTHER
Collaborators: name: Tufts University School of Dental Medicine
First posted: 2023-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First-in-human-use single arm clinical study to evaluate safety.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Willing to attempt brushing 2 x daily.
* Write and read English.
* 18-65 years of age.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of adverse events related to toothbrush use.
timeFrame: 28 days
measure: Incidence of device failure.
timeFrame: 28 days
Secondary outcomes:
measure: Perception of cleanliness following use of the experimental toothbrush based on a Likert scale.
timeFrame: 28 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Adam Lowenstein, MS, DMD
role: PRINCIPAL_INVESTIGATOR
References: