Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

Oral Hygiene Clinical Trial

Official title:

Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852886
• Other study ID #: 22-001
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Center for Disability Services, New York	Tufts University School of Dental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events related to toothbrush use.	Incidence of adverse events related to toothbrush use.	28 days
Primary	Incidence of device failure.	Incidence of device failure.	28 days
Secondary	Perception of cleanliness following use of the experimental toothbrush based on a Likert scale.	Likert scale based questionnaire to assess subjective assessment of cleaning.	28 days