Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

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.

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.