Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

Conditions
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Oral Hygiene

Intervention / Treatment
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* Device: Enable Oral Hygiene System (EOHS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: First-in-human-use single arm clinical study to evaluate safety.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toothbrush<br>Use of experimental toothbrush for 28 days. | Device: Enable Oral Hygiene System (EOHS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events related to toothbrush use. | Incidence of adverse events related to toothbrush use. | 28 days | 
| Incidence of device failure. | Incidence of device failure. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |