Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.

Official Title
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Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Noval Oral Appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No history of obstructive sleep apnea No active jaw joint pain No active moderate to severe periodontal disease Presence of 12 teeth per arch Exclusion Criteria: presence of severe bruxism

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Noval Oral Appliance<br>* A scan of the mouth will be performed to make the oral device. The device will be 3D printed with Asiga UV Max printer using FDA 510(k) cleared VeriSplint OS Resin.Subjects will be will be asked to wear the oral device at night for 3 nights and fill out a survey reviewing their experience wearing the device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of device as measured by the number of patients with adverse events |  | During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey | Comfort will be assessed through a numerical rating scale and short answer survey that will assess comfort and user feedback while wearing the novel OA device. There are 4 questions in the survey, the first one has 5 answer choices about how the appliance fits to the teeth and ranges from very tight fit to very loose fit .The rest of the questions are rated form 1-10,a higher number indicating more comfort | 1 month after enrollment(appointment 2) | 
| Comfort of the novel OA device as measured by the post care patient feedback survey | Comfort will be assessed through a numerical rating scale and short answer survey that will assess comfort and user feedback while wearing the novel OA device.There are 12 questions in the survey, the first one has 5 answer choices about how the appliance fits to the teeth and ranges from very tight fit to very loose fit .The next 8 questions are rated form 1-10,a higher number indicating more comfort, the 9th question indicates any adverse events and the last 3 questions are short answer questions describing the patient's experience with the device. | 1 week after appointment 2(appointment 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral appliance, sleep apnea, hypoxia