Trials / Completed
CompletedNCT05018234
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Noval Oral Appliance | 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. |
Timeline
- Start date
- 2021-08-04
- Primary completion
- 2022-03-01
- Completion
- 2022-04-01
- First posted
- 2021-08-24
- Last updated
- 2022-05-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05018234. Inclusion in this directory is not an endorsement.