NCT05018234CompletedNot Applicable
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
The University of Texas Health Science Center, Houston1 site in 1 country5 target enrollmentStarted: August 4, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- safety of device as measured by the number of patients with adverse events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Treatment
Experimental
Intervention: Noval Oral Appliance (Device)
Outcomes
Primary Outcomes
safety of device as measured by the number of patients with adverse events
Time Frame: 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 Outcomes
- Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey(1 month after enrollment(appointment 2))
- Comfort of the novel OA device as measured by the post care patient feedback survey(1 week after appointment 2(appointment 3))
Investigators
Aaron Glick
Assistant Professor
The University of Texas Health Science Center, Houston
Study Sites (1)
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