Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

The University of Texas System (UT)

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Noval Oral Appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT05018234

HSC-DB-21-0472

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: Noval Oral Appliance