Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

The University of Texas System (UT) logo

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

5 participants in 1 patient group

Treatment
Experimental group
Treatment:
Device: Noval Oral Appliance

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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