Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

Obstructive Sleep Apnea Clinical Trial

Official title:

Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018234
• Other study ID #: HSC-DB-21-0472
• Status: Completed
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)