Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Noval Oral Appliance

• Registration Number: NCT05018234
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-04
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Noval Oral Appliance	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey	1 month after enrollment(appointment 2)	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
Comfort of the novel OA device as measured by the post care patient feedback survey	1 week after appointment 2(appointment 3)	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States