Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device

The University of Texas Health Science Center, Houston5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Noval Oral ApplianceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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

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

Time frame: 1 month after enrollment(appointment 2)

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.

Time frame: 1 week after appointment 2(appointment 3)

Data from ClinicalTrials.gov

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