Back to resultsSafety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noval Oral Appliance
Sponsored by
About this trial
This is an interventional device feasibility trial for Obstructive Sleep Apnea focused on measuring oral appliance, sleep apnea, hypoxia
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
safety of device as measured by the number of patients with adverse events
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05018234
First Posted
August 18, 2021
Last Updated
May 24, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05018234
Brief Title
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Official Title
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
oral appliance, sleep apnea, hypoxia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Noval Oral Appliance
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey
Description
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)
Title
Comfort of the novel OA device as measured by the post care patient feedback survey
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Glick, DDS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
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