Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
NCT ID: NCT05018234
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2021-08-04
2022-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* No active jaw joint pain
* No active moderate to severe periodontal disease
* Presence of 12 teeth per arch
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Aaron Glick
Assistant Professor
Principal Investigators
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Aaron Glick, DDS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-DB-21-0472
Identifier Type: -
Identifier Source: org_study_id
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