OSA: Comparison of Standing Versus Supine 3D Cone Beam Computed Tomography in Patient With Obstructive Sleep Apnea

Sponsor

Manhattan Beach Orthodontics (Other)

Overall Status

Completed

CT.gov ID

NCT04874727

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The anatomical changes of the upper airway in a standing vs pseudo-supine position using Carestream Orthodontic Imaging (Volumetric) and Carestream Orthodontic Imaging module (AP measurements) of the patient's airway respectively, have been taken and the obtained results compared. In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.

Condition or Disease	Intervention/Treatment	Phase
OSA Sleep Apnea	Procedure: Mandible slacked and captured with Correct Plus™ Impression Material Superfast

Study Design

Study Type:

Observational

Actual Enrollment :

6 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Reduction of Volumetric and AP Measurements of the Airway in Pseudo-sleep Supine Position vs Standard 3D Cone Beam Computed Tomography on Patients With Sleep Apnea

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Study Population The five or six individual patients enrolled are the members of the sole group, the study population. These individuals all have been diagnosed with obstructive sleep apnea and have take a Cone-beam CT scan with and without the new bite technique.	Procedure: Mandible slacked and captured with Correct Plus™ Impression Material Superfast In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.

Arm

Intervention/Treatment

Study Population

The five or six individual patients enrolled are the members of the sole group, the study population. These individuals all have been diagnosed with obstructive sleep apnea and have take a Cone-beam CT scan with and without the new bite technique.

Procedure: Mandible slacked and captured with Correct Plus™ Impression Material Superfast

In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.

Outcome Measures

Primary Outcome Measures

3D volumetric airway measurement [through study completion, an average of 1 year]
Investigators will measure and compare the 3D volumetric airway of the x-ray both with and without the pseudo-supine technique. This will be done on the computer using Carestream Orthodontic Imaging.
2D Anterior-Posterior airway Measurement [through study completion, an average of 1 year]
Investigators will measure and compare the 2D anterior-posterior airway of the x-ray both with and without the pseudo-supine technique. This will be done on the computer using the Carestream Orthodontic Imaging module.