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

Completed

• Conditions: Sleep Apnea; OSA
• Interventions: Procedure: Mandible slacked and captured with Correct Plus™ Impression Material Superfast

• Registration Number: NCT04874727
• Lead Sponsor: Manhattan Beach Orthodontics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2021-01-18
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-30
• Last Update Submitted: 2021-04-30
• Study First Posted: 2021-05-06
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Participant must be a patient of Dr. Maryam Bakhtiyari's orthodontic practice
• Participant must have a diagnosis of obstructive sleep apnea
• Participant must have an invitation to join research study from Dr. Bakhtiyari

Exclusion Criteria

• Participant cannot have a history of serious dental trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Population	Mandible slacked and captured with Correct Plus™ Impression Material Superfast	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Manhattan Beach Orthodontics; 🇺🇸 Manhattan Beach, California, United States