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

NCT04874727 | Completed

• 1 other identifier: 0002
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA; Sleep Apnea

Keywords

tomography; CBCT; Cone-beam computerized tomography; obstructive sleep apnea; airway volume; anterior-posterior measurement

Outcome Measures

Primary Outcomes (2)

• 3D volumetric airway measurement

  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.

  through study completion, an average of 1 year

• 2D Anterior-Posterior airway Measurement

  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.

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Mandible slacked and captured with Correct Plus™ Impression Material Superfast PROCEDURE

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.

Study Population

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population was selected from the patient pool of Dr. Maryam Bakhtiyari. They are individuals with diagnoses of OSA and consented to taking two x-rays and enrolling into this study.

You may qualify if:

• 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

You may not qualify if:

• Participant cannot have a history of serious dental trauma

Sponsors & Collaborators

• Manhattan Beach Orthodontics: lead

Study Sites (1)

Manhattan Beach Orthodontics

Manhattan Beach, California, 90266, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, Owner

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: May 6, 2021
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)