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

Sleep Apnea Clinical Trial

— OSA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874727
• Other study ID #: 0002
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Manhattan Beach Orthodontics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• OSA
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Manhattan Beach Orthodontics	Manhattan Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Manhattan Beach Orthodontics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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