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

April 30, 2021 updated by: Dr. Maryam Bakhtiyari, Manhattan Beach Orthodontics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Manhattan Beach, California, United States, 90266
        • Manhattan Beach Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D volumetric airway measurement
Time Frame: 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.
through study completion, an average of 1 year
2D Anterior-Posterior airway Measurement
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Beach Orthodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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