CBCT Segmentation in Volumetric Measurements of MS Using Different Soft Wares: A Validity and Reliability Study

Cone Beam Computed Tomographic Segmentation in Volumetric Measurements of Maxillary Sinus Using Different Soft Wares: A Validity and Reliability Study

Cone Beam Computed Tomography (CBCT) has been used to assess the volume of the maxillary sinus using the manual and semi-automatic segmentation. The majority of researches stressed on the reduced accuracy of the automatic segmentation when compared to the real volume. Regarding the semi-automatic segmentation, there are researches assessed the volumetric measurement of the maxillary sinus and they reported that there is no significant difference between semi- automatic and the manual segmentation in CT.

Study Overview

• Status: Unknown
• Conditions: Sinus Volume; CBCT Segmentation
• Intervention / Treatment: Device: semiautomatic software

Detailed Description

Automatic segmentation is believed to be less time consuming and more accurate in assessment of structures with regular border but fairly assessed the structures with irregular border like paranasal sinuses. The semi-automatic software is efficient and accurate as manual tracing with significant reduction in inter-observer variability and time . On the other hand, all neighboring contacting voxels located within a defined range (threshold) of similar HU values of different adjacent tissues may be measured so over calculation or under calculation could be suspected

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Inclusion Criteria of participants of the In vitro part of the study:

• Skulls with intact walls of maxillary sinus.
• Skulls with dentulous or edentulous jaws.

Exclusion criteria of participants:

• Skulls with missing parts of the maxilla that could be caused from traumatic injuries, diseases and space occupying lesions of maxilla.
• Skulls with severe mutilation caused by environmental decay.

Inclusion Criteria of participants of the In vivo part of the study:

• Patients without any pathosis affects maxillary sinus.
• Patients with dentulous or edentulous jaws.

Exclusion criteria of participants:

• Patients with traumatic injuries, diseases and space occupying lesions of maxilla.
• Patients with sinus lifting or surgeries.
• Patients with mucosal thickening more than 3mm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patient; CBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software	Device: semiautomatic software; semiautomatic segmentation is as accurate as the direct volume of maxillary sinus and as well as the manual segmentation.; Other Names: Mimics medical 19.; Romexis; On Demand 3D
Other: skulls; CBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software	Device: semiautomatic software; semiautomatic segmentation is as accurate as the direct volume of maxillary sinus and as well as the manual segmentation.; Other Names: Mimics medical 19.; Romexis; On Demand 3D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity and reliability of CBCT semiautomatic segmentation in Volumetric measurements of maxillary sinus.	validity and reliability	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Reham Ashraf, master, Reham Ashraf Hussien

Publications and helpful links

General Publications

• Berberi A, Bouserhal L, Nader N, Assaf RB, Nassif NB, Bouserhal J, Salameh Z. Evaluation of Three-Dimensional Volumetric Changes After Sinus Floor Augmentation with Mineralized Cortical Bone Allograft. J Maxillofac Oral Surg. 2015 Sep;14(3):624-9. doi: 10.1007/s12663-014-0736-3. Epub 2014 Dec 24.
• Alsufyani NA, Flores-Mir C, Major PW. Three-dimensional segmentation of the upper airway using cone beam CT: a systematic review. Dentomaxillofac Radiol. 2012 May;41(4):276-84. doi: 10.1259/dmfr/79433138.
• El H, Palomo JM. Measuring the airway in 3 dimensions: a reliability and accuracy study. Am J Orthod Dentofacial Orthop. 2010 Apr;137(4 Suppl):S50.e1-9; discussion S50-2. doi: 10.1016/j.ajodo.2010.01.014.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: CBCT; maxillary sinus; segmentation
• Other Study ID Numbers: Dentistry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No