Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible

Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible: A Validity and Reliability Study

Concomitant to the evolution of CBCT devices, several post-processing software packages were developed for producing 3D-printed models of anatomical structures. In the last few years, several open-source software used as an alternative to commercial software for 3D reconstruction of anatomical structures such as the mandible. However, no sufficient evidence validating the accuracy of this open-source software.

Study Overview

• Status: Recruiting
• Conditions: Segmentation; Bone
• Intervention / Treatment: Device: Semiautomatic segmentation of open-source software

Detailed Description

3D rendering of craniomaxillofacial structures is based on the segmentation process. Semi-automatic segmentation has been pointed out as the technique of choice since it combines the high efficiency and repeatability of the automatic methods with the experience of an operator. Although the creation of 3D models is very important, it is still not a common procedure, since commercial software often requires higher electronic computer power and is licensed by its manufacturer, increasing the financial costs. In the last few years, several open-source software can be obtained for free such as ITK-Snap and 3D Slicer, which could provide more economical options for clinicians or researchers in patient management. However, no sufficient evidence validating the accuracy of this open-source software in detecting the volumetric and morphological characteristics of craniomaxillofacial structures.

• Study Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

• Study Contact: Name: Maha S Mohamed, Master; Phone Number: 01285478360; Email: maha_sayed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11555
    • Recruiting
    • Faculty of dentistry cairo university
    • Contact: Maha Sa Mohamed, Master; Phone Number: 01285478360; Email: maha_sayed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who come to the Oral and Maxillofacial Department, Faculty of Dentistry, Cairo University for CBCT imaging for orthodontic treatment. Patients will be with intact mandible and free of any injury or disease that can affect the volume of the mandible.

Description

Inclusion Criteria:

• Good quality CBCT scans.
• Field of view (FOV) including the whole mandibular bone.
• Absence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.

Exclusion Criteria:

• Low-quality CBCT scans.
• FOV not including the whole mandibular bone.
• Presence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CBCT Dicom files of patients; CBCT Dicom files of patients will be used for measurements of mandibular bone volume by open-source software.	Device: Semiautomatic segmentation of open-source software; Semiautomatic segmentation of open-source software is accurate as of the manual segmentation of commercial software.; Other Names: ITK-Snap software; 3D Slicer software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity and reliability of CBCT open-source software (ITK-Snap and 3D Slicer) semiautomatic segmentation in Volumetric measurement of mandibular bone.	The volume calculation function tool of the dedicated CBCT open-source software (ITK-Snap and 3D Slicer) will be used to measure the mandibular bone volume.	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Maha S Mohamed, Master, Cairo University

Publications and helpful links

General Publications

• Gomes AF, Brasil DM, Silva AIV, Freitas DQ, Haiter-Neto F, Groppo FC. Accuracy of ITK-SNAP software for 3D analysis of a non-regular topography structure. Oral Radiol. 2020 Apr;36(2):183-189. doi: 10.1007/s11282-019-00397-y. Epub 2019 Jul 2.
• Matsiushevich K, Belvedere C, Leardini A, Durante S. Quantitative comparison of freeware software for bone mesh from DICOM files. J Biomech. 2019 Feb 14;84:247-251. doi: 10.1016/j.jbiomech.2018.12.031. Epub 2018 Dec 21.
• Lo Giudice A, Ronsivalle V, Grippaudo C, Lucchese A, Muraglie S, Lagravere MO, Isola G. One Step before 3D Printing-Evaluation of Imaging Software Accuracy for 3-Dimensional Analysis of the Mandible: A Comparative Study Using a Surface-to-Surface Matching Technique. Materials (Basel). 2020 Jun 21;13(12):2798. doi: 10.3390/ma13122798.
• Vallaeys K, Kacem A, Legoux H, Le Tenier M, Hamitouche C, Arbab-Chirani R. 3D dento-maxillary osteolytic lesion and active contour segmentation pilot study in CBCT: semi-automatic vs manual methods. Dentomaxillofac Radiol. 2015;44(8):20150079. doi: 10.1259/dmfr.20150079. Epub 2015 May 21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2021
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (ACTUAL): September 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Mandible; Segmentation; Open source software
• Other Study ID Numbers: Open-source Software

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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