Clinical trial NCT05055986: Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible
Official title: Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible: A Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Segmentation; Bone
Keywords: Open source software
Segmentation
Mandible
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Validity and reliability of CBCT open-source software (ITK-Snap and 3D Slicer) semiautomatic segmentation in Volumetric measurement of mandibular bone.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo university
Study officials:
affiliation: Cairo University
name: Maha S Mohamed, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.