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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05055986
Collaborator
(none)
12
1
13.7
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible: A Validity and Reliability Study
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Validity and reliability of CBCT open-source software (ITK-Snap and 3D Slicer) semiautomatic segmentation in Volumetric measurement of mandibular bone. [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of dentistry cairo university Cairo Egypt 11555

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maha Sayed Mohamed Shazly, Teaching Assistant, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05055986
    Other Study ID Numbers:
    • Open-source Software
    First Posted:
    Sep 24, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maha Sayed Mohamed Shazly, Teaching Assistant, Cairo University

    Study Results

    No Results Posted as of Mar 9, 2022