Segmentation; BoneNCT05055986
Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible
An observational study of Segmentation; Bone, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Segmentation; Bone
- What is being tested?
- Semiautomatic segmentation of open-source software
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2021to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Good quality CBCT scans.
- Field of view (FOV) including the whole mandibular bone.
- Absence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.
Who cannot join
- Low-quality CBCT scans.
- FOV not including the whole mandibular bone.
- Presence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry cairo university
Cairo, 11555
Maha Sa Mohamed, Master, 01285478360, maha_sayed@dentistry.cu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Segmentation; Bone
- Being tested
- Semiautomatic segmentation of open-source software
- Keywords
- Open source software, Segmentation, Mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiautomatic segmentation of open-source softwareDevice
Also called ITK-Snap software, 3D Slicer software
Semiautomatic segmentation of open-source software is accurate as of the manual segmentation of commercial software.
| Study group | Role | What they receive |
|---|---|---|
| CBCT Dicom files of patients | CBCT Dicom files of patients will be used for measurements of mandibular bone volume by open-source software. Receives: Device: Semiautomatic segmentation of open-source software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start11 Nov 2021
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Segmentation; BoneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sayed Mohamed Shazly, Cairo University
- Investigators
- Maha S Mohamed, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055986
- Sponsor's protocol ID
- Open-source Software
- Status last verified
- Mar 2022
- First submitted
- 11 Sep 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 31267257Matsiushevich 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.
PubMed 30591203Lo 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.
PubMed 32575875Vallaeys 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.
PubMed 25996572
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible: A Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT05055986
- Acronym / sponsor ID
- Open-source Software
- Conditions
- Segmentation; Bone
- Keywords
- Open source software, Segmentation, Mandible
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT Dicom files of patients | – | Device: Semiautomatic segmentation of open-source softwareCBCT Dicom files of patients will be used for measurements of mandibular bone volume by open-source software. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Good quality CBCT scans.
- Field of view (FOV) including the whole mandibular bone.
- Absence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.
Key exclusion criteria (3 listed)
- Low-quality CBCT scans.
- FOV not including the whole mandibular bone.
- Presence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiautomatic segmentation of open-source softwareAlso: ITK-Snap software, 3D Slicer softwareSemiautomatic segmentation of open-source software is accurate as of the manual segmentation of commercial software. | Device | CBCT Dicom files of patients |
Primary outcome
Validity and reliability of CBCT open-source software (ITK-Snap and 3D Slicer) semiautomatic segmentation in Volumetric measurement of mandibular bone.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 31267257Gomes 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.
- Background: PubMed 30591203Matsiushevich 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.
- Background: PubMed 32575875Lo 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.
- Background: PubMed 25996572Vallaeys 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.
- Individual participant dataSharing planned: Yes
Related trials for Segmentation; Bone
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
Not yet recruitingEarly Phase 1
Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons
Not yet recruitingObservational study
Degenerative Changes After Treatment of Thoracolumbar Junction Fractures
Thoracolumbar Spine Fracture, Facet Joint Degeneration
Not yet recruiting
The Lumbar Adjacent Segment Stenosis Trial
Lumbar Adjacent Spinal Stenosis, Chronic Low Back and Leg Pain
Active, not recruiting
Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement
Guided Implant Placement, Delayed Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha S Mohamed, Master principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Segmentation; Bone, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha S Mohamed, Master (01285478360, maha_sayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and reliability of CBCT open-source software (ITK-Snap and 3D Slicer) semiautomatic segmentation in Volumetric measurement of mandibular bone. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055986, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.