Accuracy of Digital Dental ModelNCT06035432
Accuracy of Digital Models Using Open-access Software Programs
An observational study of Accuracy of Digital Dental Model, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Despite the clear drive toward digital model transformation, there are limitations to some paid software necessary for digital model production. The aim of the study is to compare the accuracy of open-access software against paid software regarding the segmentation process to produce a digital model. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Accuracy of Digital Dental Model
- What is being tested?
- Bluesky software, 3D slicer software and OnDemand software
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 Jul 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who are young adults attending the Periodontology, Oral Medicine, Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University.
Who may be able to join
- Complete records of patients (upper and lower).
- Intact models with complete anatomy.
- Complete permanent dentition
Who cannot join
- Broken or damaged stone models.
- Models of patients with orthodontic appliances or dental prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trueness and Precision of Digital Models Obtained From Different Open-access Software Programs
Background: Despite the clear drive toward digital model transformation, there are limitations to some paid software necessary for digital model production. The aim of the study is to compare the accuracy of open-access software against paid software regarding the segmentation process to produce a digital model. Four groups of software programs will be assessed regarding their accuracy in the segmentation process to produce a digital dental model. The reference models will be scanned by a desktop scanner and will be set as the gold standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data will be converted into STL files by four different software programs.
- Conditions
- Accuracy of Digital Dental Model
- Being tested
- Bluesky software, 3D slicer software, OnDemand software, Mimics software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bluesky softwareOther
Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Bluesky software.
3D slicer softwareOther
Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by 3D slicer software.
OnDemand softwareOther
Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by OnDemand software.
Mimics softwareOther
Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Mimics software.
| Study group | Role | What they receive |
|---|---|---|
| Open access software 1 | Not described Receives: Other: Bluesky software | |
| Open access software 2 | Not described Receives: Other: 3D slicer software | |
| Non open access paid software 1 | Not described Receives: Other: OnDemand software | |
| Non open access paid software 2 | Not described Receives: Other: Mimics software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation in digital models measurments
3D deviation analysis will be done between the digital models of each participant and the reference model by reverse engineering 3-Matics software (Materialise NV, Belgium, Version 11.0). Each two STL models will be imported into the software. The mean deviation difference (measured in mm) will be calculated by 'Analyse' tool present in the software
Measured: through study completion, up to 3 months
Secondary outcomes (2)
Linear measurements
Each digital model will be measured in the three dimensions:
- Anteroposterior (the canine cusp tip to the mesiobuccal cusp tip of the first molar on the right side).
- Transverse (inter-canine and inter-molar).
- Vertical (the canine height, which is measured from the cusp tip to the gingival margin of the right canine by a line parallel to the long axis of the tooth).
Measured: through study completion, up to 3 months
Teeth crown width
For all teeth (twelve measurements for each arch), first molar to first molar, in both arches, the tooth measurements will include the mesiodistal widths from point contact to point contact.
Measured: through study completion, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 May 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of Digital Dental ModelStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Noha ElKersh, PhD, Principal investigator, Alexandria University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035432
- Sponsor's protocol ID
- Digital Models 2023
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trueness and Precision of Digital Models Obtained From Different Open-access Software Programs
- ClinicalTrials.gov ID
- NCT06035432
- Acronym / sponsor ID
- Digital Models 2023
- Conditions
- Accuracy of Digital Dental Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 13 Sep 2023 (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.
Background: Despite the clear drive toward digital model transformation, there are limitations to some paid software necessary for digital model production. The aim of the study is to compare the accuracy of open-access software against paid software regarding the segmentation process to produce a digital model. Four groups of software programs will be assessed regarding their accuracy in the segmentation process to produce a digital dental model. The reference models will be scanned by a desktop scanner and will be set as the gold standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data will be converted into STL files by four different software programs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open access software 1 | – | Other: Bluesky software |
| Open access software 2 | – | Other: 3D slicer software |
| Non open access paid software 1 | – | Other: OnDemand software |
| Non open access paid software 2 | – | Other: Mimics software |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who are young adults attending the Periodontology, Oral Medicine, Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University.
Key inclusion criteria (3 listed)
- Complete records of patients (upper and lower).
- Intact models with complete anatomy.
- Complete permanent dentition
Key exclusion criteria (2 listed)
- Broken or damaged stone models.
- Models of patients with orthodontic appliances or dental prosthesis
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 |
|---|---|---|
| Bluesky softwareDental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Bluesky software. | Other | Open access software 1 |
| 3D slicer softwareDental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by 3D slicer software. | Other | Open access software 2 |
| OnDemand softwareDental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by OnDemand software. | Other | Non open access paid software 1 |
| Mimics softwareDental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Mimics software. | Other | Non open access paid software 2 |
Primary outcome
Deviation in digital models measurments
Time frame: through study completion, up to 3 months
3D deviation analysis will be done between the digital models of each participant and the reference model by reverse engineering 3-Matics software (Materialise NV, Belgium, Version 11.0). Each two STL models will be imported into the software. The mean deviation difference (measured in mm) will be calculated by 'Analyse' tool present in the software
2 secondary outcomes
Linear measurements
Time frame: through study completion, up to 3 months
Teeth crown width
Time frame: through study completion, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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.
Noha ElKersh, PhD principal investigator
Alexandria University, Faculty of Dentistry
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 Accuracy of Digital Dental Model, run by Hams Hamed Abdelrahman 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 2 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: finished, as of the sponsor's last update on 13 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviation in digital models measurments (time frame: through study completion, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.