- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035432
Accuracy of Digital Models Using Open-access Software Programs
September 6, 2023 updated by: Hams Hamed Abdelrahman
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt
- Alexandria Faculty of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who are young adults attending the Periodontology, Oral Medicine, Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University.
Description
Inclusion Criteria:
- Complete records of patients (upper and lower).
- Intact models with complete anatomy.
- Complete permanent dentition
Exclusion Criteria:
- Broken or damaged stone models.
- Models of patients with orthodontic appliances or dental prosthesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Open access software 1
|
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.
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Open access software 2
|
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.
|
Non open access paid software 1
|
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.
|
Non open access paid software 2
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linear measurements
Time Frame: through study completion, up to 3 months
|
Each digital model will be measured in the three dimensions:
|
through study completion, up to 3 months
|
Teeth crown width
Time Frame: through study completion, up to 3 months
|
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.
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through study completion, up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Noha ElKersh, PhD, Alexandria University, Faculty of dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
July 30, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
April 26, 2023
First Submitted That Met QC Criteria
September 6, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Digital Models 2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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