Cone-Beam Computed TomographyNCT03229018
Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study
A study testing Voxel size in people with Cone-Beam Computed Tomography, run by Cairo University at 1 site in Egypt.
Trial summary
study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cone-Beam Computed Tomography
- What is being tested?
- Voxel size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2018to Sep 2018
- Phase
- Interventional
- 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
Who may be able to join
- Selection of the human dry mandibles will be independent of age, gender and ethnicity.
- They should be intact, free from any bone defects, fractures, pathology.
- Dentate state of the mandibles is not an element in selection criteria; either dentulous or edentulous mandibles are acceptable
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX® 3D Cone Beam Computed Tomography Machine: Preclinical Study
study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes
Read the detailed description
The real linear measurement will be measured in millimeter (mm) on the mandibles using digital caliper in the chosen areas.
CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the dimension in the chosen areas.
- Conditions
- Cone-Beam Computed Tomography
- Being tested
- Voxel size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voxel sizeDiagnostic test
200 μm and 300 μm Voxel Sizes
| Study group | Role | What they receive |
|---|---|---|
| voxel size | Other | 200 μm and 300 μm Voxel Sizes Receives: Diagnostic Test: Voxel size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of linear measurement
Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes
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 posted25 Jul 2017
- Study startJul 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cone-Beam Computed TomographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Selim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229018
- Sponsor's protocol ID
- 1611
- Status last verified
- Jan 2018
- First submitted
- 13 Jul 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX® 3D Cone Beam Computed Tomography Machine: Preclinical Study
- ClinicalTrials.gov ID
- NCT03229018
- Acronym / sponsor ID
- 1611
- Conditions
- Cone-Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 25 Jul 2017 (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.
study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes
Detailed description
The real linear measurement will be measured in millimeter (mm) on the mandibles using digital caliper in the chosen areas.
CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the dimension in the chosen areas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| voxel size | Other | Diagnostic Test: Voxel size200 μm and 300 μm Voxel Sizes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Selection of the human dry mandibles will be independent of age, gender and ethnicity.
- They should be intact, free from any bone defects, fractures, pathology.
- Dentate state of the mandibles is not an element in selection criteria; either dentulous or edentulous mandibles are acceptable
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Voxel size200 μm and 300 μm Voxel Sizes | Diagnostic test | voxel size |
Primary outcome
Diagnostic accuracy of linear measurement
Time frame: 1 year
Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voxel size in people with Cone-Beam Computed Tomography, 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 1 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 25 Jan 2018. 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 Mohamed Selim, BDs (+201147703022, Mohamed.selim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of linear measurement (time frame: 1 year). 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 25 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.