Segmentation TechniquesCBCTNCT05435417
Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT
A study testing CBCT radiation in people with Segmentation Techniques, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Segmentation Techniques
- What is being tested?
- CBCT radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 30 Dec 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intact dry human skulls and mandibles.
Who cannot join
- Presence of fracture, pathological lesions, or skeletal deformities in the condylar area.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Cairo University
Cairo
Enas El Saket, PHD degree, +201001243575, enas_saket@dentistry.cu.edu.eg
About this study
Official title: Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT(A Diagnostic Accuracy Study)
Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT
Read the detailed description
It will be used to segment the mandibular condyle and asses its volumetric and linear measurements. Therefore, the accuracy of the segmentation techniques of the mandibular condyle will be determined
- Conditions
- Segmentation Techniques
- Being tested
- CBCT radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT radiationRadiation
CBCT scanning
| Study group | Role | What they receive |
|---|---|---|
| Manual segmentation technique of CBCT images of the condyles. | Experimental | Using the manual edition built in tool, first a brush of small size will be used to demarcate the outline of the condyle in the sagittal cuts. Then shading the demarcated condylar area with a brush of larger size in each slice. The outline of the condyle will be refined on all cuts. The software built in tool 'create surface' will be used to create the segmented 3D volume Receives: Radiation: CBCT radiation |
| Semiautomatic segmentation technique of CBCT images of the condyles. | Experimental | Using the water shed built in tool, first a brush of small size will be used to demarcate the outline of the condyle by the 'background' option in all planes. Then using the 'foreground' option, a brush of larger size will be used to shade the condylar area. The software built in tool 'expand water shed' will be used to include the whole condyle. At last, 'create surface' option will be used to create the segmented 3D volume. Receives: Radiation: CBCT radiation |
| Actual physical measurements of the condyles on the dry mandibles | No intervention | For linear measurements, actual physical measurements will be done on the dry mandibular condyles, using digital caliper, as mentioned before. For volumetric measurements, water displacement technique will be used. The mandibular condyle will be immersed in a graduated beaker containing water till the level of the glued gutta percha. The volume of the displaced water will be measured and will represent the actual volume of the condyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear assessment of the condyles
Linear measurements will be calculated in millimeters by Built-in measuring tool (ruler) in the software + digital caliper on the dry mandibles
Measured: one month
Secondary outcomes (1)
Volumetric assessment of the condyles
For volumetric measurements, the volume of the segmented condyle, either by manual or semiautomatic segmentation technique, will be automatically calculated by the software. Volumetric measurements will be calculated in cubic millimeters.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022
- Primary completion20 Nov 2022 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Segmentation TechniquesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas El Saket, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435417
- Sponsor's protocol ID
- RAD 7:1-1
- Acronym
- CBCT
- Status last verified
- Oct 2022
- First submitted
- 23 Jun 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Saket E, Anter E, Abd El Samad AM. Effect of segmentation techniques (manual versus semiautomatic) on the accuracy of the linear measurements driven from the reconstructed mandibular condyle using CBCT. BMC Oral Health. 2026 Mar 17;26(1):721. doi: 10.1186/s12903-026-07947-x.
PubMed 41845343
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT(A Diagnostic Accuracy Study)
- ClinicalTrials.gov ID
- NCT05435417
- Acronym / sponsor ID
- CBCT / RAD 7:1-1
- Conditions
- Segmentation Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jun 2022 (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.
Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT
Detailed description
It will be used to segment the mandibular condyle and asses its volumetric and linear measurements. Therefore, the accuracy of the segmentation techniques of the mandibular condyle will be determined
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual segmentation technique of CBCT images of the condyles. | Experimental | Radiation: CBCT radiationUsing the manual edition built in tool, first a brush of small size will be used to demarcate the outline of the condyle in the sagittal cuts. Then shading the demarcated condylar area with a brush of larger size in each slice. The outline of the condyle will be refined on all cuts. The software built in tool 'create surface' will be used to create the segmented 3D volume |
| Semiautomatic segmentation technique of CBCT images of the condyles. | Experimental | Radiation: CBCT radiationUsing the water shed built in tool, first a brush of small size will be used to demarcate the outline of the condyle by the 'background' option in all planes. Then using the 'foreground' option, a brush of larger size will be used to shade the condylar area. The software built in tool 'expand water shed' will be used to include the whole condyle. At last, 'create surface' option will be used to create the segmented 3D volume. |
| Actual physical measurements of the condyles on the dry mandibles | No intervention | –For linear measurements, actual physical measurements will be done on the dry mandibular condyles, using digital caliper, as mentioned before. For volumetric measurements, water displacement technique will be used. The mandibular condyle will be immersed in a graduated beaker containing water till the level of the glued gutta percha. The volume of the displaced water will be measured and will represent the actual volume of the condyle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Intact dry human skulls and mandibles.
Key exclusion criteria (1 listed)
- Presence of fracture, pathological lesions, or skeletal deformities in the condylar area.
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 |
|---|---|---|
| CBCT radiationCBCT scanning | Radiation | Manual segmentation technique of CBCT images of the condyles., Semiautomatic segmentation technique of CBCT images of the condyles. |
Primary outcome
Linear assessment of the condyles
Time frame: one month
Linear measurements will be calculated in millimeters by Built-in measuring tool (ruler) in the software + digital caliper on the dry mandibles
1 secondary outcome
Volumetric assessment of the condyles
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 41845343El Saket E, Anter E, Abd El Samad AM. Effect of segmentation techniques (manual versus semiautomatic) on the accuracy of the linear measurements driven from the reconstructed mandibular condyle using CBCT. BMC Oral Health. 2026 Mar 17;26(1):721. doi: 10.1186/s12903-026-07947-x.
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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 CBCT radiation in people with Segmentation Techniques, 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 1 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 6 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear assessment of the condyles (time frame: one month). 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 NCT05435417, which also lists 1 linked publication.
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 6 Oct 2022.