CBCT - Condyle - Semi-automated Segmentation - Ultra-low DoseNCT05441423
Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)
A study testing CBCT in people with CBCT - Condyle - Semi-automated Segmentation - Ultra-low Dose, run by Cairo University.
Trial summary
The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CBCT - Condyle - Semi-automated Segmentation - Ultra-low Dose
- What is being tested?
- CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 May 2024
- 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
- mandibles with sound condyles
- skulls with sound glenoid fossa.
Who cannot join
- skulls with fractured glenoid fossa,
- glenoid fossa with developmental deformities,
- mandibles with fractured condylar neck or head,
- presence of pathological lesions,
- fracture,
- Shipping,
- developmental deformities in the condyle.
About this study
The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine \& Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.
Read the detailed description
The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine \& Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.
R (Reference standard): Physical real linear measurements of the condyles will be considered as reference standard, where distances will be measured by digital caliper on the dry human in millimeters as supported by García-Sanz et al. (2017) \& (Kim et al., 2020).
Volumetric measurements form the dry human condyles will be considered as reference standard where water displacement method will be used (according to Archimedes' principle), by immersion of the condyle under investigation in a water filled graduated transparent glass container, after being hangered from a L-shaped metal hanger by using a rope, till the complete immersion of the condylar volume (which was demarcated by using the gutta percha points) under the water level, this will provide more standardization. Then, the displaced amount of water, will be observed and then aspirated by a graduated pipette to calculate its volume in cubic millimeters. This technique was supported by García-Sanz et al. (2017).
- Being tested
- CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
CBCT Scans. conventional \& ultra low dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Measurements
Linear assessment will be done by applying the same landmarks on the both segmented condyles (yielded rom Conventional and Ultralow dose CBCT imaging), Distances will be measured on the segmented condyles from the segmentation software in millimeters. The linear distances according to García-Sanz et al. (2017) will be as follows:
- Line 1: Condylar width measured as the distance between lateral and medial landmarks.
- Line 2: Condylar length measured as distance between anterior and posterior landmarks.
- Line 3: Condylar height measured as distance of the perpendicular line traced from superior point to line 1.
Measured: 1 year
Secondary outcomes (1)
Volumetric measurements
Volumetric assessment will be done by calculating both segmented condylar volumes (yielded from Conventional and Ultralow dose CBCT imaging) by the segmentation software in cubic millimeters.
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 posted1 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CBCT - Condyle - Semi-automated Segmentation - Ultra-low DoseStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. Human skulls and mandibles will be recruited according to the following eligibility criteria: inclusion criteria will be mandibles with sound condyles and skulls with sound glenoid fossa. Exclusion criteria will be skulls with fractured glenoid fossa, or glenoid fossa with developmental deformities, mandibles with fractured condylar neck or head, presence of pathological lesions, fracture, Shipping, or developmental deformities in the condyle.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Salib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441423
- Sponsor's protocol ID
- ORAD7-1-1-1
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)
- ClinicalTrials.gov ID
- NCT05441423
- Acronym / sponsor ID
- ORAD7-1-1-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 Jul 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.
The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine \& Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.
Detailed description
The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine \& Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.
R (Reference standard): Physical real linear measurements of the condyles will be considered as reference standard, where distances will be measured by digital caliper on the dry human in millimeters as supported by García-Sanz et al. (2017) \& (Kim et al., 2020).
Volumetric measurements form the dry human condyles will be considered as reference standard where water displacement method will be used (according to Archimedes' principle), by immersion of the condyle under investigation in a water filled graduated transparent glass container, after being hangered from a L-shaped metal hanger by using a rope, till the complete immersion of the condylar volume (which was demarcated by using the gutta percha points) under the water level, this will provide more standardization. Then, the displaced amount of water, will be observed and then aspirated by a graduated pipette to calculate its volume in cubic millimeters. This technique was supported by García-Sanz et al. (2017).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Model description
- Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. Human skulls and mandibles will be recruited according to the following eligibility criteria: inclusion criteria will be mandibles with sound condyles and skulls with sound glenoid fossa. Exclusion criteria will be skulls with fractured glenoid fossa, or glenoid fossa with developmental deformities, mandibles with fractured condylar neck or head, presence of pathological lesions, fracture, Shipping, or developmental deformities in the condyle.
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- mandibles with sound condyles
- skulls with sound glenoid fossa.
Key exclusion criteria (7 listed)
- skulls with fractured glenoid fossa,
- glenoid fossa with developmental deformities,
- mandibles with fractured condylar neck or head,
- presence of pathological lesions,
- fracture,
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 |
|---|---|---|
| CBCTCBCT Scans. conventional \& ultra low dose | Radiation | – |
Primary outcome
Linear Measurements
Time frame: 1 year
Linear assessment will be done by applying the same landmarks on the both segmented condyles (yielded rom Conventional and Ultralow dose CBCT imaging), Distances will be measured on the segmented condyles from the segmentation software in millimeters. The linear distances according to García-Sanz et al. (2017) will be as follows: * Line 1: Condylar width measured as the distance between lateral and medial landmarks. * Line 2: Condylar length measured as distance between anterior and posterior landmarks. * Line 3: Condylar height measured as distance of the perpendicular line traced from superior point to line 1.
1 secondary outcome
Volumetric measurements
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT in people with CBCT - Condyle - Semi-automated Segmentation - Ultra-low Dose, run by Cairo University.
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 2 inclusion and 7 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Linear Measurements (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 1 Jul 2022.