GenderNCT07726290
Validating AI for Gender Prediction Using Morphometric Analysis of the Mandible
An observational study of Gender and MANDIBLE, run by Cairo University at 1 site in Egypt.
Trial summary
This retrospective validity study evaluates the accuracy of artificial intelligence (AI) in determining gender from mandibular morphometric linear measurements. The study utilizes pre-existing Cone Beam Computed Tomography (CBCT) scans of adult Egyptian dental patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender, MANDIBLE, Forensic Dentistry
- How many people
- 385 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: CBCT scans of patients, who have already been imaged for other treatment purposes, will be retrieved. Automatically segmented mandibles from these CBCT scans will be the population of the study.
Who may be able to join
- Scans belonging to patients above or at the age of 18 years (≥ 18 years)
- Scans that image the area of interest clearly (mandible) with a craniofacial or maxillomandibular field of view.
- Good quality of the scan with no artefacts
Who cannot join
- CBCT scans with significant artifacts (e.g. metal artefact) affecting visualization of the mandible
- Congenital craniofacial anomalies affecting the mandibular anatomy
- Large pathologies that affect the mandible's dimensions and cause significant bone loss.
- Trauma to the mandible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashrakat Abdelmonem Habib, Master's candidate contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Ashrakat Abdelmonem Habib, Master's Candidate, +201146752225, ashrakat.habib@dentistry.cu.edu.eg
About this study
Official title: The Accuracy of Artificial Intelligence in Gender Prediction Using Morphometric Analysis of the Mandible - a Validity Study
This retrospective validity study evaluates the accuracy of artificial intelligence (AI) in determining gender from mandibular morphometric linear measurements. The study utilizes pre-existing Cone Beam Computed Tomography (CBCT) scans of adult Egyptian dental patients. After automatic segmentation of the mandible from these scans, a radiologist will manually perform measurements from certain anatomical points. These measurements will be the reference standard for the AI models.
A three-dimensional deep learning model will be developed to perform two tasks:
Read more
- To identify the anatomical points and make the specified linear measurements from these points on the segmented mandibles
- To accurately predict gender based on these measurements. (Main Objective) The primary objective of this study is to evaluate the accuracy of machine learning algorithms in gender identification from linear morphometric measurements of the mandible. The known gender from patient records will serve as the reference standard.
This study will assess the reliability of AI as an objective tool for gender determination for forensic purposes.
Read the detailed description
Study Overview and Objective:
- To evaluate the accuracy of machine learning algorithms (ANN and logistic regression) in gender identification from linear morphometric measurements of the mandible. These measurements will be derived from automated mandibular segmentations from CBCT scans of a sample of Egyptian dental patients. The AI model's accuracy, precision, and sensitivity (recall) will be assessed. The model's predictions will be compared to the known gender from patient records.
- To evaluate the accuracy of AI (3D UNet) in anatomical point identification and linear measurement. The model's performance will be compared to the radiologist's manual point placement and measurements.
Rationale:
Gender identification is vital in forensic odontology as it makes individual identification easier and faster. Artificial Intelligence can improve accuracy, speed, and efficiency in gender identification processes. The mandible is a sturdy bone with dimorphic features that can aid in gender determination even if other bones are lost. Cone beam computed tomography (CBCT) provides accurate 3D images and therefore accurate measurements. Linear morphometric measurements of the mandible derived from CBCT will provide an objective way of gender determination. AI algorithms can use these measurements to predict gender. Evaluating the accuracy of artificial intelligence in gender determination using morphometric measurements from CBCT-based mandibular segmentations is therefore essential to assess its reliability and potential value as an objective diagnostic tool in forensic practice.
Data Source and Population: Pre-existing, anonymized CBCT scans will be retrieved from the archives of the Oral and Maxillofacial Radiology clinic at the Faculty of Dentistry, Cairo University.
Sample Size Calculation The sample size was calculated to be 385 CBCT DICOMs using the Stats Kingdom statistical tool, based on the primary outcome - accuracy of AI in gender prediction. The power of study was 0.8, the margin of error was 0.04 and the alpha level of significance was 0.05.
Methodology:
Reference standard:
After recruiting a scan in the study, the name of the patient will be removed, and the scan will be given an identification number instead. One of the supervisors will have a dataset with the identification number, age, and the correct gender written before all personal information is erased from the CBCT scan. This will ensure that the radiologist performing the morphometric measurements will be blinded.
The DICOM file will be opened in 3D slicer imaging software (version 5.10.0; MIT, Cambridge, MA, USA) where automatic segmentation of the mandible will be peformed.
The radiologist performing the measurements has 2 years of experience. The following linear measurements will be performed: bi-coronoid width, bi-condylar width, distance from right gonion to menton and left gonion to menton, and distance from right coronoid to right gonion and left coronoid to left gonion.These measurements will be written in a separate dataset with the identification number of the scan with no information about the gender. Interobserver agreement will be validated by a senior radiologist (>15 years experience) who will re-evaluate a 30% sample of the cases. The datasets will be sent to a statistician to assess the normality of data and sexual dimorphism.
The segmented mandibles (NRRD files) and the measurement files (JSON files) will be saved for each case to be introduced in the AI model by the AI engineer.
Index test:
A three-dimensional deep learning model will be developed to perform two tasks:
- To identify the anatomical points and make the specified linear measurements from these points on the segmented mandibles
- To accurately predict gender based on these measurements The AI engineer will be responsible for model implementation. For the first task, 3D U-Net model will be employed. The NRRD and JSON files will be introduced to the model for training and testing. For the second task, Artificial neural networks and logistic regression will be used.
Data preprocessing will be performed and the dataset will be divided into training, validation, and testing subsets to ensure balanced and unbiased evaluation. K-fold cross-validation will be used if sample size is small.
Training:
The landmark detection model will be trained using supervised learning techniques .The classification models will subsequently be trained using the extracted feature representations. Each model will be trained using the same training data and preprocessing pipeline.
Testing:
In the testing phase, the trained system will process unseen segmented mandibles to automatically localize keypoints, compute relevant geometric features, and generate gender predictions without further model updates.
Evaluation and Expected Outcome:
Model performance will be evaluated using quantitative localization error metrics for keypoint detection and standard classification metrics for gender prediction.
Statistical Analysis:
Statistical tests will be applied to assess the normality of data and sexual dimorphism of the linear morphometric mandibular measurements before introducing these measurements to the AI model. Mean Euclidean Distance Error (in millimeters), and Root Mean Square Error (RMSE) will be used to assess the accuracy of the model in anatomical point placement in comparison to the radiologist's measurements. Accuracy, Precision, Recall (sensitivity), Specificity, F1-score, and a Confusion matrix will be used to evaluate the prediction models.
No data will be missed considering the retrospective nature of the study
- Conditions
- Gender, MANDIBLE, Forensic Dentistry, Morphometric Analysis, Artifical Intelligence, Gender Prediction
- Keywords
- gender prediction, gender determination, morphometric analysis of the mandible, mandible dimorphism, artifical intelligence, machine learning, linear measurements of the mandible
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-existing CBCT scans from adult Egyptian dental patients showing the mandible. | All scans within this cohort undergo the same automatic segmentation followed by expert landmark placement and measurement taking. Subsequently, these segmentations will be introduced to the AI model for automated landmark placement, measurements and finally gender prediction based on these measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI in gender prediction
The accuracy of machine learning models (Artificial Neural Networks and Logistic Regression) in gender prediction. The predictions results are compared to the known gender from patient records which serve as the reference standard. The measuring unit is categorical as male or female.
Accuracy, Precision, Recall (sensitivity), Specificity, F1-score, and a Confusion matrix will be used to evaluate the prediction models.
Measured: At study completion (at completion of analysis of the validation dataset) (12 months)
Secondary outcomes (1)
Accuracy of AI in anatomical point placement and linear measurements
Landmark placement and linear measurments of 3D UNet model versus radiologists' manual measurements will be compared. The measuring unit will be in millimeters (mm).
Mean Euclidean Distance Error (in millimeters), and Root Mean Square Error (RMSE) will be used to assess the accuracy of the model in anatomical point placement in comparison to the radiologist's measurements
Measured: At study completion (at completion of analysis of the validation dataset) (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Jun 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashrakat Abdelmonem Mohamed Mohamed Habib, Cairo University
- Investigators
- Ola Mohamed Associate professor, Study director, Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726290
- Sponsor's protocol ID
- OMFR 8-1-2 (2026)
- Status last verified
- May 2026
- First submitted
- 19 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect patient privacy and adhere to institutional ethical guidelines. All personal information will be removed, and the CBCT scans will be identified by an identification number. Publication of results will not reveal patient identity or allow identification of individuals. De-identified morphometric mandibular measurements and corresponding gender classifications may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Artificial Intelligence in Gender Prediction Using Morphometric Analysis of the Mandible - a Validity Study
- ClinicalTrials.gov ID
- NCT07726290
- Acronym / sponsor ID
- OMFR 8-1-2 (2026)
- Conditions
- Gender, MANDIBLE, Forensic Dentistry, Morphometric Analysis, Artifical Intelligence, Gender Prediction
- Keywords
- gender prediction, gender determination, morphometric analysis of the mandible, mandible dimorphism, artifical intelligence, machine learning, linear measurements of the mandible
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
This retrospective validity study evaluates the accuracy of artificial intelligence (AI) in determining gender from mandibular morphometric linear measurements. The study utilizes pre-existing Cone Beam Computed Tomography (CBCT) scans of adult Egyptian dental patients. After automatic segmentation of the mandible from these scans, a radiologist will manually perform measurements from certain anatomical points. These measurements will be the reference standard for the AI models.
A three-dimensional deep learning model will be developed to perform two tasks:
- To identify the anatomical points and make the specified linear measurements from these points on the segmented mandibles
- To accurately predict gender based on these measurements. (Main Objective) The primary objective of this study is to evaluate the accuracy of machine learning algorithms in gender identification from linear morphometric measurements of the mandible. The known gender from patient records will serve as the reference standard.
This study will assess the reliability of AI as an objective tool for gender determination for forensic purposes.
Detailed description
Study Overview and Objective:
- To evaluate the accuracy of machine learning algorithms (ANN and logistic regression) in gender identification from linear morphometric measurements of the mandible. These measurements will be derived from automated mandibular segmentations from CBCT scans of a sample of Egyptian dental patients. The AI model's accuracy, precision, and sensitivity (recall) will be assessed. The model's predictions will be compared to the known gender from patient records.
- To evaluate the accuracy of AI (3D UNet) in anatomical point identification and linear measurement. The model's performance will be compared to the radiologist's manual point placement and measurements.
Rationale:
Gender identification is vital in forensic odontology as it makes individual identification easier and faster. Artificial Intelligence can improve accuracy, speed, and efficiency in gender identification processes. The mandible is a sturdy bone with dimorphic features that can aid in gender determination even if other bones are lost. Cone beam computed tomography (CBCT) provides accurate 3D images and therefore accurate measurements. Linear morphometric measurements of the mandible derived from CBCT will provide an objective way of gender determination. AI algorithms can use these measurements to predict gender. Evaluating the accuracy of artificial intelligence in gender determination using morphometric measurements from CBCT-based mandibular segmentations is therefore essential to assess its reliability and potential value as an objective diagnostic tool in forensic practice.
Data Source and Population: Pre-existing, anonymized CBCT scans will be retrieved from the archives of the Oral and Maxillofacial Radiology clinic at the Faculty of Dentistry, Cairo University.
Sample Size Calculation The sample size was calculated to be 385 CBCT DICOMs using the Stats Kingdom statistical tool, based on the primary outcome - accuracy of AI in gender prediction. The power of study was 0.8, the margin of error was 0.04 and the alpha level of significance was 0.05.
Methodology:
Reference standard:
After recruiting a scan in the study, the name of the patient will be removed, and the scan will be given an identification number instead. One of the supervisors will have a dataset with the identification number, age, and the correct gender written before all personal information is erased from the CBCT scan. This will ensure that the radiologist performing the morphometric measurements will be blinded.
The DICOM file will be opened in 3D slicer imaging software (version 5.10.0; MIT, Cambridge, MA, USA) where automatic segmentation of the mandible will be peformed.
The radiologist performing the measurements has 2 years of experience. The following linear measurements will be performed: bi-coronoid width, bi-condylar width, distance from right gonion to menton and left gonion to menton, and distance from right coronoid to right gonion and left coronoid to left gonion.These measurements will be written in a separate dataset with the identification number of the scan with no information about the gender. Interobserver agreement will be validated by a senior radiologist (>15 years experience) who will re-evaluate a 30% sample of the cases. The datasets will be sent to a statistician to assess the normality of data and sexual dimorphism.
The segmented mandibles (NRRD files) and the measurement files (JSON files) will be saved for each case to be introduced in the AI model by the AI engineer.
Index test:
A three-dimensional deep learning model will be developed to perform two tasks:
- To identify the anatomical points and make the specified linear measurements from these points on the segmented mandibles
- To accurately predict gender based on these measurements The AI engineer will be responsible for model implementation. For the first task, 3D U-Net model will be employed. The NRRD and JSON files will be introduced to the model for training and testing. For the second task, Artificial neural networks and logistic regression will be used.
Data preprocessing will be performed and the dataset will be divided into training, validation, and testing subsets to ensure balanced and unbiased evaluation. K-fold cross-validation will be used if sample size is small.
Training:
The landmark detection model will be trained using supervised learning techniques .The classification models will subsequently be trained using the extracted feature representations. Each model will be trained using the same training data and preprocessing pipeline.
Testing:
In the testing phase, the trained system will process unseen segmented mandibles to automatically localize keypoints, compute relevant geometric features, and generate gender predictions without further model updates.
Evaluation and Expected Outcome:
Model performance will be evaluated using quantitative localization error metrics for keypoint detection and standard classification metrics for gender prediction.
Statistical Analysis:
Statistical tests will be applied to assess the normality of data and sexual dimorphism of the linear morphometric mandibular measurements before introducing these measurements to the AI model. Mean Euclidean Distance Error (in millimeters), and Root Mean Square Error (RMSE) will be used to assess the accuracy of the model in anatomical point placement in comparison to the radiologist's measurements. Accuracy, Precision, Recall (sensitivity), Specificity, F1-score, and a Confusion matrix will be used to evaluate the prediction models.
No data will be missed considering the retrospective nature of the study
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-existing CBCT scans from adult Egyptian dental patients showing the mandible. | – | –All scans within this cohort undergo the same automatic segmentation followed by expert landmark placement and measurement taking. Subsequently, these segmentations will be introduced to the AI model for automated landmark placement, measurements and finally gender prediction based on these measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- CBCT scans of patients, who have already been imaged for other treatment purposes, will be retrieved. Automatically segmented mandibles from these CBCT scans will be the population of the study.
Key inclusion criteria (3 listed)
- Scans belonging to patients above or at the age of 18 years (≥ 18 years)
- Scans that image the area of interest clearly (mandible) with a craniofacial or maxillomandibular field of view.
- Good quality of the scan with no artefacts
Key exclusion criteria (4 listed)
- CBCT scans with significant artifacts (e.g. metal artefact) affecting visualization of the mandible
- Congenital craniofacial anomalies affecting the mandibular anatomy
- Large pathologies that affect the mandible's dimensions and cause significant bone loss.
- Trauma to the mandible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of AI in gender prediction
Time frame: At study completion (at completion of analysis of the validation dataset) (12 months)
The accuracy of machine learning models (Artificial Neural Networks and Logistic Regression) in gender prediction. The predictions results are compared to the known gender from patient records which serve as the reference standard. The measuring unit is categorical as male or female. Accuracy, Precision, Recall (sensitivity), Specificity, F1-score, and a Confusion matrix will be used to evaluate the prediction models.
1 secondary outcome
Accuracy of AI in anatomical point placement and linear measurements
Time frame: At study completion (at completion of analysis of the validation dataset) (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect patient privacy and adhere to institutional ethical guidelines. All personal information will be removed, and the CBCT scans will be identified by an identification number. Publication of results will not reveal patient identity or allow identification of individuals. De-identified morphometric mandibular measurements and corresponding gender classifications may be made available upon reasonable request.
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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.
Ashrakat Abdelmonem Habib, Master's candidate contact
Ola Mohamed Associate professor study director
Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University
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 Gender and MANDIBLE, 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 4 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashrakat Abdelmonem Habib, Master's candidate (+201146752225, ashrakat.habib@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AI in gender prediction (time frame: At study completion (at completion of analysis of the validation dataset) (12 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 24 Jul 2026.