C-shaped Root CanalAINCT07697378
Deep Learning Framework for Classification, 3D Segmentation & Visualization of C-shaped Canals
An observational study of C-shaped Root Canal, run by Cairo University.
Trial summary
The goal of this retrospective diagnostic accuracy study is to develop and validate a deep learning framework for the automated classification, three-dimensional (3D) segmentation, and visualization of C-shaped root canal anatomy using cone-beam computed tomography (CBCT) scans in adults with C-shaped root canals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- C-shaped Root Canal
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 1 Oct 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Retrospective collection of anonymized CBCT scans from the Faculty of Dentistry, Cairo University as well as private radiology service/ dental clinics and publicly available datasets.
Who may be able to join
- CBCT scans of C- shaped canals of patients aged 18 years or older, with satisfactory image quality, characterized by adequate sharpness, contrast and noise levels, enabling accurate delineation of pulp chambers and root canals. Additionally, the CBCT scans needed to have a field of view (FOV) covering the area of interest.
Who cannot join
- Patients younger than 18 years. CBCT scans with poor image quality (e.g., motion artifacts, excessive noise, low contrast, or beam hardening artifacts).
- Incomplete field of view that does not include the tooth of interest.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Accuracy of a Deep Learning Framework for Automated Classification, 3D Segmentation and Comprehensive Visualization of C-shaped Root Canal Architecture From Cone-Beam Computed Tomography
The goal of this retrospective diagnostic accuracy study is to develop and validate a deep learning framework for the automated classification, three-dimensional (3D) segmentation, and visualization of C-shaped root canal anatomy using cone-beam computed tomography (CBCT) scans in adults with C-shaped root canals.
The main questions it aims to answer are:
Can a deep learning model accurately classify C-shaped root canal configurations from CBCT images? Can the model precisely segment the complex 3D anatomy of C-shaped root canals, including fins, webs, and isthmuses, with accuracy comparable to expert endodontists? Can the automated framework improve the efficiency and clinical utility of diagnosing and visualizing C-shaped root canal anatomy?
Read the detailed description
The framework is designed to identify C-shaped canal configurations and accurately segment their complex anatomical features, including fins, webs, and isthmuses.
Index test:
Deep Learning Model Design for Automated Classification and Segmentation
Stage 1: Tooth Localization:
- Objective: To identify and segment the target molar (primarily mandibular second molars) from the full CBCT volume.
- Architecture: An Attention U-Net based architecture will be explored, known for its ability to focus on important regions and efficiently process dental descriptors.
- Output: A cropped Region of Interest (ROI) containing the tooth of interest, reducing computational load for subsequent stages.
Stage 2: C-shaped Root Canal Architecture Classification and Segmentation:
- Objective: To precisely delineate the C-shaped root canal system, including the main canal lumen, fins, webs, and isthmuses, and to classify its specific type (e.g., C1, C2, C3, C4, C5) based on established criteria (e.g., Fan's classification).
- Architecture: Advanced 3D U-Net variants will be explored, given their proven efficacy in medical image segmentation and ability to capture fine details.
- Optimization: Models will be trained using robust optimizers (e.g., ADAM) with a managed learning rate schedule. Early stopping criteria will be implemented based on validation set performance to prevent overfitting. 3D Reconstruction and Advanced Visualization Pipeline 3D Model Generation:
- Conversion: Segmented 3D masks will be converted into standard 3D file formats, such as Standard Triangle Language (STL), ensuring interoperability with various software and 3D printing platforms.
Interactive Visualization Development:
● Software/Libraries: Open-source libraries like Open3D will be explored for interactive rendering and development of clinical utility features.
Performance Evaluation and Validation
Quantitative Metrics:
- Segmentation: Dice Similarity Coefficient (DSC), Hausdorff Distance (HD) and Intersection over Union (IoU) will be used to assess spatial overlap and boundary agreement.
- Classification: Accuracy, Precision, Recall, F1-score, and Area Under the Curve (AUC) will evaluate the model's ability to correctly categorize C-shaped canal types.
Clinical Utility and Efficiency Assessment:
- Qualitative Evaluation: Experienced endodontists will qualitatively assess the practical applicability and accuracy of the segmented 3D models for diagnosis, treatment planning, and identification of critical anatomical features.
- Time Efficiency: The time efficiency of the automated framework will be measured and compared to manual segmentation processes.
Reference standard:
- Expert Annotation: Manual classification and segmentation will be performed by multiple experienced endodontists or dental-maxillofacial radiologists, establishing the "gold standard" ground truth for the dataset. Full manual 3D segmentation, including the intricate architectural features, will be meticulously performed using 3D Slicer software. For 2D annotations, such as those for initial classification tasks or specific cross-sectional views, Roboflow will be utilized.
- Inter-observer Variability: Inter-observer variability among annotators will be assessed to ensure the consistency and quality of the ground truth.
- Conditions
- C-shaped Root Canal
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a deep learning framework for Automated Segmentation, classification of C- shaped canals.
An Attention U-Net based architecture will be explored, known for its ability to focus on important regions and efficiently process dental descriptors.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start5 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C-shaped Root CanalStudies 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Safei Eldin Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697378
- Sponsor's protocol ID
- AI in C-Shaped canals
- Acronym
- AI
- Status last verified
- Mar 2026
- First submitted
- 5 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of a Deep Learning Framework for Automated Classification, 3D Segmentation and Comprehensive Visualization of C-shaped Root Canal Architecture From Cone-Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT07697378
- Acronym / sponsor ID
- AI / AI in C-Shaped canals
- Conditions
- C-shaped Root Canal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 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.
The goal of this retrospective diagnostic accuracy study is to develop and validate a deep learning framework for the automated classification, three-dimensional (3D) segmentation, and visualization of C-shaped root canal anatomy using cone-beam computed tomography (CBCT) scans in adults with C-shaped root canals.
The main questions it aims to answer are:
Can a deep learning model accurately classify C-shaped root canal configurations from CBCT images? Can the model precisely segment the complex 3D anatomy of C-shaped root canals, including fins, webs, and isthmuses, with accuracy comparable to expert endodontists? Can the automated framework improve the efficiency and clinical utility of diagnosing and visualizing C-shaped root canal anatomy?
Detailed description
The framework is designed to identify C-shaped canal configurations and accurately segment their complex anatomical features, including fins, webs, and isthmuses.
Index test:
Deep Learning Model Design for Automated Classification and Segmentation
Stage 1: Tooth Localization:
- Objective: To identify and segment the target molar (primarily mandibular second molars) from the full CBCT volume.
- Architecture: An Attention U-Net based architecture will be explored, known for its ability to focus on important regions and efficiently process dental descriptors.
- Output: A cropped Region of Interest (ROI) containing the tooth of interest, reducing computational load for subsequent stages.
Stage 2: C-shaped Root Canal Architecture Classification and Segmentation:
- Objective: To precisely delineate the C-shaped root canal system, including the main canal lumen, fins, webs, and isthmuses, and to classify its specific type (e.g., C1, C2, C3, C4, C5) based on established criteria (e.g., Fan's classification).
- Architecture: Advanced 3D U-Net variants will be explored, given their proven efficacy in medical image segmentation and ability to capture fine details.
- Optimization: Models will be trained using robust optimizers (e.g., ADAM) with a managed learning rate schedule. Early stopping criteria will be implemented based on validation set performance to prevent overfitting. 3D Reconstruction and Advanced Visualization Pipeline 3D Model Generation:
- Conversion: Segmented 3D masks will be converted into standard 3D file formats, such as Standard Triangle Language (STL), ensuring interoperability with various software and 3D printing platforms.
Interactive Visualization Development:
● Software/Libraries: Open-source libraries like Open3D will be explored for interactive rendering and development of clinical utility features.
Performance Evaluation and Validation
Quantitative Metrics:
- Segmentation: Dice Similarity Coefficient (DSC), Hausdorff Distance (HD) and Intersection over Union (IoU) will be used to assess spatial overlap and boundary agreement.
- Classification: Accuracy, Precision, Recall, F1-score, and Area Under the Curve (AUC) will evaluate the model's ability to correctly categorize C-shaped canal types.
Clinical Utility and Efficiency Assessment:
- Qualitative Evaluation: Experienced endodontists will qualitatively assess the practical applicability and accuracy of the segmented 3D models for diagnosis, treatment planning, and identification of critical anatomical features.
- Time Efficiency: The time efficiency of the automated framework will be measured and compared to manual segmentation processes.
Reference standard:
- Expert Annotation: Manual classification and segmentation will be performed by multiple experienced endodontists or dental-maxillofacial radiologists, establishing the "gold standard" ground truth for the dataset. Full manual 3D segmentation, including the intricate architectural features, will be meticulously performed using 3D Slicer software. For 2D annotations, such as those for initial classification tasks or specific cross-sectional views, Roboflow will be utilized.
- Inter-observer Variability: Inter-observer variability among annotators will be assessed to ensure the consistency and quality of the ground truth.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Retrospective collection of anonymized CBCT scans from the Faculty of Dentistry, Cairo University as well as private radiology service/ dental clinics and publicly available datasets.
Key inclusion criteria (1 listed)
- CBCT scans of C- shaped canals of patients aged 18 years or older, with satisfactory image quality, characterized by adequate sharpness, contrast and noise levels, enabling accurate delineation of pulp chambers and root canals. Additionally, the CBCT scans needed to have a field of view (FOV) covering the area of interest.
Key exclusion criteria (2 listed)
- Patients younger than 18 years. CBCT scans with poor image quality (e.g., motion artifacts, excessive noise, low contrast, or beam hardening artifacts).
- Incomplete field of view that does not include the tooth of interest.
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
Develop a deep learning framework for Automated Segmentation, classification of C- shaped canals.
Time frame: 1-3 months
An Attention U-Net based architecture will be explored, known for its ability to focus on important regions and efficiently process dental descriptors.
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of C-shaped Root Canal, 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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?
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 Mai Mohamed Safei Eldin Sayed, PhD candidate (0201101733332, Mai.safei@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a deep learning framework for Automated Segmentation, classification of C- shaped canals. (time frame: 1-3 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 13 Jul 2026.