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Deep Learning Framework for Classification, 3D Segmentation & Visualization of C-shaped Canals (AI)

5 de julio de 2026 actualizado por: Mai Mohamed Safei Eldin Sayed, Cairo University

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?

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

112

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Develop a deep learning framework for Automated Segmentation, classification of C- shaped canals.
Periodo de tiempo: 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.
1-3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

5 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de julio de 2026

Publicado por primera vez (Actual)

13 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de julio de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AI in C-Shaped canals

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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