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Not yet recruitingNCT07843992Updated Sep 28, 2026

AI-Based Root Canal Length, Curvature, and Morphology Assessment Using CBCT

An observational study in Root Canal, sponsored by Cairo University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
155
Sex
All
01

Study summary

The primary aim of this study is to develop, evaluate, and validate a deep learning-based software system capable of generating automated, comprehensive clinical reports that detect, segment, and quantify root canal curvature, total tooth length, and morphological configurations in maxillary and mandibular anterior and premolar teeth using Cone-Beam Computed Tomography (CBCT) datasets

Read the detailed description

Primary goal is to develop and validate the diagnostic performance metrics (e.g., Dice similarity coefficient, sensitivity, accuracy) of an artificial intelligence (AI)-driven tool; deep learning-based software system. That is capable of generating automated, comprehensive clinical reports based on: Automatic segmentation \& measurements of tooth length, root canal curvature, as well as segmentation and classifying morphological configurations in maxillary \& mandibular anterior \& premolar teeth using Cone-Beam Computed Tomography (CBCT) datasets.

It involves a two-phase workflow:

  • Development Phase: Deep learning models (like 3D U-Net architectures) are trained on a large, historically anonymized dataset of CBCT scans.
  • Validation Phase: To validate the model's segmentations, measurements and processing time for the automated clinical reports against expert reference standards of manual measurements performed by expert endodontists and oral and maxillofacial radiologists
02

Conditions studied

  • Root Canal

Keywords

  • Artificial Intelligence
  • deep learning
  • root canal
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pre-existing anonymized CBCT DICOM datasets of permanent maxillary and mandibular anterior and premolar teeth obtained from university hospitals and private centers. Eligible datasets will be retrospectively identified according to predefined inclusion and exclusion criteria and will be used for development, validation, and independent testing of the AI-based diagnostic system. No new imaging or intervention will be performed for the purpose of this study.

Inclusion criteria

  • Pre-existing CBCT DICOM datasets of maxillary \& mandibular anterior \& premolar teeth.
  • Permanent teeth with fully developed roots and completely formed apices.
  • High-quality CBCT scans with sufficient image resolution and minimal artifacts to permit accurate visualization of the root canal system.
  • Teeth with intact root canal anatomy suitable for automated analysis of root canal length, curvature, number of roots, number of root canals, and canal morphology.
  • Teeth representing a wide range of normal anatomical variations and root canal configurations to ensure adequate diversity for AI model development and validation.
  • DICOM datasets suitable for image preprocessing, annotation, and deep learning analysis.

Exclusion criteria

Exclusion Criteria:

  • Teeth with incomplete root formation or open apices.
  • Teeth that have undergone previous endodontic treatment, retreatment, apexification, regenerative endodontic procedures, or root-end surgery.
  • Teeth with extensive coronal destruction, large restorations, metallic posts, intracanal filling materials, or crowns that obscure the root canal anatomy.
  • Teeth with root fractures, perforations, internal or external root resorption, severe root dilacerations, or other conditions that interfere with accurate anatomical assessment.
  • Teeth associated with extensive periapical lesions, cysts, tumors, or other pathological conditions that significantly alter the normal root canal anatomy.
  • Teeth with developmental anomalies affecting root morphology, including fusion, gemination, dens invaginatus, dens evaginatus, taurodontism,
  • CBCT datasets with severe motion artifacts, beam-hardening artifacts, metallic artifacts, excessive image noise, or poor image quality that compromises accurate image analysis.
  • Duplicate or incomplete DICOM datasets, corrupted image files, or datasets unsuitable for AI processing.
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
155 participants (estimated)
Patient registry
No

Groups and cohorts

  • Anonymized CBCT Datasets

    Pre-existing anonymized CBCT DICOM datasets of maxillary and mandibular anterior and premolar teeth meeting the predefined eligibility criteria. The datasets will be used for development, validation, and independent testing of the deep learning-based system for automated assessment of root canal length, curvature, number of roots and canals, and root canal morphology. The independent validation set will include 155 selected teeth.

    Diagnostic Test: AI-Based Deep Learning System for Root Canal Assessment

Interventions

  • Diagnostic testAI-Based Deep Learning System for Root Canal Assessment

    A deep learning-based diagnostic system developed to automatically analyze anonymized CBCT DICOM datasets of maxillary and mandibular anterior and premolar teeth. The system performs automated tooth and root canal segmentation and assesses root canal length, curvature, number of roots and canals, and canal morphology. The AI-generated results will be compared with an expert-derived reference standard to evaluate diagnostic accuracy and agreement. The system also generates a standardized automated clinical report for each evaluated tooth.

05

What researchers measure

Primary outcomes

  1. Tooth-level diagnostic accuracy and agreement of the AI-based system for root canal anatomical assessment

    Diagnostic accuracy and agreement of the AI-based system will be assessed at the tooth level by comparing AI-generated measurements and classifications of root canal length, curvature, number of roots and canals, and canal morphology with the reference standard established by a panel of expert endodontists and oral and maxillofacial radiologists. Continuous and categorical outcomes will be evaluated using appropriate agreement and diagnostic accuracy measures.

    Time frame: through study completion, an average of 1 year

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Chen Z, Liu Q, Wang J, Ji N, Gong Y, Gao B. Tooth image segmentation and root canal measurement based on deep learning. Front Bioeng Biotechnol. 2025 Jun 9;13:1565403. doi: 10.3389/fbioe.2025.1565403. eCollection 2025. PubMed 40552111 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers because the study uses pre-existing anonymized CBCT DICOM datasets, and no plan has been established for external sharing of the individual-level data

08

Registry details

Key details

Study ID
NCT07843992
Lead sponsor
Cairo University
Responsible party
Eslam Fathy Bakhit Taha (Postgraduate student, Cairo University) — Principal investigator
First posted
Sep 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Eslam fathy, BDS
Contact
eslam.fathy@dentistry.cu.edu.eg
+201551682022
Ghada El-Hilaly Mohamed Eid, prof Dr
Contact
ghada.eid@dentistry.cu.edu.eg
+201001266608
Ghada El-Hilaly Mohamed Eid, Prof Dr
study chair · Cairo University
Eslam fathy, BDS
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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