Development and Diagnostic Accuracy of a Deep Learning Model for Root Canal Curvature Analysis in Mandibular Molars Using CBCT Scans: A Diagnostic Accuracy Study

May 8, 2026 updated by: Samaa Mohammed Osman Mohammed, Cairo University
Root canal preparation in endodontics poses significant challenges, particularly in curved canals of mandibular molars, where accurate preoperative assessment using CBCT imaging is crucial to avoid iatrogenic errors and improve treatment outcomes. This study aims to develop and evaluate the diagnostic accuracy of a deep learning model for analyzing root canal curvature angles in mandibular molars from CBCT scans, compared to human expert evaluations. The model will leverage advanced AI techniques to segment and measure curvatures objectively, addressing limitations in manual interpretation, potentially standardizing case difficulty assessments and aiding clinical decision-making.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The accepted sample size (n) will be 207, when the accuracy is (90.48%) and marginal error (4 %) by adopting confidence interval (95%), using Staskingdom calculator.

Description

Inclusion Criteria:

  • CBCT scans of mandibular molars of Egyptian patients aging from 18 to 65 years old
  • Small Field of view (FOV) including maximum a quadrant
  • Voxel size not larger than 2mm
  • Mandibular molars showing complete root formation
  • Carious or non-carious teeth
  • Absence of artifacts, dental implants in the adjacent teeth

Exclusion Criteria:

  • Mandibular first and second molars with developmental anomalies, external or internal root resorption, root canal calcification, previous root canal treatment, post restorations, and/or root caries
  • CBCT images of sub-optimal quality or artifacts/high scatter interfering with proper assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diagnostic test: Artificial intelligence
Reference group: Human Expert's opinion
Radiologist and Endodontist Human expert opinion compared to AI diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of analysis of root canal curvature angle
Time Frame: June 2026 to September 2027
Curvature analysis classified according to its severity into 3 categories: "10 degrees or less"; as mild, "between 10 to 30 degrees"; as moderate and "30 degrees or more"; as severe curvature.
June 2026 to September 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NEW Code 7-1-1
  • self funded (Other Identifier: Cairo University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study is diagnostic accuracy study on CBCT data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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