- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07689708
AI Detection Model of Extra Root Canals in Mandibular Premolars Using CBCT Scans
Diagnostic Accuracy of a Deep Learning Model (Artificial Intelligence) for Detecting Extra Root Canals in Mandibular Premolars on CBCT Images: Diagnostic Accuracy Study.
Successful endodontic treatment depends on the complete identification and management of the entire root canal system. Missed root canals are a major cause of endodontic failure, particularly in mandibular premolars, which exhibit considerable anatomical variability and may contain additional root canals that are difficult to detect using conventional diagnostic methods.
Cone Beam Computed Tomography (CBCT) provides three-dimensional visualization of root canal anatomy and has significantly improved the detection of anatomical variations. However, interpretation of CBCT images remains dependent on the experience and expertise of the clinician, leading to potential observer variability and missed diagnoses.
Recent advances in artificial intelligence (AI), particularly deep learning models based on convolutional neural networks, have shown promising results in dental image analysis and diagnostic support. AI-assisted diagnostic systems may improve the accuracy, consistency, and efficiency of CBCT interpretation by automatically identifying complex anatomical structures.
The aim of this retrospective diagnostic accuracy study is to evaluate the performance of a newly developed deep learning model for the detection of extra root canals in mandibular premolars using CBCT images. The diagnostic accuracy of the AI model will be assessed by comparing its findings with the assessments of experienced oral and maxillofacial radiologists, which will serve as the reference standard.
A total of 272 CBCT scans of mandibular premolars from Egyptian patients will be included according to predefined eligibility criteria. Diagnostic performance will be evaluated using measures including sensitivity, specificity, positive predictive value, and negative predictive value.
The findings of this study may provide evidence regarding the clinical applicability of AI-assisted diagnostic tools in endodontics and contribute to improved detection of complex root canal anatomy, reduced incidence of missed canals, and enhanced treatment outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this observational study is to evaluate whether a deep learning artificial intelligence (AI) model can accurately detect extra root canals in mandibular premolars using Cone Beam Computed Tomography (CBCT) images in Egyptian patients. The main questions it aims to answer are:
- Can the AI model accurately detect extra root canals in mandibular premolars on CBCT scans?
- Is the diagnostic accuracy of the AI model comparable to that of experienced oral and maxillofacial radiologists? Researchers will compare the results generated by the AI model with the assessments of experienced radiologists, which will serve as the reference standard.
Participants will:
- Provide previously acquired CBCT scans that meet the study eligibility criteria.
- Have their CBCT images analyzed by the AI model.
- Have their CBCT images independently evaluated by experienced radiologists for comparison with the AI findings.
The study findings may help determine the potential role of AI-assisted diagnostic tools in improving the detection of complex root canal anatomy and supporting endodontic diagnosis
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayah Tarek, PHD candidate
- Phone Number: 20201221902479
- Email: ayahtarek94@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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 premolars showing complete root formation
- Carious or non-carious teeth
- Absence of artifacts.
Exclusion Criteria:
- Mandibular first and second premolars 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
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mandibular premolars with single canals
|
It is a study to detect the diagnostic accuracy of AI model to detect extra canals in mandibular premolars
|
|
Experimental: Mandibular premolars with more than one canal
|
It is a study to detect the diagnostic accuracy of AI model to detect extra canals in mandibular premolars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Accuracy of the Deep Learning Model for Detection of Extra Root Canals in Mandibular Premolars
Time Frame: During the procedure
|
Diagnostic accuracy of the AI model will be determined by comparison with expert radiologist assessment.
|
During the procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sensitivity of the AI Model Specificity of the AI Model Positive Predictive Value (PPV) Negative Predictive Value (NPV)
Time Frame: During the procedure
|
During the procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7.1.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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