Accuracy of Artificial Intelligence in Evaluation of the Relationship Between Mandibular Third Molar and Mandibular Canal on CBCT

April 22, 2022 updated by: Sally Mansour, Cairo University

Accuracy of Computer-aided Evaluation of the Relationship Between Mandibular Third Molar and Mandibular Canal on CBCT Images Using Deep Learning Model (Artificial Intelligence): Diagnostic Accuracy Study.

Convolutional neural network (CNN) are computer applications that assist in the detection and/or diagnosis of diseases by providing an unbiased "second opinion" to the image interpreter10, aiming at improving accuracy and reducing time for analysis. With the rapid growth of Deep Learning (DL) algorithms in image-based applications, CAD systems can now be trained by DL to provide more advanced capability (i.e., the capability of artificial intelligence [AI]) to best assist clinicians).

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The mandibular third molar extraction, considered one of the most common surgeries in oral and maxillofacial field, it can be associated with several postoperative complications, like pain, bleeding, swelling, and inferior alveolar nerve (IAN) injury or complete damage, impairing the quality of life of the affected patients. The incidence of temporary IAN injury caused by mandibular third molar extraction was 0.4-8.4%, while the incidence of permanent injury is less than 1% [1, 2]. However, due to the high occurrence of impacted mandibular third molar, a large number of patients suffer from IAN injury caused by impacted mandibular third molar extraction [3]. The most significant risk factor of IAN injury caused by mandibular third molar extraction is the proximity of the root of the mandibular third molar to the mandibular canal [1, 2, 4, 5]. So, comprehensive preoperative analysis and evaluation of the anatomical structures are essential before impacted mandibular third molar extraction to decrease the IAN injury risk.

The panoramic radiography is not that much accurate in displaying the relation between impacted mandibular third molar extraction and IAN due to the superimposition and inherent limitations. The accuracy of predicting the probability the (IAN) injury during the impacted mandibular third molar extraction using panoramic radiographs were controversial [6].

Cone beam computed tomography (CBCT), A (3D) imaging modality, provides accurate 3D information with decreased radiation dose than medical CT [7]. It was demonstrated that CBCT was a better and accurate radiographic method than panoramic radiography for evaluating the relationship between mandibular third molar and (IAN) [6, 8]. So that, CBCT has been considered as the modality of choice for preoperative assessment of complicated mandibular third molar extraction [9].

Deep learning, one of artificial intelligence subsets, had a rapid progression and has a significant role in medical fields. One of the deep learning models, guided learning of the convolutional neural network (CNN) is recently investigated, which has been proven to surpass human judgmental level in many medical imaging fields [12, 13]. After CNN was introduced to the maxillofacial field, it was used for the assessment, detection, categorization, and segmentation of the surrounding anatomical structures [14-18 Recently, deep learning based on CNN models has been used for the impacted mandibular third molar and mandibular canal detection and segmentation on panoramic radiographs and CBCT [15, 18, 30], the classification and staging of development [31, 32], and the approximation measurements of the impacted mandibular third molar on panoramic radiographs [33]. Fukuda et al. compared 3 CNNs for classification of the impacted mandibular third molar and mandibular canal relation with panoramic radiographs [34]. Yoo et al. proposed a CNN-based approach to assess the stalemate of the impacted mandibular third molar extraction using panoramic radiographs [35]. So, as mentioned before, panoramic radiography can't accurately describe the anatomical structures due to the superimposition that happens in the (2D) imaging modalities. Orhan et al. reported an AI application (Diagnocat, Inc.) based on CNN with high precision in detecting the M3 and assessment of the number of roots related to adjacent anatomical structures

Study Type

Observational

Enrollment (Anticipated)

50

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 Contact Backup

Study Locations

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The CBCT data of this study will be obtained from the CBCT data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt. CBCT scans of patients who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning will be included according to the proposed eligibility criteria.

Description

Inclusion Criteria:

  • • CBCT Scans showing Mandibular third molar of patients aging from 25 to 65 years old

    • The FOV should clearly show the third molar completely with its roots and the IAN.
    • Voxel size of 0.2mm.
    • Mandibular third molars. Absence of artifacts, dental implants in the adjacent teeth.

Exclusion Criteria:

  • • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the automatic evaluation of the relationship between mandibular third molar and the mandibular canal.
Time Frame: baseline
Accuracy of the deep learning model in automatic evaluation of mandibular third molar teeth and mandibular canal relationship.
baseline

Collaborators and Investigators

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

Investigators

  • Study Director: Enas Anter, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ORAD AI 1-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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