- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712160
Diagnostic Accuracy of Artificial Intelligence, CBCT, and Clinical Examination in Detecting Number of Root Canals in Conventional and Retreated Maxillary and Mandibular Molars
November 28, 2024 updated by: Misr International University
The study compares the effectiveness of Artificial Intelligence (AI), CBCT, and clinical examination in detecting root canals in upper first, upper second, and lower first molars.
Results show AI detects more molars with three or four canals in conventional treatment cases and retreatment cases.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Introduction: Accurate root canal detection is crucial for successful endodontic treatment, particularly in complex molar cases.
Conventional methods, such as clinical examination and cone-beam computed tomography (CBCT), have their limitations, as high radiation exposure.
Recent advancements in Artificial Intelligence (AI) have shown promise in improving diagnostic accuracy.
This study aims to compare the effectiveness of AI, CBCT, and clinical examination using a dental operating microscope (DOM) in detecting root canals in upper first, upper second, and lower first molars, in both conventional and retreatment cases.
Methods: CBCT scans from 210 patients requiring non-surgical root canal therapy or re-treatment were selected.
The scans were analyzed using three detection methods: clinical examination via DOM, interpretation by two experienced endodontists using CBCT, and an AI convolutional neural network (CNN) software (Diagnocat).
The detected number of root canals was recorded and compared across the three methods.
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 00202
- Misr International 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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male and female patients who were capable of providing informed consent
- Age between 18 to 40 years old.
- A restorable tooth.
Exclusion Criteria:
- Patients that underwent vital pulp therapies.
- Patients with calcifications in pulp space.
- Open apex/immature roots.
- Teeth restored by full coverage crowns.
- Pregnant women by taking adequate history from patient and pregnancy test that was done in the first visit
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBCT, Clinical using DOM
Comparing the three methods for the detection of the number of canals of maxillary and mandibular molars
|
The number of canals detected by AI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of canals detected
Time Frame: 1 day
|
The number of canals detected clinically using DOM, CBCT and by AI
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canal Morphology
Time Frame: 1 day
|
Canal morphology for successful and failed cases
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 20, 2023
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
February 20, 2024
Study Registration Dates
First Submitted
November 21, 2024
First Submitted That Met QC Criteria
November 28, 2024
First Posted (Estimated)
December 2, 2024
Study Record Updates
Last Update Posted (Estimated)
December 2, 2024
Last Update Submitted That Met QC Criteria
November 28, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
will be shared after publishing the paper
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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