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Missed CanalsNCT06325163

Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study

A study testing CBCT, clinical examination under dental operating microscope and canal detection AI software (diagnocat) in people with Missed Canals, run by Misr International University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Missed Canals
What is being tested?
CBCT, clinical examination under dental operating microscope and canal detection AI software (diagnocat)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteEgypt
Study dates
25 Jan 2023to 10 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and females.
  • Patients aged 18 to 40 years
  • Repairable permanent first molars in the lower jaw, with a closed apex, which required non-surgical retreatment.
  • One or more of the following signs and symptoms: Spontaneous pain, Pain on biting, Sinus tract, Radiolucency related to one or more roots.

Who cannot join

  • Patients with lower first molars which are deemed non restorable, or have large perforations, external resorption, or vertical root fracture,
  • Pregnant women
  • Immunocompromised patients.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Misr International University

    Cairo

Other trials in Egypt

About this study

evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging.

Read the detailed description

evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging.

  1. CBCT exmanation stage: In this stage, CBCT scanning was done using Soredex Cranex 3D Dental Imaging System, FINLAND, with the following parameters ((XS FOV dimensions 61 x 41 mm (HxD)) (XS FOV High resolution 90 kV / 4 - 12.5 mA / 6.1 s)). The samples will be randomized using randomization software (Microsoft Office Excel, USA) and will be assigned randomly to 2 endodontists who are unaware of the findings of stage 2. After interpreting and segmenting the CBCT scans in DICOM Format using OnDemand software (USA), the number of canals identified will be recorded on a pre-established information guide. The samples are coded based on the patient's file number, and the codes were undisclosed so that the CBCT examiners could not identify the samples. All images were interpreted from the axial section in the analysis of the tomographic sections, the number of canals are identified by the corresponding radiolucent orifices, regardless of their location along the root
  2. Clinical Stage: This is a clinical stage where the thirty-five patients, as predetermined by power analysis, will be randomly distributed upon 6 Practitioners using randomization software (Microsoft Office Excel). Practitioners will then proceed in access formation under dental operating microscope, (Leica M320D using magnification 16X, using fully integrated 4K camera). Access will be done using TR13 diamond stone (Mani, Japan) to remove caries and restorations. Troughing will be done using ultrasonic tip (NSK E4 and E15D) power 3W. Irrigation will be done using NAOCL (JK Dental Vision sodium hypochlorite, Egypt) with a concentration of 2.5%. Gutta percha will be removed from the canal using M-pro rotary files: At first orifice opener will be used to remove the coronal gutta percha then used the yellow file tapered 4% then confirm the working length by apex locator, after that using taper file 25 to remove the remaining gutta percha. DG16 endodontic probe (Dentsply Sirona, Germany) will be used to locate canal orifices. Upon confirmation by clinic PHD supervisors, the number of orifices found will be recorded on a pre-formed information guide, in one visit per patient. Access cavity will be aided by Leica M320D DOM
  3. Artificial intelligence stage: The carrying out of this stage will be solely undertaken by the principal investigator. The CBCT images will be uploaded to convolutional neural network software (CNN) that uses a deep learning algorithm and CBCT segmentation. The software will then record the number of canals it found

The software utilized employs deep convolutional neural networks (CNNs) with a specific U-net inspired structure. The complete CBCT scan is uploaded onto the software, where all collected images are analyzed and each tooth in the 3D scan is precisely located and assessed. The software uses pattern recognition and statistical predictions to segment numerous slices of each tooth and determine the condition or pathosis present. This is achieved by analyzing previously fed photos that were used to train the software

Conditions
Missed Canals
Being tested
CBCT, clinical examination under dental operating microscope, canal detection AI software (diagnocat)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBCTDiagnostic test

    Mandibular molar indicated for retreatment will be scanned using limited field of view CBCT to examine the number of canals

  • clinical examination under dental operating microscopeDiagnostic test

    the number of canals will be examined by an a randomly assigned operator following gutta percha removal under dental operating microscope

  • canal detection AI software (diagnocat)Diagnostic test

    software used to analyze CBCT images and report the number of canals

Study groups in NCT06325163
Study groupRoleWhat they receive
A single arm consisting of 3 stagesExperimentalThis study will include 3 stages: 1. CBCT examination stage: In this stage, CBCT scanning will be done and examined by by 2 blinded endodontists and the number of canals identified will be recorded 2. Clinical Stage: This is a clinical stage where patients will be randomly distributed upon 6 Practitioners using randomization software (Microsoft Office Excel). Practitioners will then proceed with the pretreatment procedures under dental operating microscope 3. Artificial intelligence stage: The carrying out of this stage will be solely undertaken by the principal investigator. The CBCT images will be uploaded to convolutional neural network software (CNN) that uses a deep learning algorithm and CBCT segmentation. The software will then record the number of canals it found
Receives: Diagnostic Test: CBCT; Diagnostic Test: clinical examination under dental operating microscope; Diagnostic Test: canal detection AI software (diagnocat)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of canals

    the numbers of canals in mandibular molars indicated for retreatment will be measured using CBCT, clinical under dental operating microscope, and using AI software

    Measured: The day of the procedure

Secondary outcomes (1)
  1. linear morphological variations in failed cases

    This outcome will measure I)Inter orifice distance II)Canal configuration. III)Width of the root, in millimeters

    Measured: Following the CBCT stage, an average of one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start25 Jan 2023
  3. Primary completion2 Oct 2023
  4. Study completion10 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06325163
Sponsor's protocol ID
MIU-IRB-2223-219
Status last verified
Mar 2024
First submitted
26 Dec 2023
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CBCT, clinical examination under dental operating microscope and canal detection AI software (diagnocat) in people with Missed Canals, run by Misr International University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of canals (time frame: The day of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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