NCT05340140

Brief Summary

CAD systems are computer applications that assist in the detection and/or diagnosis of diseases by providing an unbiased "second opinion" to the image interpreter, 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 (ie, the capability of artificial intelligence \[AI\]) to best assist clinicians.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

April 15, 2022

Last Update Submit

April 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of detection of MB2

    detection of MB2 on CBCT images of maxillary first molars using deep learning model

    baseline

Study Arms (1)

CBCT Images of Maxillary 1st molars

Diagnostic Test: deep learning model

Interventions

deep learning modelDIAGNOSTIC_TEST

deep learning model developed by computer science expert and based on convolution neural network , and trained by our datasets.

Also known as: artificial intelligence tool
CBCT Images of Maxillary 1st molars

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CBCT scans showing maxillary first molars with resolution not more than 0.1 mm voxel size.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 and from multiple private radiology centres using the same machine brand with the same parameters. CBCT scans of Egyptian patients who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning from January 2020 to December 2022 will be included according to the proposed eligibility criteria.

You may qualify if:

  • CBCT scans showing erupted maxillary 1st molar.
  • Vovel size not exceeding 0.1mm.
  • Maxillary molars showing complete root formation.
  • Carious or Non-carious tooth.

You may not qualify if:

  • Maxillary first 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry cairo university

Cairo, 12611, Egypt

RECRUITING

Related Publications (9)

  • Blattner TC, George N, Lee CC, Kumar V, Yelton CD. Efficacy of cone-beam computed tomography as a modality to accurately identify the presence of second mesiobuccal canals in maxillary first and second molars: a pilot study. J Endod. 2010 May;36(5):867-70. doi: 10.1016/j.joen.2009.12.023. Epub 2010 Feb 21.

    PMID: 20416435BACKGROUND
  • Kulild JC, Peters DD. Incidence and configuration of canal systems in the mesiobuccal root of maxillary first and second molars. J Endod. 1990 Jul;16(7):311-7. doi: 10.1016/s0099-2399(06)81940-0.

    PMID: 2081944BACKGROUND
  • Alacam T, Tinaz AC, Genc O, Kayaoglu G. Second mesiobuccal canal detection in maxillary first molars using microscopy and ultrasonics. Aust Endod J. 2008 Dec;34(3):106-9. doi: 10.1111/j.1747-4477.2007.00090.x.

    PMID: 19032644BACKGROUND
  • Gorduysus MO, Gorduysus M, Friedman S. Operating microscope improves negotiation of second mesiobuccal canals in maxillary molars. J Endod. 2001 Nov;27(11):683-6. doi: 10.1097/00004770-200111000-00008.

    PMID: 11716081BACKGROUND
  • Weine FS, Hayami S, Hata G, Toda T. Canal configuration of the mesiobuccal root of the maxillary first molar of a Japanese sub-population. Int Endod J. 1999 Mar;32(2):79-87. doi: 10.1046/j.1365-2591.1999.00186.x.

    PMID: 10371900BACKGROUND
  • Ekert T, Krois J, Meinhold L, Elhennawy K, Emara R, Golla T, Schwendicke F. Deep Learning for the Radiographic Detection of Apical Lesions. J Endod. 2019 Jul;45(7):917-922.e5. doi: 10.1016/j.joen.2019.03.016. Epub 2019 Jun 1.

    PMID: 31160078BACKGROUND
  • Hiraiwa T, Ariji Y, Fukuda M, Kise Y, Nakata K, Katsumata A, Fujita H, Ariji E. A deep-learning artificial intelligence system for assessment of root morphology of the mandibular first molar on panoramic radiography. Dentomaxillofac Radiol. 2019 Mar;48(3):20180218. doi: 10.1259/dmfr.20180218. Epub 2018 Nov 9.

    PMID: 30379570BACKGROUND
  • Orhan K, Bayrakdar IS, Ezhov M, Kravtsov A, Ozyurek T. Evaluation of artificial intelligence for detecting periapical pathosis on cone-beam computed tomography scans. Int Endod J. 2020 May;53(5):680-689. doi: 10.1111/iej.13265. Epub 2020 Feb 3.

    PMID: 31922612BACKGROUND
  • Mansour S, Anter E, Mohamed AK, Dahaba MM, Mousa A. Two step approach for detecting and segmenting the second mesiobuccal canal of maxillary first molars on cone beam computed tomography (CBCT) images via artificial intelligence. BMC Oral Health. 2025 Sep 8;25(1):1404. doi: 10.1186/s12903-025-06796-4.

Study Officials

  • Enas Anter, Ph.D

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofacial radiology, faculty of dentistry

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 21, 2022

Study Start

May 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations