NCT05538104

Brief Summary

A diagnostic accuracy study to assess the accuracy of a newly developed deep learning model in the automatic detection of periapical radiolucent lesions of upper and lower jaws by comparing it with experienced radiologists' opinion, which represents the ground truth. Hypothesis: The null hypothesis is that the results of the deep learning model are as accurate as the radiologists' opinion.

Trial Health

35
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 Sep 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

September 9, 2022

Last Update Submit

September 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • • Accuracy of automatic detection of periapical radiolucent lesions on CBCT images.

    * The computer generated deep learning model. * Well experienced radiologists' vision and interpretation of CBCT images in optimum viewing conditions. Using CBCT viewer software program Blue Sky Bio. unit : yes or no

    1year

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 and from available online data set with different CBCT machines. CBCT scans of Egyptian 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. .

You may qualify if:

  • CBCT scans of maxilla and mandible with good quality free pf periapical radiolucent lesions .
  • CBCT scans of maxilla and mandible with good quality showing periapical radiolucent lesions

You may not qualify if:

  • CBCT images of sub-optimal quality or artifacts / high scatter interfering with proper assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd candidate

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

September 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

September 13, 2022

Record last verified: 2022-09