NCT07726290

Brief Summary

This retrospective validity study evaluates the accuracy of artificial intelligence (AI) in determining gender from mandibular morphometric linear measurements. The study utilizes pre-existing Cone Beam Computed Tomography (CBCT) scans of adult Egyptian dental patients. After automatic segmentation of the mandible from these scans, a radiologist will manually perform measurements from certain anatomical points. These measurements will be the reference standard for the AI models. A three-dimensional deep learning model will be developed to perform two tasks:

  1. 1.To identify the anatomical points and make the specified linear measurements from these points on the segmented mandibles
  2. 2.To accurately predict gender based on these measurements. (Main Objective) The primary objective of this study is to evaluate the accuracy of machine learning algorithms in gender identification from linear morphometric measurements of the mandible. The known gender from patient records will serve as the reference standard.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress18%
Jun 2026May 2027

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 24, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

July 19, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

gender predictiongender determinationmorphometric analysis of the mandiblemandible dimorphismartifical intelligencemachine learninglinear measurements of the mandible

Outcome Measures

Primary Outcomes (1)

  • Accuracy of AI in gender prediction

    The accuracy of machine learning models (Artificial Neural Networks and Logistic Regression) in gender prediction. The predictions results are compared to the known gender from patient records which serve as the reference standard. The measuring unit is categorical as male or female. Accuracy, Precision, Recall (sensitivity), Specificity, F1-score, and a Confusion matrix will be used to evaluate the prediction models.

    At study completion (at completion of analysis of the validation dataset) (12 months)

Secondary Outcomes (1)

  • Accuracy of AI in anatomical point placement and linear measurements

    At study completion (at completion of analysis of the validation dataset) (12 months)

Study Arms (1)

Pre-existing CBCT scans from adult Egyptian dental patients showing the mandible.

All scans within this cohort undergo the same automatic segmentation followed by expert landmark placement and measurement taking. Subsequently, these segmentations will be introduced to the AI model for automated landmark placement, measurements and finally gender prediction based on these measurements.

Eligibility Criteria

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

CBCT scans of patients, who have already been imaged for other treatment purposes, will be retrieved. Automatically segmented mandibles from these CBCT scans will be the population of the study.

You may qualify if:

  • Scans belonging to patients above or at the age of 18 years (≥ 18 years)
  • Scans that image the area of interest clearly (mandible) with a craniofacial or maxillomandibular field of view.
  • Good quality of the scan with no artefacts

You may not qualify if:

  • CBCT scans with significant artifacts (e.g. metal artefact) affecting visualization of the mandible
  • Congenital craniofacial anomalies affecting the mandibular anatomy
  • Large pathologies that affect the mandible's dimensions and cause significant bone loss.
  • Trauma to the mandible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Ola Mohamed Associate professor

    Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ashrakat Abdelmonem Habib, Master's candidate

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 24, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 24, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available to protect patient privacy and adhere to institutional ethical guidelines. All personal information will be removed, and the CBCT scans will be identified by an identification number. Publication of results will not reveal patient identity or allow identification of individuals. De-identified morphometric mandibular measurements and corresponding gender classifications may be made available upon reasonable request.

Locations