Validation of AI-Based Cephalometric Analysis in Orthodontics (AI-CEPH)

January 3, 2026 updated by: Hamdi Khalaf Ali, Al-Azhar University

Validation of Artificial Intelligence-Driven Cephalometric Analysis as a Reliable Tool for Orthodontic Diagnosis and Treatment Planning

This study is designed to evaluate whether artificial intelligence can analyze cephalometric images in orthodontics as a reliable tool for diagnosis and treatment planning. The study will include orthodontic patients who need cephalometric evaluation. Participants will have their X-ray images analyzed using both the AI system and traditional manual methods. The study will compare the results to see how closely the AI measurements match the standard measurements. This information may help patients, families, and health care providers understand how AI can support orthodontic diagnosis and treatment planning.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cephalometric analysis is a fundamental diagnostic tool in orthodontics. Conventional manual tracing is time-consuming and operator-dependent, while artificial intelligence-based software has been introduced to improve efficiency and consistency.

This observational study will evaluate and compare manual and AI-assisted cephalometric analyses using lateral cephalometric radiographs. Selected angular and linear measurements will be assessed, and the agreement between the two methods will be statistically analyzed to determine accuracy and reliability.

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71524
        • Faculty of Dentistry, Al-Azhar University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed A Mohammed, DDs,phD

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

consists of orthodontic patients aged 12 to 40 years who require orthodontic diagnosis and treatment planning. Participants will have good-quality lateral cephalometric radiographs taken using standardized imaging protocols. The study includes both male and female patients with no previous orthodontic treatment.

Description

Inclusion Criteria:

  • No systemic disease.
  • Not receiving medical treatment that could interfere with bone metabolism.
  • Good level of oral hygiene.
  • No periodontal disease or radiographic evidence of bone loss.

Exclusion Criteria:

  • Periodontally compromised patients.
  • Presence of systemic diseases.
  • Drug dependencies.
  • Uncooperative patients.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients undergoing routine cephalometric analysis, used to validate AI-driven measurements against manual tracings.
Diagnostic test: Artificial Intelligence-Driven Cephalometric Analysis
Cephalometric analysis performed using AI software, compared with manual tracings for validation of accuracy in orthodontic diagnosis and treatment planning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of AI-driven cephalometric analysis
Time Frame: Day 1
Comparison of cephalometric measurements obtained using AI software with manual tracings to evaluate the accuracy and reliability of AI-driven analysis in orthodontic diagnosis.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Mohammed A Mohammed, DDs,phD, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-CEPH-VAL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision to share individual participant data has not yet been finalized. Considerations regarding participant confidentiality, data protection regulations, and ongoing study procedures may affect the ability to share IPD in the future.

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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