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NCT Number: NCT07315152

Validation of AI-Based Cephalometric Analysis in Orthodontics

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artificial Intelligence-Driven Cephalometric Analysis

Diagnostic Test

Cephalometric analysis performed using AI software, compared with manual tracings for validation of accuracy in orthodontic diagnosis and treatment planning.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamdi K Khalaf, BDs

CONTACT

[email protected]

201025135711

Noha S Mohammed, BDs

CONTACT

[email protected]

201148294667

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: AI-CEPH

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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