Validation of AI-Based Cephalometric Analysis in Orthodontics

NCT ID: NCT07315152

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-05-31

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malocclusion

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Patients undergoing routine cephalometric analysis, used to validate AI-driven measurements against manual tracings.

Artificial Intelligence-Driven Cephalometric Analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Hamdi Khalaf Ali

Principal Investigator (Master's Degree Researcher)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A Mohammed, DDs,phD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Faculty of Dentistry, Al-Azhar University

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hamdi K Khalaf, BDs

Role: CONTACT

201025135711

Noha S Mohammed, BDs

Role: CONTACT

201148294667

Facility Contacts

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Hamdi K Ali, BDs

Role: primary

201025135711

Noha S Mohammed, BDs

Role: backup

201148294667

References

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Kunz F, Stellzig-Eisenhauer A, Zeman F, Boldt J. Artificial intelligence in orthodontics : Evaluation of a fully automated cephalometric analysis using a customized convolutional neural network. J Orofac Orthop. 2020 Jan;81(1):52-68. doi: 10.1007/s00056-019-00203-8. Epub 2019 Dec 18.

Reference Type BACKGROUND
PMID: 31853586 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov

Scientific and biomedical literature related to orthodontics and artificial intelligence.

Other Identifiers

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AI-CEPH-VAL-01

Identifier Type: -

Identifier Source: org_study_id

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