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Not yet recruitingNCT07315152AI-CEPHUpdated Jan 7, 2026

Validation of AI-Based Cephalometric Analysis in Orthodontics

An observational study in Malocclusion, sponsored by Al-Azhar University. Not yet recruiting at 1 site in Egypt. Open to participants aged 12 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
55
Ages
12 Years to 30 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Malocclusion

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Keywords

  • Treatment planing Orthodontics cephalometric analysis
03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 55 is below the median of 63 across 74 observational studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 30 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Periodontally compromised patients.
  • Presence of systemic diseases.
  • Drug dependencies.
  • Uncooperative patients.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
55 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients

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

    Diagnostic Test: Artificial Intelligence-Driven Cephalometric Analysis

Interventions

  • Diagnostic testArtificial Intelligence-Driven Cephalometric Analysis

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

06

What researchers measure

Primary outcomes

  1. Accuracy of AI-driven cephalometric analysis

    Comparison of cephalometric measurements obtained using AI software with manual tracings to evaluate the accuracy and reliability of AI-driven analysis in orthodontic diagnosis.

    Time frame: Day 1

07

Study locations

1 site
  • Faculty of Dentistry, Al-Azhar University
    Asyut, Asyut Governorate 71524, Egypt
08

References and documents

Publications

  • 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. PubMed 31853586 ↗

Individual participant data

Plan to share: Undecided — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Jun 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Jan 2, 2026
StartEst.
May 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2028
Last update
Jan 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07315152
Responsible party
Hamdi Khalaf Ali (Principal Investigator (Master's Degree Researcher), Al-Azhar University) — Principal investigator
First posted
Jan 2, 2026
Start date
May 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Jan 7, 2026

Study contacts

Hamdi K Khalaf, BDs
Contact
hamdikhalaf5@gmail.com
201025135711
Noha S Mohammed, BDs
Contact
nohaelkhateeb32@gmail.com
201148294667
Mohammed A Mohammed, DDs,phD
principal investigator · Al-Azhar University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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