Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Pavia

About this trial

This study aims to evaluate the accuracy and reliability of artificial intelligence (AI)-based cephalometric analysis compared with digital manual tracing. A total of 100 standardized lateral cephalometric radiographs will be analyzed using Delta-Dent software with manual landmark identification and three fully automated AI-based systems (WebCeph, QuantX, and Smartee). Sagittal, vertical, dental, and soft tissue cephalometric parameters will be compared among the different methods. Statistical analysis will assess inter-method agreement and the clinical relevance of any observed discrepancies. The study seeks to determine whether AI-based systems provide measurements comparable to conventional digital tracing and whether they can be considered reliable adjunctive tools in orthodontic diagnosis and treatment planning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Availability of digital lateral cephalometric radiographs of adequate diagnostic quality

Radiographs acquired with patients in centric occlusion and proper head positioning using a cephalostat

Patients of any age and sex

Absence of congenital or acquired craniofacial anomalies

Disqualifiers

Radiographs presenting artifacts or inadequate visualization of anatomical structures

History of significant craniofacial trauma

Radiographs acquired without a cephalostat

Presence of severe skeletal asymmetries

Trial population

The study population consists of patients of any age and sex who underwent digital lateral cephalometric radiography as part of routine orthodontic diagnostic records at the Unit of Orthodontics and Paediatric Dentistry, University of Pavia. Radiographs meeting the predefined inclusion and exclusion criteria will be retrospectively selected for analysis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cephalometric Analysis

    Diagnostic test

    All included lateral cephalometric radiographs will undergo cephalometric analysis using both digital manual tracing and artificial intelligence-based automated systems. Manual digital tracing will be performed with Delta-Dent software by a single experienced orthodontist through manual identification of cephalometric landmarks. The same radiographs will subsequently be analysed using three fully automated AI-based software programs (WebCeph™, QuantX, and Smartee) without manual correction of landmark positioning. No therapeutic intervention or modification of patient treatment will be performed, as this is an observational comparative study based exclusively on retrospective analysis of radiographic records.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Orthodontic Patients with Lateral Cephalometric Radiographs1 intervention

Trial outcomes

Primary outcomes

1

Agreement between AI-based cephalometric analysis and digital manual tracing

Agreement between cephalometric measurements obtained with AI-based software systems and digital manual tracing will be assessed using the intraclass correlation coefficient (ICC) and differences in angular and linear cephalometric measurements.

Time frame
Baseline

Secondary outcomes

1

SNA

Time frame
Baseline
2

SNB

Time frame
Baseline
3

ANB

Time frame
Baseline
4

SN-GoGn

Time frame
Baseline

Other outcomes

Sponsors and contacts

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