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Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing

Cephalometric Tracing: A Comparison Between Digital Analysis and Artificial Intelligence

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07664488
Enrollment
100
Registered
2026-06-24
Start date
2026-06-01
Completion date
2026-09-30
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence (AI), Artificial Intelligence (AI) in Diagnosis, Cephalometric Analysis, Cephalometry

Keywords

artificial intelligence, cephalometric analysis, lateral cephalogram, landmark identification, automated cephalometric tracing

Brief summary

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.

Detailed description

This prospective observational study aims to evaluate the accuracy, reproducibility, and clinical reliability of artificial intelligence (AI)-based cephalometric analysis systems compared with digital manual tracing. Patients whose lateral cephalometric radiographs were previously acquired for orthodontic diagnostic purposes at the Unit of Orthodontics and Paediatric Dentistry, University of Pavia, will be retrospectively selected according to predefined inclusion and exclusion criteria. Written informed consent for the use of clinical records for research purposes will be obtained from all participants or their legal guardians. A total of 100 standardized digital lateral cephalometric radiographs will be included in the study. Each radiograph will be analysed using Delta-Dent software with manual landmark identification and three fully automated AI-based software systems: WebCeph™, QuantX, and Smartee. Cephalometric analyses will be performed without manual adjustment of landmarks in the AI-based systems. Ten cephalometric parameters representative of sagittal, vertical, dental, and soft tissue relationships will be evaluated, including SNA, SNB, ANB, SN-GoGn, L1-GoGn, U1-ANSPNS, nasolabial angle, facial angle, Wits appraisal, and N-Me. Manual digital tracing performed by a single experienced orthodontist will be considered the reference method. Intra-rater reliability will be assessed using intraclass correlation coefficient (ICC). Statistical analysis will be conducted using R software (version 3.1.3; R Foundation for Statistical Computing, Wien, Austria). Descriptive statistics will be calculated for all variables. Normality of data distribution will be assessed using the Kolmogorov-Smirnov test. Comparisons among the different methods will be performed using the Friedman test followed by Dunn's post hoc test. Statistical significance will be predetermined at p \< 0.05.

Interventions

DIAGNOSTIC_TESTCephalometric Analysis

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.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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 * No previous orthodontic treatment * No previous orthognathic surgical treatment * Absence of agenesis of incisors or first molars * Absence of supernumerary teeth overlapping the region of interest

Exclusion criteria

* Radiographs presenting artifacts or inadequate visualization of anatomical structures * History of significant craniofacial trauma * Radiographs acquired without a cephalostat * Presence of severe skeletal asymmetries * Incomplete clinical or radiographic records * Radiographs unsuitable for manual or AI-based cephalometric landmark identification

Design outcomes

Primary

MeasureTime frameDescription
Agreement between AI-based cephalometric analysis and digital manual tracingBaselineAgreement 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.

Secondary

MeasureTime frame
SNABaseline
SNBBaseline
ANBBaseline
SN-GoGnBaseline
L1-GoGnBaseline
U1-ANSPNSBaseline
Nasolabial angleBaseline
Facial angleBaseline
Wits appraisalBaseline
N-MeBaseline

Countries

Italy

Contacts

CONTACTAndrea Scribante, DDS, PhD
andrea.scribante@unipv.it+39 0382516223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026