Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing

NCT07664488 | Recruiting

• 1 other identifier: 2026-CEPHTRACING
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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.

  Baseline

Secondary Outcomes (10)

• SNA

  Baseline

• SNB

  Baseline

• ANB

  Baseline

• SN-GoGn

  Baseline

• L1-GoGn

  Baseline

Study Arms (1)

Orthodontic Patients with Lateral Cephalometric Radiographs

This study includes a single observational arm, since all lateral cephalometric radiographs included in the study will undergo the same analysis procedures. Each radiograph will be evaluated using one digital manual tracing method (Delta-Dent) and three fully automated artificial intelligence-based cephalometric analysis systems (WebCeph™, QuantX, and Smartee). No patient allocation, randomization, or therapeutic intervention will be performed.

Diagnostic Test: Cephalometric Analysis

Interventions

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.

Orthodontic Patients with Lateral Cephalometric Radiographs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy 27100

Pavia, Italy, 27100, Italy

RECRUITING

Central Study Contacts

Andrea Scribante, DDS, PhD

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)