Cephalometric AnalysisNCT07664488
Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing
An observational study of Cephalometric Analysis and Cephalometry, run by University of Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cephalometric Analysis, Cephalometry, Artificial Intelligence (AI)
- What is being tested?
- Cephalometric Analysis
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
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
Andrea Scribante, DDS, PhD, +39 0382516223, andrea.scribante@unipv.it
About this study
Official title: Cephalometric Tracing: A Comparison Between Digital Analysis and Artificial Intelligence
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.
Read the 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.
- Conditions
- Cephalometric Analysis, Cephalometry, Artificial Intelligence (AI), Artificial Intelligence (AI) in Diagnosis
- Being tested
- Cephalometric Analysis
- Keywords
- artificial intelligence, cephalometric analysis, lateral cephalogram, landmark identification, automated cephalometric tracing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalometric AnalysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cephalometric Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (10)
SNA
Measured: Baseline
SNB
Measured: Baseline
ANB
Measured: Baseline
SN-GoGn
Measured: Baseline
L1-GoGn
Measured: Baseline
U1-ANSPNS
Measured: Baseline
Nasolabial angle
Measured: Baseline
Facial angle
Measured: Baseline
Wits appraisal
Measured: Baseline
N-Me
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cephalometric AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664488
- Sponsor's protocol ID
- 2026-CEPHTRACING
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.