- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07664488
Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing
17. juni 2026 oppdatert av: Andrea Scribante, University of Pavia
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Andrea Scribante, DDS, PhD
- Telefonnummer: +39 0382516223
- E-post: andrea.scribante@unipv.it
Studiesteder
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Italy
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Pavia, Italy, Italia, 27100
- Rekruttering
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy 27100
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Ta kontakt med:
- Andrea Scribante, DDS, PhD
- Telefonnummer: +39 0382516223
- E-post: andrea.scribante@unipv.it
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement between AI-based cephalometric analysis and digital manual tracing
Tidsramme: Baseline
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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.
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Baseline
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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SNA
Tidsramme: Baseline
|
Baseline
|
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SNB
Tidsramme: Baseline
|
Baseline
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ANB
Tidsramme: Baseline
|
Baseline
|
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SN-GoGn
Tidsramme: Baseline
|
Baseline
|
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L1-GoGn
Tidsramme: Baseline
|
Baseline
|
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U1-ANSPNS
Tidsramme: Baseline
|
Baseline
|
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Nasolabial angle
Tidsramme: Baseline
|
Baseline
|
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Facial angle
Tidsramme: Baseline
|
Baseline
|
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Wits appraisal
Tidsramme: Baseline
|
Baseline
|
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N-Me
Tidsramme: Baseline
|
Baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
30. september 2026
Studiet fullført (Antatt)
30. september 2026
Datoer for studieregistrering
Først innsendt
17. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2026-CEPHTRACING
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Data will be available upon motivated request to the corresponding authors.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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