- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07664488
Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing
17. juni 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Andrea Scribante, DDS, PhD
- Telefonnummer: +39 0382516223
- E-mail: andrea.scribante@unipv.it
Studiesteder
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Italy
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Pavia, Italy, Italien, 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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Kontakt:
- Andrea Scribante, DDS, PhD
- Telefonnummer: +39 0382516223
- E-mail: andrea.scribante@unipv.it
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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SNA
Tidsramme: Baseline
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Baseline
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SNB
Tidsramme: Baseline
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Baseline
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ANB
Tidsramme: Baseline
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Baseline
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SN-GoGn
Tidsramme: Baseline
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Baseline
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L1-GoGn
Tidsramme: Baseline
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Baseline
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U1-ANSPNS
Tidsramme: Baseline
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Baseline
|
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Nasolabial angle
Tidsramme: Baseline
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Baseline
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Facial angle
Tidsramme: Baseline
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Baseline
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Wits appraisal
Tidsramme: Baseline
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Baseline
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N-Me
Tidsramme: Baseline
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Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2026
Primær færdiggørelse (Anslået)
30. september 2026
Studieafslutning (Anslået)
30. september 2026
Datoer for studieregistrering
Først indsendt
17. juni 2026
Først indsendt, der opfyldte QC-kriterier
17. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2026-CEPHTRACING
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Data will be available upon motivated request to the corresponding authors.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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