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Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing

2026年6月17日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Italy
      • Pavia、Italy、意大利、27100
        • 招聘中
        • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy 27100
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Agreement between AI-based cephalometric analysis and digital manual tracing
大体时间:Baseline
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

次要结果测量

结果测量
大体时间
SNA
大体时间:Baseline
Baseline
SNB
大体时间:Baseline
Baseline
ANB
大体时间:Baseline
Baseline
SN-GoGn
大体时间:Baseline
Baseline
L1-GoGn
大体时间:Baseline
Baseline
U1-ANSPNS
大体时间:Baseline
Baseline
Nasolabial angle
大体时间:Baseline
Baseline
Facial angle
大体时间:Baseline
Baseline
Wits appraisal
大体时间:Baseline
Baseline
N-Me
大体时间:Baseline
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Data will be available upon motivated request to the corresponding authors.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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