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临床试验/NCT07246018
NCT07246018已完成不适用

The Accuracy and Reliability of Orthodontic Cephalometry Analysis Using Web-Based Artificial Intelligence Program

International Islamic University Malaysia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Mean differences between manual and AI-based measurements at T₁

研究概览

简要总结

This study compares the accuracy and reliability of artificial intelligence (AI) software for analyzing dental X-rays to the traditional manual tracing method used by dentists.

Lateral cephalometric radiographs are special X-rays of the head used in orthodontics (teeth straightening) to measure jawbone positions, tooth angles, and facial proportions. Traditionally, orthodontists manually trace these X-rays using pencil and paper to identify key landmarks and make measurements. This manual method is time-consuming and can vary between different practitioners or even when the same practitioner measures twice.

AI-based software can automatically identify these landmarks and perform measurements instantly. This study examined 40 dental X-rays to determine if the AI software (WeDoCeph) is as accurate and more reliable than manual tracing.

Each X-ray was measured twice - once manually by a trained examiner and once by AI software - at two different times (4 weeks apart). The researchers compared 15 different measurements, including 8 angles and 7 distances, to assess accuracy and reliability.

详细描述

Lateral cephalometric analysis is essential for orthodontic diagnosis and treatment planning. The traditional manual tracing method involves identifying anatomical landmarks on radiographs using pencil, ruler, and protractor, which is subjective, time-consuming, and prone to intra- and inter-observer variability.

This diagnostic accuracy study evaluated the WeDoCeph AI-based cephalometric analysis software against conventional manual tracing. The study used a comparative repeated-measures design where each radiograph was analysed by both methods at two time points (T₀ and T₁, separated by 4 weeks) to assess both accuracy and reliability.

Sample size calculation was based on 95% power and a 0.05 significance level, resulting in 40 lateral cephalometric radiographs. All measurements included angular parameters (SNA, SNB, ANB, FMPA, MMPA, UIA, LIA, IIA) and linear parameters (A-N perpendicular, POG-N perpendicular, ANS-Me, SN, UFH, MxPI, MnPI).

Paired T-Test will be employed as the statistical analysis method for comparisons and Intraclass Correlation Coefficient (ICC) for reliability assessment. The study aimed to determine whether AI-based cephalometric analysis provides sufficient accuracy and superior reliability for clinical application in orthodontic practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Pretreatment/post-treatment lateral cephalometric radiographs
  • High-quality cephalograms with visible anatomical landmarks

排除标准

  • Patients with surgical rigid fixations, orthodontic appliances and dental prostheses visible on radiographs
  • Very poor quality/diagnostically unacceptable radiographs
  • Patients with syndromes or with craniofacial deformities

结局指标

主要结局

Mean differences between manual and AI-based measurements at T₁

时间窗: 4 weeks

Paired T-Test comparison of all 15 measurements between manual tracing and AI analysis at 4-week time point

Intraclass Correlation Coefficient (ICC) for repeated manual measurements

时间窗: Baseline (T₀) and 4 weeks later (T₁)

ICC calculated for all 15 cephalometric measurements (8 angular and 7 linear) performed manually at two time points to assess intra-examiner reliability

Intraclass Correlation Coefficient (ICC) for repeated AI measurements

时间窗: Baseline (T₀) and 4 weeks later (T₁)

ICC calculated for all 15 cephalometric measurements performed by WeDoCeph software at two time points to assess consistency

Mean differences between manual and AI-based measurements at T₀

时间窗: Baseline (T₀)

Paired T-Test comparison of all 15 measurements between manual tracing and AI analysis at initial time point

次要结局

  • Angular Measurements(Baseline (T₀) and 4 weeks (T₁))
  • Linear Measurements(Baseline (T₀) and 4 weeks (T₁))
  • Inter-examiner Reliability(During calibration phase)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siti Hajjar Nasir

Assistant Professor Dr.

International Islamic University Malaysia

研究点 (1)

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