Accuracy and Reliability of Artificial Intelligence Cephalometric Analysis Software Compared to Manual Tracing

International Islamic University Malaysia

Status: Completed

Conditions: Cephalometric Analysis; Orthodontic; Cephalometry

Treatments: Diagnostic Test: AI-Based Cephalometric Analysis (WeDoCeph Software); Diagnostic Test: Manual Cephalometric Tracing

Study type: Observational

Funder types: Other

Identifiers

NCT07246018

IREC 2023-045

CHAIN 22-001-0001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

40 participants in 1 patient group

Orthodontic Patients with Lateral Cephalometric Radiographs

Description:

Lateral cephalometric radiographs from 40 orthodontic patients collected between January 2023 and June 2023 from the Orthodontic Specialist Clinic. Each radiograph was analyzed using both manual tracing and AI-based software (WeDoCeph) at two time points (initial and 4 weeks later)

Treatment:

Diagnostic Test: Manual Cephalometric Tracing

Diagnostic Test: AI-Based Cephalometric Analysis (WeDoCeph Software)