CephalometryNCT07246018
Accuracy and Reliability of Artificial Intelligence Cephalometric Analysis Software Compared to Manual Tracing
An observational study of Cephalometry and Orthodontic, run by International Islamic University Malaysia at 1 site in Malaysia.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cephalometry, Orthodontic, Cephalometric Analysis
- What is being tested?
- Manual Cephalometric Tracing and AI-Based Cephalometric Analysis (WeDoCeph Software)
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Jan 2023to 30 Jun 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consisted of radiographs from orthodontic patients at various stages of treatment, including both pretreatment (initial diagnostic) and post-treatment radiographs. All radiographs were high-quality digital or digitized lateral cephalograms suitable for landmark identification and measurement. Patients with surgical rigid fixations, orthodontic appliances visible on radiographs, or dental prostheses were excluded to ensure clear visualization of anatomical landmarks. Additionally, radiographs of very poor quality or from patients with diagnosed syndromes or craniofacial deformities were excluded to maintain consistency in anatomical structure assessment. The unit of analysis is the cephalometric radiograph rather than individual patients, as each radiograph represents a single diagnostic assessment.
Who may be able to join
- Pretreatment/post-treatment lateral cephalometric radiographs
- High-quality cephalograms with visible anatomical landmarks
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Malaysia1 site
Orthodontic Specialist Clinic, Kulliyyah of Dentistry
Kuantan, Pahang, 25200
About this study
Official title: The Accuracy and Reliability of Orthodontic Cephalometry Analysis Using Web-Based Artificial Intelligence Program
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.
Read more
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.
Read the detailed 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.
- Conditions
- Cephalometry, Orthodontic, Cephalometric Analysis
- Being tested
- Manual Cephalometric Tracing, AI-Based Cephalometric Analysis (WeDoCeph Software)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Cephalometric TracingDiagnostic test
Conventional manual cephalometric analysis performed by trained examiner using traditional tracing technique. Lateral cephalometric radiographs are hand-traced in a darkened room using a view box for transillumination. A 25cm x 18cm radiographic film is used as the base, with a 21cm x 16cm matte acetate tracing paper taped over it. Hard and soft tissue cephalometric landmarks are manually identified and traced using a 0.3mm 2HB pencil. Angular measurements are obtained using a protractor, and linear measurements using a ruler. All 15 cephalometric measurements (8 angular: SNA, SNB, ANB, FMPA, MMPA, UIA, LIA, IIA; and 7 linear: A-N perpendicular, POG-N perpendicular, ANS-Me, SN, UFH, MxPI, MnPI) are calculated manually. Each radiograph is traced and analyzed twice at 4-week intervals by the same examiner to assess intra-examiner reliability.
AI-Based Cephalometric Analysis (WeDoCeph Software)Diagnostic test
Automated cephalometric analysis using WeDoCeph artificial intelligence-based software. Digital lateral cephalometric radiographs are imported as high-quality JPEG images into the software platform. The AI system automatically identifies and traces cephalometric landmarks using deep learning algorithms, then instantly generates all measurements based on the predefined parameters. The same 15 cephalometric measurements obtained in manual tracing (8 angular: SNA, SNB, ANB, FMPA, MMPA, UIA, LIA, IIA; and 7 linear: A-N perpendicular, POG-N perpendicular, ANS-Me, SN, UFH, MxPI, MnPI) are automatically calculated by the software. Each radiograph is analyzed twice at 4-week intervals using the previously uploaded digital images to assess reproducibility and consistency of the AI system. No manual landmark identification or measurement calculation is required.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic Patients with Lateral Cephalometric Radiographs | 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) Receives: Diagnostic Test: Manual Cephalometric Tracing; Diagnostic Test: AI-Based Cephalometric Analysis (WeDoCeph Software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass Correlation Coefficient (ICC) for repeated manual measurements
ICC calculated for all 15 cephalometric measurements (8 angular and 7 linear) performed manually at two time points to assess intra-examiner reliability
Measured: Baseline (T₀) and 4 weeks later (T₁)
Intraclass Correlation Coefficient (ICC) for repeated AI measurements
ICC calculated for all 15 cephalometric measurements performed by WeDoCeph software at two time points to assess consistency
Measured: Baseline (T₀) and 4 weeks later (T₁)
Mean differences between manual and AI-based measurements at T₀
Paired T-Test comparison of all 15 measurements between manual tracing and AI analysis at initial time point
Measured: Baseline (T₀)
Mean differences between manual and AI-based measurements at T₁
Paired T-Test comparison of all 15 measurements between manual tracing and AI analysis at 4-week time point
Measured: 4 weeks
Secondary outcomes (3)
Angular Measurements
Comparison of angular cephalometric measurements between methods
Measured: Baseline (T₀) and 4 weeks (T₁)
Linear Measurements
Comparison of linear cephalometric measurements between methods
Measured: Baseline (T₀) and 4 weeks (T₁)
Inter-examiner Reliability
10% of radiographs were analyzed by three examiners to ensure inter-examiner agreement
Measured: During calibration phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start2 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CephalometryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Hajjar Nasir, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246018
- Sponsor's protocol ID
- IREC 2023-045
- Other IDs
- CHAIN 22-001-0001
- Status last verified
- Jan 2023
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect patient privacy and confidentiality. The study involves radiographic images and associated measurements from orthodontic patients. Even with de-identification, radiographic images may be potentially identifiable. Data sharing was not included in the original ethics approval and informed consent process. Aggregate summary data and statistical results are available in the published manuscript.
Publications
Alqahtani H. Evaluation of an online website-based platform for cephalometric analysis. J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):53-57. doi: 10.1016/j.jormas.2019.04.017. Epub 2019 May 3.
PubMed 31059836Kazimierczak W, Gawin G, Janiszewska-Olszowska J, Dyszkiewicz-Konwinska M, Nowicki P, Kazimierczak N, Serafin Z, Orhan K. Comparison of Three Commercially Available, AI-Driven Cephalometric Analysis Tools in Orthodontics. J Clin Med. 2024 Jun 26;13(13):3733. doi: 10.3390/jcm13133733.
PubMed 38999299Lee JH, Yu HJ, Kim MJ, Kim JW, Choi J. Automated cephalometric landmark detection with confidence regions using Bayesian convolutional neural networks. BMC Oral Health. 2020 Oct 7;20(1):270. doi: 10.1186/s12903-020-01256-7.
PubMed 33028287
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy and Reliability of Orthodontic Cephalometry Analysis Using Web-Based Artificial Intelligence Program
- ClinicalTrials.gov ID
- NCT07246018
- Acronym / sponsor ID
- IREC 2023-045
- Conditions
- Cephalometry, Orthodontic, Cephalometric Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthodontic Patients with Lateral Cephalometric Radiographs | – | Diagnostic Test: Manual Cephalometric Tracing, Diagnostic Test: AI-Based Cephalometric Analysis (WeDoCeph Software)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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of radiographs from orthodontic patients at various stages of treatment, including both pretreatment (initial diagnostic) and post-treatment radiographs. All radiographs were high-quality digital or digitized lateral cephalograms suitable for landmark identification and measurement. Patients with surgical rigid fixations, orthodontic appliances visible on radiographs, or dental prostheses were excluded to ensure clear visualization of anatomical landmarks. Additionally, radiographs of very poor quality or from patients with diagnosed syndromes or craniofacial deformities were excluded to maintain consistency in anatomical structure assessment. The unit of analysis is the cephalometric radiograph rather than individual patients, as each radiograph represents a single diagnostic assessment.
Key inclusion criteria (2 listed)
- Pretreatment/post-treatment lateral cephalometric radiographs
- High-quality cephalograms with visible anatomical landmarks
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Cephalometric TracingConventional manual cephalometric analysis performed by trained examiner using traditional tracing technique. Lateral cephalometric radiographs are hand-traced in a darkened room using a view box for transillumination. A 25cm x 18cm radiographic film is used as the base, with a 21cm x 16cm matte acetate tracing paper taped over it. Hard and soft tissue cephalometric landmarks are manually identified and traced using a 0.3mm 2HB pencil. Angular measurements are obtained using a protractor, and linear measurements using a ruler. All 15 cephalometric measurements (8 angular: SNA, SNB, ANB, FMPA, MMPA, UIA, LIA, IIA; and 7 linear: A-N perpendicular, POG-N perpendicular, ANS-Me, SN, UFH, MxPI, MnPI) are calculated manually. Each radiograph is traced and analyzed twice at 4-week intervals by the same examiner to assess intra-examiner reliability. | Diagnostic test | Orthodontic Patients with Lateral Cephalometric Radiographs |
| AI-Based Cephalometric Analysis (WeDoCeph Software)Automated cephalometric analysis using WeDoCeph artificial intelligence-based software. Digital lateral cephalometric radiographs are imported as high-quality JPEG images into the software platform. The AI system automatically identifies and traces cephalometric landmarks using deep learning algorithms, then instantly generates all measurements based on the predefined parameters. The same 15 cephalometric measurements obtained in manual tracing (8 angular: SNA, SNB, ANB, FMPA, MMPA, UIA, LIA, IIA; and 7 linear: A-N perpendicular, POG-N perpendicular, ANS-Me, SN, UFH, MxPI, MnPI) are automatically calculated by the software. Each radiograph is analyzed twice at 4-week intervals using the previously uploaded digital images to assess reproducibility and consistency of the AI system. No manual landmark identification or measurement calculation is required. | Diagnostic test | Orthodontic Patients with Lateral Cephalometric Radiographs |
Primary outcome
Intraclass Correlation Coefficient (ICC) for repeated manual measurements
Time frame: 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
Time frame: 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
Time frame: Baseline (T₀)
Paired T-Test comparison of all 15 measurements between manual tracing and AI analysis at initial time point
Mean differences between manual and AI-based measurements at T₁
Time frame: 4 weeks
Paired T-Test comparison of all 15 measurements between manual tracing and AI analysis at 4-week time point
3 secondary outcomes
Angular Measurements
Time frame: Baseline (T₀) and 4 weeks (T₁)
Linear Measurements
Time frame: Baseline (T₀) and 4 weeks (T₁)
Inter-examiner Reliability
Time frame: During calibration phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 31059836Alqahtani H. Evaluation of an online website-based platform for cephalometric analysis. J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):53-57. doi: 10.1016/j.jormas.2019.04.017. Epub 2019 May 3.
- Results publication: PubMed 38999299Kazimierczak W, Gawin G, Janiszewska-Olszowska J, Dyszkiewicz-Konwinska M, Nowicki P, Kazimierczak N, Serafin Z, Orhan K. Comparison of Three Commercially Available, AI-Driven Cephalometric Analysis Tools in Orthodontics. J Clin Med. 2024 Jun 26;13(13):3733. doi: 10.3390/jcm13133733.
- Results publication: PubMed 33028287Lee JH, Yu HJ, Kim MJ, Kim JW, Choi J. Automated cephalometric landmark detection with confidence regions using Bayesian convolutional neural networks. BMC Oral Health. 2020 Oct 7;20(1):270. doi: 10.1186/s12903-020-01256-7.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect patient privacy and confidentiality. The study involves radiographic images and associated measurements from orthodontic patients. Even with de-identification, radiographic images may be potentially identifiable. Data sharing was not included in the original ethics approval and informed consent process. Aggregate summary data and statistical results are available in the published manuscript.
Related trials for Cephalometry
RecruitingObservational study
Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing
Cephalometric Analysis, Cephalometry
Active, not recruitingObservational study
Correlation Between Stages of Mandibular 2nd Molar Calcification and CVMI for Assessment of Skeletal Maturation: A Cross Sectional Study
Correlation Between Second Molar Calcification Stage and CVMI for Skeletal Maturation Assessment in Egyptian Population
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cephalometry and Orthodontic, run by International Islamic University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass Correlation Coefficient (ICC) for repeated manual measurements (time frame: Baseline (T₀) and 4 weeks later (T₁)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246018, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.