Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing (NCT07664488) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing
Italy100 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement between AI-based cephalometric analysis and digital manual tracing