CompletedNot Applicable

AI-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning

Yemen120 participantsStarted 2024-03-03

Plain-language summary

This study compared an artificial intelligence-assisted orthodontic diagnostic workflow using WebCeph with a conventional clinician-based workflow. The study included 120 new orthodontic patients treated at Ben Hafeed Dental Center in Sana'a, Yemen, between March 2024 and March 2026. For each participant, the researchers prepared a de-identified package of routine pretreatment records, including clinical findings, extraoral and intraoral photographs, panoramic and lateral cephalometric radiographs, and dental models or digital scans. The same case package was independently assessed using both the artificial intelligence-assisted and conventional workflows. An independent panel of five expert orthodontists reviewed the cases and established the reference standard. The main outcome was agreement with the expert panel for skeletal sagittal classification as Class I, Class II, or Class III. Other outcomes included orthodontic treatment-need grades, premolar extraction decisions, anchorage planning, appliance selection, and the time required to complete each diagnostic workflow. Participation did not alter the routine orthodontic care provided to patients, and final clinical decisions remained the responsibility of the treating orthodontist.

Who can participate

Age range

12 Years

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

. New orthodontic patients aged 12 years or older.
. Availability of complete routine pretreatment records, including clinical examination data, standardized extraoral and intraoral photographs, panoramic and lateral cephalometric radiographs, and dental models or digital scans.
. Pretreatment records of sufficient quality to permit comprehensive orthodontic diagnosis and treatment planning.
. Provision of written informed consent by adult participants or written parental or legal-guardian permission, together with participant assent for minors, in accordance with applicable local requirements.

Exclusion criteria

. Cleft lip and/or palate or another craniofacial syndrome that substantially altered the routine orthodontic diagnostic pathway.

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

Exact Agreement With the Expert Panel for Skeletal Sagittal Classification

Timeframe: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.

Trial details

NCT IDNCT07690774

SponsorBen Hafeed Dental Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Malocclusion, Angle Class I trials