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Completed
NCT07690774
AI-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning
Conditions: Malocclusion, Angle Class I, Malocclusion, Angle Class II, Malocclusion, Angle Class III
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Enrollment: 120
Sponsor: Ben Hafeed Dental Center
Location: Ben Hafeed Dental Center Sanaa
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.
Eligibility Criteria
Inclusion Criteria:
1. New orthodontic patients aged 12 years or older.
2. 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.
3. Pretreatment records of sufficient quality to permit comprehensive orthodontic diagnosis and treatment planning.
4. 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:
1. Cleft lip and/or palate or another craniofacial syndrome that substantially altered the routine orthodontic diagnostic pathway.
2. A history of previous comprehensive fixed orthodontic treatment.
3. Incomplete, poor-quality, or non-standardized records that prevented comprehensive orthodontic diagnosis and treatment planning.
4. Refusal to participate or subsequent withdrawal of consent.
Source: ClinicalTrials.gov (NCT07690774). StuddyBuddy aggregates publicly available trial information.