AI-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning

NCT07690774 | Completed

• 2 other identifiers: BHDC-AIORT-2024-01YDA-207
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malocclusion, Angle Class I; Malocclusion, Angle Class II; Malocclusion, Angle Class III

Keywords

Artificial intelligence; Orthodontic diagnosis; Orthodontic treatment planning; Cephalometry; Diagnostic agreement; Clinical decision support; WebCeph; Workflow efficiency; Index of Orthodontic Treatment Need; Premolar extraction decision

Outcome Measures

Primary Outcomes (1)

• Exact Agreement With the Expert Panel for Skeletal Sagittal Classification

  Proportion of participant cases in which the skeletal sagittal classification assigned by each diagnostic workflow exactly agreed with the expert-panel reference classification. Classification was categorized as Class I, Class II, or Class III. Agreement was reported separately for the AI-assisted and conventional workflows using percentage agreement and unweighted Cohen's kappa with 95% confidence intervals. Paired classification accuracy was compared using McNemar's test.

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

Secondary Outcomes (6)

• Agreement With the Expert Panel for IOTN Dental Health Component Grade

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

• Agreement With the Expert Panel for IOTN Aesthetic Component Grade

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

• Diagnostic Accuracy for the Premolar Extraction Decision

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

• Agreement With the Expert Panel for Anchorage-Plan Category

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

• Agreement With the Expert Panel for Primary Appliance Modality

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of new orthodontic patients presenting for assessment at Ben Hafeed Dental Center in Sana'a, Yemen, from March 2024 to March 2026. Eligible participants were aged 12 years or older and had complete, good-quality routine pretreatment orthodontic records. Each enrolled participant contributed one standardized, de-identified case package that was assessed using both the AI-assisted and conventional diagnostic workflows.

You may qualify if:

• 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.

You may not qualify if:

• Cleft lip and/or palate or another craniofacial syndrome that substantially altered the routine orthodontic diagnostic pathway.
• A history of previous comprehensive fixed orthodontic treatment.
• Incomplete, poor-quality, or non-standardized records that prevented comprehensive orthodontic diagnosis and treatment planning.
• Refusal to participate or subsequent withdrawal of consent.

Sponsors & Collaborators

• Ben Hafeed Dental Center: lead

Study Sites (1)

Ben Hafeed Dental Center

Sanaa, Yemen

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I; Malocclusion, Angle Class II; Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Orthodontist

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: March 3, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

YE (1)