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AI-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning

Artificial Intelligence-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning: A Prospective Paired Diagnostic-Agreement Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07690774
Acronym
AI-OrthoDx
Enrollment
120
Registered
2026-07-08
Start date
2024-03-03
Completion date
2026-03-31
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

This was a prospective paired diagnostic-agreement study conducted at Ben Hafeed Dental Center, Sana'a, Yemen, from March 2024 to March 2026. A total of 120 eligible new orthodontic patients were included. Each participant contributed one standardized, de-identified pretreatment case package. Every case was evaluated using both an artificial intelligence-assisted workflow and a conventional clinician-based workflow, allowing direct within-case comparison. The artificial intelligence-assisted workflow used WebCeph Premium, software version 2.0.3 (AssembleCircle Corp., Seongnam-si, Republic of Korea). The lateral cephalometric radiograph was uploaded to the software for automated anatomical landmark identification and generation of angular and linear cephalometric measurements. The original automated landmarks and measurements were recorded without manual correction. The reviewer interpreted the automated findings together with the remaining standardized pretreatment records and entered the required diagnostic and treatment-planning decisions. For the conventional workflow, two calibrated orthodontists independently reviewed each case using routine clinical, photographic, radiographic, cephalometric, and dental-model assessment. Conventional cephalometric evaluation was performed using manual landmark identification through a local Dolphin Imaging-based workflow. When the two conventional orthodontists disagreed on an endpoint, a third calibrated orthodontist adjudicated the disputed decision. The reference standard was established by an independent panel of five experienced orthodontists. Each expert independently reviewed the de-identified cases while blinded to the artificial intelligence-assisted and conventional workflow results. Reference decisions were established through majority agreement, with additional review and structured adjudication when required. The primary endpoint was skeletal sagittal classification, categorized as Class I, Class II, or Class III. Secondary endpoints included the Index of Orthodontic Treatment Need Dental Health Component, the Index of Orthodontic Treatment Need Aesthetic Component, premolar extraction decision, anchorage-plan category, and primary appliance modality. Workflow duration was measured from the beginning of case assessment until all required decisions had been entered. The study included 71 females and 49 males. The mean participant age was 20.3 years, with a standard deviation of 3.9 years and a range of 14 to 33 years. The protocol was approved by the Yemen Dental Association under approval number 207. Written informed consent was obtained from adult participants. For minors, written parental or legal-guardian permission and participant assent were obtained.

Interventions

None listed

Sponsors

Ben Hafeed Dental Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Exact Agreement With the Expert Panel for Skeletal Sagittal ClassificationAt baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.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.

Secondary

MeasureTime frameDescription
Agreement With the Expert Panel for IOTN Dental Health Component GradeAt baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.Agreement between each workflow and the expert-panel reference grade for the Index of Orthodontic Treatment Need Dental Health Component, graded from 1 to 5. Outcomes included exact agreement, agreement within one grade, weighted Cohen's kappa with 95% confidence intervals, and absolute grade deviation.
Agreement With the Expert Panel for IOTN Aesthetic Component GradeAt baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.Agreement between each workflow and the expert-panel reference grade for the Index of Orthodontic Treatment Need Aesthetic Component, graded from 1 to 10. Outcomes included exact agreement, agreement within one grade, weighted Cohen's kappa with 95% confidence intervals, and absolute grade deviation.
Diagnostic Accuracy for the Premolar Extraction DecisionAt baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.Accuracy of each workflow in classifying whether premolar extraction was indicated, using the expert-panel decision as the reference standard. Outcomes included sensitivity, specificity, positive predictive value, negative predictive value, overall accuracy, and unweighted Cohen's kappa with 95% confidence intervals.
Agreement With the Expert Panel for Anchorage-Plan CategoryAt baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.Proportion of participant cases in which the anchorage-plan category assigned by each workflow agreed with the expert-panel reference decision. Categories were conventional anchorage, reinforced anchorage, or skeletal anchorage. Agreement was evaluated using percentage agreement and unweighted Cohen's kappa.
Agreement With the Expert Panel for Primary Appliance ModalityAt baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.Proportion of participant cases in which the primary appliance modality selected by each workflow agreed with the expert-panel reference decision. Categories were fixed appliance, clear aligner, or functional appliance. Agreement was evaluated using percentage agreement and unweighted Cohen's kappa.
Time Required to Complete the Diagnostic and Treatment-Planning WorkflowDuring the baseline diagnostic assessment; measured continuously from case opening to completion, within 1 day.Total time in minutes from opening the standardized case package until all required diagnostic and treatment-planning decisions were entered. For the conventional workflow, the mean of the two initial orthodontists' assessment times was used. Third-rater adjudication time was excluded. The within-case paired difference between workflows was calculated.

Countries

Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026