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AI-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning (AI-OrthoDx)

2 juli 2026 bijgewerkt door: Dr. Salah Mohammed Salem Ben Hafedh, Ben Hafeed Dental Center

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Jemen
      • Sanaa, Jemen
        • Ben Hafeed Dental Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exact Agreement With the Expert Panel for Skeletal Sagittal Classification
Tijdsspanne: At 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.
At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Agreement With the Expert Panel for IOTN Dental Health Component Grade
Tijdsspanne: At 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.
At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for IOTN Aesthetic Component Grade
Tijdsspanne: At 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.
At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Diagnostic Accuracy for the Premolar Extraction Decision
Tijdsspanne: At 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.
At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for Anchorage-Plan Category
Tijdsspanne: At 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.
At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for Primary Appliance Modality
Tijdsspanne: At 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.
At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Time Required to Complete the Diagnostic and Treatment-Planning Workflow
Tijdsspanne: During 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.
During the baseline diagnostic assessment; measured continuously from case opening to completion, within 1 day.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ben Hafeed Dental Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 maart 2024

Primaire voltooiing (Werkelijk)

31 maart 2026

Studie voltooiing (Werkelijk)

31 maart 2026

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

8 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BHDC-AIORT-2024-01
  • YDA-207 (Andere identificatie: Yemen Dental Association)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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