Malocclusion, Angle Class IAI-OrthoDxNCT07690774
AI-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning
An observational study of Malocclusion, Angle Class I and Malocclusion, Angle Class II, run by Ben Hafeed Dental Center at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Malocclusion, Angle Class I, Malocclusion, Angle Class II, Malocclusion, Angle Class III
- How many people
- 120 participants
- Where
- 1 siteYemen
- Study dates
- 3 Mar 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Malocclusion, Angle Class I, Malocclusion, Angle Class II, Malocclusion, Angle Class III
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for IOTN Aesthetic Component Grade
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.
Measured: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Diagnostic Accuracy for the Premolar Extraction Decision
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.
Measured: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for Anchorage-Plan Category
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.
Measured: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for Primary Appliance Modality
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.
Measured: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Time Required to Complete the Diagnostic and Treatment-Planning Workflow
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.
Measured: During the baseline diagnostic assessment; measured continuously from case opening to completion, within 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start3 Mar 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben Hafeed Dental Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Salah Mohammed Salem Ben Hafedh, Ben Hafeed Dental Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690774
- Sponsor's protocol ID
- BHDC-AIORT-2024-01
- Other IDs
- YDA-207
- Acronym
- AI-OrthoDx
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning: A Prospective Paired Diagnostic-Agreement Study
- ClinicalTrials.gov ID
- NCT07690774
- Acronym / sponsor ID
- AI-OrthoDx / BHDC-AIORT-2024-01
- Keywords
- Artificial intelligence, Orthodontic diagnosis, Orthodontic treatment planning, Cephalometry, Diagnostic agreement, Clinical decision support, WebCeph, Workflow efficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ben Hafeed Dental CenterUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exact Agreement With the Expert Panel for Skeletal Sagittal Classification
Time frame: 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.
6 secondary outcomes
Agreement With the Expert Panel for IOTN Dental Health Component Grade
Time frame: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for IOTN Aesthetic Component Grade
Time frame: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Diagnostic Accuracy for the Premolar Extraction Decision
Time frame: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for Anchorage-Plan Category
Time frame: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Agreement With the Expert Panel for Primary Appliance Modality
Time frame: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.
Time Required to Complete the Diagnostic and Treatment-Planning Workflow
Time frame: During the baseline diagnostic assessment; measured continuously from case opening to completion, within 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, Angle Class I and Malocclusion, Angle Class II, run by Ben Hafeed Dental Center at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exact Agreement With the Expert Panel for Skeletal Sagittal Classification (time frame: At baseline pretreatment assessment; one case evaluation per workflow, completed within 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.