Artificial Intelligence-Assisted Versus Conventional Orthodontic Diagnosis and Treatment Planning: A Prospective Paired Diagnostic-Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Exact Agreement With the Expert Panel for Skeletal Sagittal Classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Exact Agreement With the Expert Panel for Skeletal Sagittal Classification
时间窗: 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.
次要结局
- 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.)
- Time Required to Complete the Diagnostic and Treatment-Planning Workflow(During the baseline diagnostic assessment; measured continuously from case opening to completion, within 1 day.)
研究者
Dr. Salah Mohammed Salem Ben Hafedh
Principal Investigator and Orthodontist
Ben Hafeed Dental Center