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The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery. The trial also explores how these models affect participants understanding, anxiety, satisfaction, and communication with the surgeon.
The main questions it aims to answer are:
Researchers compares participants who received standard two dimensional (2D) imaging and verbal explanations with those who received the same information plus 3D-printed jaw models.
Participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D Surgical Simulation | Active Comparator | This group received an orthognathic surgery consultation incorporating two-dimensional images generated from virtual surgical planning. These images illustrated the patient's current skeletal deformity and the anticipated surgical movements, providing a visual aid to enhance understanding and facilitate informed decision-making. |
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| 3D Surgical Simulation | Experimental | This group received an orthognathic surgery consultation using 3D-printed anatomical models. The models, representing skeletal Class II and Class III deformities, were customized and modified to simulate osteotomies. During the consultation, these models are used to demonstrate the planned surgical movements, providing patients with a tangible, visual understanding of their condition and the proposed treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-printed Orthognathic Surgical Simulation | Combination Product | Two standardized 3D-printed anatomical models were created-one representing skeletal Class II and the other skeletal Class III. Simulated osteotomies, including Le Fort I and Bilateral Sagittal Split Osteotomies, were performed on the models to demonstrate surgical movements. These models are used to help patients visualize the procedures planned for their specific cases. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient understanding | Patient comprehension scores of their jaw condition, planned surgical procedures (Le Fort I, bilateral sagittal split osteotomy, and genioplasty), potential complications, expected outcomes, and the overall consent process, measured by a structured questionnaire at the time of consent. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | Patient anxiety levels related to orthognathic surgery, as measured by the validated Arabic version of the State-Trait Anxiety Inventory (STAI), a 20-item self-administered questionnaire. | Baseline |
| Patient-doctor relationship |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Razan M Baabdullah, BDS,MS,FRCDC | Contact | +96655501567 | rmsbaabdullah@kau.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Razan M Baabdullah, BDS,MS,FRCDC | King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Razan Baabdullah | Completed | Jeddah | Mecca Region | Saudi Arabia | ||
| King Abdulaziz University Dental Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2025 |
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This single-blinded randomized controlled trial conducted at King Abdulaziz Dental Hospital to evaluate the impact of three dimensional (3D)-printed anatomical models on patient understanding, anxiety, satisfaction, and communication during the informed consent process for orthognathic surgery. Sixty adult patients scheduled for double- or triple-jaw surgery will be randomly assigned to either a control group (two dimensional (2D) imaging and verbal explanation) or an intervention group (2D imaging plus 3D-printed models). Models were created from CBCT scans using 3D Slicer software and printed with Formlabs resin printers. All consultations are standardized and delivered by calibrated surgeons. Validated Arabic questionnaires will be used to assess outcomes.
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Single
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| 2D Visual Representations of Skeletal Movements in Orthognathic Surgery | Combination Product | Two-dimensional images generated from virtual surgical planning-one depicting a Class II skeletal deformity and the other a Class III malocclusion-are used to illustrate the patient's condition and demonstrate the anticipated surgical movements. |
|
Scores for quality of communication and trust between patient and surgeon, as measured by the Arabic version of the Patient-Doctor Relationship Questionnaire (PDRQ-9).
| Baseline |
| Patient Satisfaction | Patient satisfaction scores regarding the consultation and informed consent process, as measured by the validated Arabic version of the Patient Satisfaction Questionnaire (PSQ-18). | Baseline |
| Recruiting |
| Jeddah |
| Saudi Arabia |
|
| Jun 20, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
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