NCT07068412

Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery

Impact of 3D-Printed Anatomical Models on Patient Understanding, Anxiety, Patient-Doctor Relationship, and Overall Satisfaction During the Informed Consent Process in Orthognathic Surgery: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * Do 3D-printed anatomical models improve participants understanding of their jaw condition and the surgical procedure? * Do they reduce participants anxiety before surgery? * Do they enhance overall participants satisfaction and the physician-patient relationship? 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: * Scheduled for double- or triple-jaw orthognathic surgery * Randomly assigned to receive either traditional 2D education or the 3D-printed model intervention * Complete a validated questionnaires assessing understanding, anxiety, satisfaction, and doctor-patient communication

Conditions

• Skeletal Deformities
• Orthognathic Surgical Procedures
• Anxiety
• Patient Education

Interventions

Type	Name	Description
COMBINATION_PRODUCT	3D-printed Orthognathic Surgical Simulation	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.
COMBINATION_PRODUCT	2D Visual Representations of Skeletal Movements in Orthognathic Surgery	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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

2 sites across 1 country: Saudi Arabia