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

King Abdulaziz University

Status: Enrolling

Conditions: Skeletal Deformities; Orthognathic Surgical Procedures; Patient Education; Anxiety

Treatments: Combination Product: 2D Visual Representations of Skeletal Movements in Orthognathic Surgery; Combination Product: 3D-printed Orthognathic Surgical Simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07068412

139-11-24

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (aged 18 and above)
• Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)

Exclusion criteria

• Pediatric patients (under 18 years old)
• Patients undergoing re-do/revision surgery
• Patients with psychiatric disorders
• Patients receiving only orthodontic treatment
• Patients undergoing single-jaw surgery

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

2D Surgical Simulation

Active Comparator group

Description:

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.

Treatment:

Combination Product: 2D Visual Representations of Skeletal Movements in Orthognathic Surgery

3D Surgical Simulation

Experimental group

Description:

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.

Treatment:

Combination Product: 3D-printed Orthognathic Surgical Simulation