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

NCT ID: NCT07068412

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

2D Surgical Simulation

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.

Group Type: ACTIVE_COMPARATOR

2D Visual Representations of Skeletal Movements in Orthognathic Surgery

Intervention Type: 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.

3D Surgical Simulation

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.

Group Type: EXPERIMENTAL

3D-printed Orthognathic Surgical Simulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

3d-printed anatomical models

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Razan Baabdullah

Assistant professor of oral and maxillofacial surgery Affiliation: King Abdulaziz University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Razan M Baabdullah, BDS,MS,FRCDC

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Locations

Razan Baabdullah

Jeddah, Mecca Region, Saudi Arabia

Site Status: COMPLETED

King Abdulaziz University Dental Hospital

Jeddah, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Razan M Baabdullah, BDS,MS,FRCDC

Role: CONTACT

rmsbaabdullah@kau.edu.sa

+96655501567

Facility Contacts

Razan Baabdullah, BDS, MS, FRCDC

Role: primary

rmsbaabdullah@kau.edu.sa

+966 12 640 0000

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

139-11-24

Identifier Type: -

Identifier Source: org_study_id