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

NCT07068412 | Recruiting DMC

• 1 other identifier: 139-11-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

Skeletal deformities; Skeletal class II; Skeletal class III; Orthognathic surgery; Patient understanding; Patients' satisfaction; Patient-doctor relationship; Anxiety level; anatomical models; 3D printed models; Patient education

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Anxiety level

  Baseline

• Patient-doctor relationship

  Baseline

• Patient Satisfaction

  Baseline

Study Arms (2)

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.

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

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.

Combination Product: 3D-printed Orthognathic Surgical Simulation

Interventions

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.

Also known as: 3d-printed anatomical models

3D Surgical Simulation

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.

2D Surgical Simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (2)

Razan Baabdullah

Jeddah, Mecca Region, Saudi Arabia

COMPLETED

King Abdulaziz University Dental Hospital

Jeddah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Razan M Baabdullah, BDS,MS,FRCDC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Razan M Baabdullah, BDS,MS,FRCDC

CONTACT

+96655501567; rmsbaabdullah@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of oral and maxillofacial surgery Affiliation: King Abdulaziz University

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 16, 2025
• Study Start: June 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)