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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Patient Education; Skeletal Deformities; Orthognathic Surgical Procedures
• Intervention / Treatment: Combination product: 2D Visual Representations of Skeletal Movements in Orthognathic Surgery; Combination product: 3D-printed Orthognathic Surgical Simulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Razan M Baabdullah, BDS,MS,FRCDC; Phone Number: +96655501567; Email: rmsbaabdullah@kau.edu.sa

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Recruiting
    • King Abdulaziz University Dental Hospital
    • Contact: Razan Baabdullah, BDS, MS, FRCDC; Phone Number: +966 12 640 0000; Email: rmsbaabdullah@kau.edu.sa
  • Makkah
    • Jeddah, Makkah, Saudi Arabia
      • Completed
      • Razan Baabdullah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.; Other Names: 3d-printed anatomical models

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Razan M Baabdullah, BDS,MS,FRCDC, King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: July 6, 2025
• First Posted (Actual): July 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Patient education; Orthognathic surgery; 3D printed models; Patient understanding; Skeletal deformities; Skeletal class II; Skeletal class III; Patients' satisfaction; Patient-doctor relationship; Anxiety level; anatomical models
• Additional Relevant MeSH Terms: Mental Disorders; Congenital Abnormalities; Anxiety Disorders
• Other Study ID Numbers: 139-11-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No