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

NCT07068412 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Principal Investigators

  • Razan M Baabdullah, BDS,MS,FRCDC · King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-08-30
Completion
2025-08-30

Countries

  • Saudi Arabia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068412 on ClinicalTrials.gov