Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D-printed Orthognathic Surgical Simulation, 2D Visual Representations of Skeletal Movements in Orthognathic Surgery.
- Who it may be relevant to
- Registry conditions: Skeletal Deformities, Orthognathic Surgical Procedures, Anxiety, Patient Education. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
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.
Primary outcome measures
- Patient understanding [Time frame: Baseline]
Secondary outcome measures (3)
- Anxiety level [Time frame: Baseline]
- Patient-doctor relationship [Time frame: Baseline]
- Patient Satisfaction [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Saudi Arabia · 2 centers
- Razan Baabdullah — Jeddah
- King Abdulaziz University Dental Hospital — Jeddah
Identifiers
NCT: NCT07068412 · 139-11-24