RecruitingNot ApplicableNCT07068412

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


Sponsor

King Abdulaziz University

Enrollment

60 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether showing patients a physical 3D-printed model of their own jaw and facial bones — created from their CT scan data — before jaw-realignment surgery (orthognathic surgery) helps them better understand the procedure, feel less anxious, and make more informed decisions compared to patients who only receive standard explanations. **You may be eligible if...** - You are 18 or older - You are scheduled for a double-jaw (bimaxillary) or triple-jaw orthognathic (jaw-realignment) surgery **You may NOT be eligible if...** - You are under 18 years old - You are having revision (redo) surgery on a jaw that was previously operated on - You have a diagnosed psychiatric disorder - You are receiving only orthodontic treatment (braces) without surgery - You are only having single-jaw surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCT3D-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_PRODUCT2D 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.


Locations(2)

Razan Baabdullah

Jeddah, Mecca Region, Saudi Arabia

King Abdulaziz University Dental Hospital

Jeddah, Saudi Arabia

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NCT07068412


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