Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdulaziz University
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 18 and above)
Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)
Disqualifiers
Pediatric patients (under 18 years old)
Patients undergoing re-do/revision surgery
Patients with psychiatric disorders
Patients receiving only orthodontic treatment
Trial design
Design model
Parallel
Treatments tested in this trial
3D-printed Orthognathic Surgical Simulation
Combination productTwo 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.
2D Visual Representations of Skeletal Movements in Orthognathic Surgery
Combination productTwo-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: 2D Surgical SimulationActive comparator 1 intervention
Group B: 3D Surgical SimulationExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline2
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).
Time frame
Baseline3
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).
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov