Anxiety, Orthognathic Surgical Procedures, Patient Education, Skeletal Deformities
Conditions
Keywords
Skeletal deformities, Skeletal class II, Skeletal class III, Orthognathic surgery, Patient understanding, Patients' satisfaction, Patient-doctor relationship, Anxiety level, anatomical models, 3D printed models, Patient education
Brief 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
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.
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Single
Intervention model description
This single-blinded randomized controlled trial conducted at King Abdulaziz Dental Hospital to evaluate the impact of three dimensional (3D)-printed anatomical models on patient understanding, anxiety, satisfaction, and communication during the informed consent process for orthognathic surgery. Sixty adult patients scheduled for double- or triple-jaw surgery will be randomly assigned to either a control group (two dimensional (2D) imaging and verbal explanation) or an intervention group (2D imaging plus 3D-printed models). Models were created from CBCT scans using 3D Slicer software and printed with Formlabs resin printers. All consultations are standardized and delivered by calibrated surgeons. Validated Arabic questionnaires will be used to assess outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient understanding | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level | Baseline | 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. |
| Patient-doctor relationship | Baseline | 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). |
| Patient Satisfaction | Baseline | Patient satisfaction scores regarding the consultation and informed consent process, as measured by the validated Arabic version of the Patient Satisfaction Questionnaire (PSQ-18). |
Countries
Saudi Arabia
Contacts
Primary ContactRazan M Baabdullah, BDS,MS,FRCDC
Outcome results
None listed