Skeletal DeformitiesNCT07068412
Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery
A study testing 3D-printed Orthognathic Surgical Simulation and 2D Visual Representations of Skeletal Movements in Orthognathic Surgery in people with Skeletal Deformities and Orthognathic Surgical Procedures, run by King Abdulaziz University at 2 sites in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skeletal Deformities, Orthognathic Surgical Procedures, Anxiety
- What is being tested?
- 3D-printed Orthognathic Surgical Simulation and 2D Visual Representations of Skeletal Movements in Orthognathic Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 1 Jun 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 and above)
- Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 1 recruiting
- Completed
Razan Baabdullah
Jeddah, Mecca Region
- Recruiting
King Abdulaziz University Dental Hospital
Jeddah
Razan Baabdullah, BDS, MS, FRCDC, +966 12 640 0000, rmsbaabdullah@kau.edu.sa
About this study
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
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:
Read more
- 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
- Being tested
- 3D-printed Orthognathic Surgical Simulation, 2D Visual Representations of Skeletal Movements in Orthognathic Surgery
- 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
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed Orthognathic Surgical SimulationCombination product
Also called 3d-printed anatomical models
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.
2D Visual Representations of Skeletal Movements in Orthognathic SurgeryCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| 2D Surgical Simulation | Active comparator | This group received an orthognathic surgery consultation incorporating two-dimensional images generated from virtual surgical planning. These images illustrated the patient's current skeletal deformity and the anticipated surgical movements, providing a visual aid to enhance understanding and facilitate informed decision-making. Receives: Combination Product: 2D Visual Representations of Skeletal Movements in Orthognathic Surgery |
| 3D Surgical Simulation | Experimental | This group received an orthognathic surgery consultation using 3D-printed anatomical models. The models, representing skeletal Class II and Class III deformities, were customized and modified to simulate osteotomies. During the consultation, these models are used to demonstrate the planned surgical movements, providing patients with a tangible, visual understanding of their condition and the proposed treatment. Receives: Combination Product: 3D-printed Orthognathic Surgical Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jun 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razan Baabdullah, King Abdulaziz University
- Investigators
- Razan M Baabdullah, BDS,MS,FRCDC, Principal investigator, King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068412
- Sponsor's protocol ID
- 139-11-24
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07068412
- Acronym / sponsor ID
- 139-11-24
- Keywords
- Skeletal deformities, Skeletal class II, Skeletal class III, Orthognathic surgery, Patient understanding, Patients' satisfaction, Patient-doctor relationship, Anxiety level
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 2D Surgical Simulation | Active comparator | Combination Product: 2D Visual Representations of Skeletal Movements in Orthognathic SurgeryThis group received an orthognathic surgery consultation incorporating two-dimensional images generated from virtual surgical planning. These images illustrated the patient's current skeletal deformity and the anticipated surgical movements, providing a visual aid to enhance understanding and facilitate informed decision-making. |
| 3D Surgical Simulation | Experimental | Combination Product: 3D-printed Orthognathic Surgical SimulationThis group received an orthognathic surgery consultation using 3D-printed anatomical models. The models, representing skeletal Class II and Class III deformities, were customized and modified to simulate osteotomies. During the consultation, these models are used to demonstrate the planned surgical movements, providing patients with a tangible, visual understanding of their condition and the proposed treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged 18 and above)
- Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed Orthognathic Surgical SimulationAlso: 3d-printed anatomical modelsTwo 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 | 3D Surgical Simulation |
| 2D Visual Representations of Skeletal Movements in Orthognathic SurgeryTwo-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. | Combination product | 2D Surgical Simulation |
Primary outcome
Patient understanding
Time frame: 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.
3 secondary outcomes
Anxiety level
Time frame: Baseline
Patient-doctor relationship
Time frame: Baseline
Patient Satisfaction
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Razan M Baabdullah, BDS,MS,FRCDC principal investigator
King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed Orthognathic Surgical Simulation and 2D Visual Representations of Skeletal Movements in Orthognathic Surgery in people with Skeletal Deformities and Orthognathic Surgical Procedures, run by King Abdulaziz University at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Razan M Baabdullah, BDS,MS,FRCDC (+96655501567, rmsbaabdullah@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient understanding (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.