Using a 3D-printed jaw model to improve understanding before orthognathic surgery
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
Run by King Abdulaziz University · NCT07068412 · Data updated 2026-11-12
This test will see if giving adults scheduled for double- or triple-jaw surgery a 3D-printed model of their jaw helps them understand the procedure better, lowers preoperative anxiety, and increases satisfaction compared with standard 2D explanations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | King Abdulaziz University Academic / other |
| Locations | 2 sites (Jeddah, Mecca Region and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | August 30, 2025 |
| Study ends | August 30, 2025 |
| Registry record updated | July 16, 2025 |
| Trial ID | NCT07068412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are scheduled for primary double- or triple-jaw orthognathic surgery and do not have psychiatric disorders or planned revision procedures are ideal candidates.
✕Probably not a fit
Patients under 18, those undergoing single-jaw or revision surgeries, patients with psychiatric disorders, and those receiving only orthodontic treatment are not likely to be eligible or to benefit from this specific intervention in the trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a randomized comparison at King Abdulaziz University Dental Hospital, adults scheduled for primary double- or triple-jaw orthognathic surgery are assigned to receive either standard 2D imaging with verbal explanation or the same information plus a patient-specific 3D-printed anatomical model. The trial measures patient understanding of their jaw condition and planned surgical movements, preoperative anxiety, satisfaction, and perceived communication with the surgeon. Patients with psychiatric disorders, revision surgeries, single-jaw procedures, or those under 18 are excluded. Outcomes will compare the two groups to see whether the 3D models produce measurable improvements in informed consent and patient experience.
Why it matters
Potential benefit: If successful, the 3D-printed models could help patients better understand their surgery, feel less anxious before the operation, and be more satisfied with communication and consent.
How similar studies have gone: Small studies and pilot reports have suggested 3D-printed anatomical models can improve patient understanding and satisfaction in surgical settings, but randomized evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
King Abdulaziz University Dental Hospital
Jeddah, Saudi Arabia Recruiting -
Razan Baabdullah
Jeddah, Mecca Region, Saudi Arabia Completed
Study contacts
- Principal investigator: Razan M Baabdullah, BDS,MS,FRCDC — King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
- Study coordinator: Razan M Baabdullah, BDS,MS,FRCDC
- Email: rmsbaabdullah@kau.edu.sa
- Phone: +96655501567
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.