Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery

Not Applicable

Recruiting

• Conditions: Skeletal Deformities; Orthognathic Surgical Procedures; Anxiety; Patient Education

• Registration Number: NCT07068412
• Lead Sponsor: King Abdulaziz University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-06
• Last Update Submitted: 2025-07-06
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Razan Baabdullah; 🇸🇦 Jeddah, Makkah, Saudi Arabia

King Abdulaziz University Dental Hospital; 🇸🇦 Jeddah, Saudi Arabia