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NCT Number: NCT07068412

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

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

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Key information

Conditions

Skeletal Deformities Anxiety Anxiety Disorders Mental Disorders Orthognathic Surgical Procedures Patient Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Razan Baabdullah, Jeddah, Mecca Region, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-printed Orthognathic Surgical Simulation

Combination Product

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.

Other names: 3d-printed anatomical models

2D Visual Representations of Skeletal Movements in Orthognathic Surgery

Combination 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anxiety level

    Time frame: 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.

  2. Patient-doctor relationship

    Time frame: 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).

  3. Patient Satisfaction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Razan M Baabdullah, BDS,MS,FRCDC

CONTACT

[email protected]

+96655501567

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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