Augmented Reality for Orthognatic Surgery Patient Education

Study Overview
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Brief Summary
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To evaluate whether the use of augmented reality (AR) for visualizing 3D models can be a valuable addition to patient education regarding orthognathic procedures compared to using only 2D visualization (on a computer screen).

Official Title
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Augmented Reality for Orthognatic Surgery Patient Education

Conditions
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Malocclusion, Dentofacial Deformities, Patient Satisfaction, Informed Consent, Patient Education

Intervention / Treatment
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* Other: Patient consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned for an orthognathic intake consult in the period of July to december 2023 at the UMCU or UMCG; Patients with dentofacial deformity (dysgnathia) including: class II malocclusion, class III malocclusion, or open bite; Patients undergoing treatment using BSSO (Bilateral Sagittal Split Osteotomy), Le Fort I, or BIMAX; The planned treatment is either with or without a genioplasty procedures. Patients 16 years of age or older. Exclusion Criteria: Patients with craniofacial syndromes, such as cleft lip and palate Patient which require an osteotomy involving two or more segments

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients are randomised to one of two groups, either consultation with models on a computer screen or with models shown in augmented reality
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D Monitor screen<br>Patient consultation with 3D models of bone and skin, seen with a monitor screen | Other: Patient consultation<br>* Providing information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it.<br>|
| Experimental: 3D AR<br>Patient consultation with 3D models of bone and skin, seen in augmented reality trough AR glasses | Other: Patient consultation<br>* Providing information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction of the intake consult. Focussed on the explanation of the condition and proposed treatment, measured through a questionnaire. The questionnaire measures the clarity and importance of the information for the patient. For both parameters a median score will be calculated between 0 and 5 | Immediately after the regular first intake consult | 
| Objective knowledge | Patient knowledge of the medical problem and proposed treatment, also measured by a questionnaire. Patient can get 2 points when all four question are right, if all questions are answered incorrectly, then -2 points | Immediately after the regular first intake consult | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D, Orthognatic Surgery, Augmented Reality, Patient Satisfaction, Informed Consent, Patient Education, BSSO, BIMAX