Augmented Reality for Orthognatic Surgery Patient Education

Phase 2

Completed

• Conditions: Dentofacial Deformities; Patient Satisfaction; Malocclusion; Informed Consent; Patient Education
• Interventions: Other: Patient consultation

• Registration Number: NCT06140043
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-18
• Primary Completion: 2024-07-30
• Study Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

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

Inclusion Criteria

• Patients planned for an orthognathic intake consult in the period of July to april 2024 at the UMCU or UMCG or Uniklinik RTWH Aachen;
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D Monitor screen	Patient consultation	Patient consultation with 3D models of bone and skin, seen with a monitor screen
3D AR	Patient consultation	Patient consultation with 3D models of bone and skin, seen in augmented reality trough AR glasses

Primary Outcome Measures

Name	Time	Method
Objective knowledge	Immediately after the regular first intake consult	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
Patient satisfaction	Immediately after the regular first intake consult	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

Trial Locations

Locations (3)

UniKlinik RWTH Aachen; 🇩🇪 Aachen, Germany

UMC Groningen; 🇳🇱 Groningen, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands