Augmented Reality for Orthognatic Surgery Patient Education (NARRATE)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Informed Consent; Patient Satisfaction; Patient Education; Malocclusion; Dentofacial Deformities

Treatments: Other: Patient consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT06140043

17618

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Monitor

Active Comparator group

Description:

Patient consultation with 3D models of bone and skin, seen with a monitor screen

Treatment:

Other: Patient consultation

Augmented Reality

Experimental group

Description:

Patient consultation with 3D models of bone and skin, seen in augmented reality trough AR glasses

Treatment:

Other: Patient consultation