NARRATE: Augmented Reality for Orthognatic Surgery Patient Education

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06140043

Collaborator

UMC Utrecht (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Malocclusion Dentofacial Deformities Patient Satisfaction Informed Consent Patient Education	Other: Patient consultation	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

patients are randomised to one of two groups, either consultation with models on a computer screen or with models shown in augmented realitypatients 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)

Primary Purpose:

Other

Official Title:

Augmented Reality for Orthognatic Surgery Patient Education

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 2D Monitor screen

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

Other: Patient consultation

Providing information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it.

Experimental: 3D AR

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

Other: Patient consultation

Providing information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it.

Outcome Measures

Primary Outcome Measures

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
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

Other Outcome Measures

Diagnosis [During the first intake consult]
Orthognatic diagnosis
Occlusion Class [During the first intake consult]
Class of the occlusion of the patient before surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.