Augmented Reality for Orthognatic Surgery Patient Education (NARRATE)

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).

Study Overview

• Status: Recruiting
• Conditions: Malocclusion; Patient Satisfaction; Informed Consent; Patient Education; Dentofacial Deformities
• Intervention / Treatment: Other: Patient consultation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: S Tabernée Heijtmeijer, MSc.; Phone Number: (050) 361 0213|; Email: s.j.c.tabernee.heijtmeijer@umcg.nl

Study Locations

• Germany
  • Aachen, Germany
    • Recruiting
    • Uniklinik RWTH Aachen
    • Contact: Behrus Puladi; Email: bpuladi@ukaachen.de
    • Sub-Investigator: Ashkan Rashad
    • Sub-Investigator: Oliver-Costin Vladu
• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • UMC Groningen
    • Contact: S Tabernée Heijtmeijer, MSc.; Email: s.j.c.tabernee.heijtmeijer@umcg.nl
    • Principal Investigator: Joep Kraeima, dr.
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht
    • Contact: N Janssen, dr.; Email: n.g.janssen-2@umcutrecht.nl
    • Sub-Investigator: Noa Nicolai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis	Orthognatic diagnosis	During the first intake consult
Occlusion Class	Class of the occlusion of the patient before surgery	During the first intake consult

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: UMC Utrecht; Uniklinik RTWH Aachen
• Investigators: Principal Investigator: J Kraeima, dr., UMC Groningen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Informed Consent; Patient Education; Augmented Reality; Patient Satisfaction; 3D; BSSO; Orthognatic Surgery; BIMAX
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Malocclusion; Dentofacial Deformities
• Other Study ID Numbers: 17618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No