Augmented Reality for Orthognatic Surgery Patient Education

NCT06140043 | Completed Phase 2 DMC

• 1 other identifier: 17618
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

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).

Conditions

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

Keywords

Orthognatic Surgery; Augmented Reality; Patient Satisfaction; Informed Consent; Patient Education; 3D; BSSO; BIMAX

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Diagnosis

  During the first intake consult

• Occlusion Class

  During the first intake consult

Study Arms (2)

Monitor

ACTIVE COMPARATOR

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

Other: Patient consultation

Augmented Reality

EXPERIMENTAL

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

Other: Patient consultation

Interventions

Patient consultation OTHER

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

Augmented Reality; Monitor

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with craniofacial syndromes, such as cleft lip and palate
• Patient which require an osteotomy involving two or more segments

Sponsors & Collaborators

• University Medical Center Groningen: lead
• UMC Utrecht: collaborator
• Uniklinik RTWH Aachen: collaborator

Study Sites (3)

UniKlinik RWTH Aachen

Aachen, Germany

Location

UMC Groningen

Groningen, Provincie Groningen, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, Netherlands

Location

MeSH Terms

Conditions

Malocclusion; Dentofacial Deformities; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• J Kraeima, dr.

  UMC Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients are randomised to one of two groups, either consultation with models on a computer screen or with models shown in augmented reality

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 18, 2023
• Study Start: October 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: October 1, 2024
• Last Updated: March 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (2)