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Augmented Reality for Orthognatic Surgery Patient Education

Augmented Reality for Orthognatic Surgery Patient Education

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06140043
Acronym
NARRATE
Enrollment
60
Registered
2023-11-18
Start date
2023-10-01
Completion date
2024-10-01
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

OTHERPatient consultation

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

Sponsors

UMC Utrecht
CollaboratorOTHER
Uniklinik RTWH Aachen
CollaboratorUNKNOWN
University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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 reality

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfactionImmediately after the regular first intake consultPatient 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 knowledgeImmediately after the regular first intake consultPatient 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

MeasureTime frameDescription
DiagnosisDuring the first intake consultOrthognatic diagnosis
Occlusion ClassDuring the first intake consultClass of the occlusion of the patient before surgery

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026