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Clinical Trials/NCT06140043
NCT06140043
Completed
Phase 2

Augmented Reality for Orthognatic Surgery Patient Education

University Medical Center Groningen3 sites in 2 countries60 target enrollmentOctober 1, 2023

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Malocclusion
Sponsor
University Medical Center Groningen
Enrollment
60
Locations
3
Primary Endpoint
Objective knowledge
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
October 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Objective knowledge

Time Frame: 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

Patient satisfaction

Time Frame: 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

Study Sites (3)

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