Augmented Reality for Orthognatic Surgery Patient Education

Patient Satisfaction Clinical Trial

— NARRATE  

Official title:

Augmented Reality for Orthognatic Surgery Patient Education

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140043
• Other study ID #: 17618
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: University Medical Center Groningen
• Contact: S Tabernée Heijtmeijer, MSc.
• Phone: (050) 361 0213|
• Email: s.j.c.tabernee.heijtmeijer[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Patient consultation
Providing information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it.

Locations

Country	Name	City	State
Germany	UniKlinik RWTH Aachen	Aachen
Netherlands	UMC Groningen	Groningen
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	UMC Utrecht, Uniklinik RTWH Aachen

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnosis	Orthognatic diagnosis	During the first intake consult
Other	Occlusion Class	Class of the occlusion of the patient before surgery	During the first intake consult
Primary	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
Primary	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