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OpenTrials
Completed

NCT Number: NCT06140043

Augmented Reality for Orthognatic Surgery Patient Education

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).

Completed

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Key information

Conditions

Malocclusion Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dentofacial Deformities Health Behavior Informed Consent Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Patient Education Patient Satisfaction Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases Treatment Adherence and Compliance

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UniKlinik RWTH Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient consultation

Other

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

Primary outcomes

  1. 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

  2. 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

Other outcomes

  1. Diagnosis

    Time frame: During the first intake consult

    Orthognatic diagnosis

  2. Occlusion Class

    Time frame: During the first intake consult

    Class of the occlusion of the patient before surgery

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • UMC Utrecht
  • Uniklinik RTWH Aachen

Registry information

Acronym: NARRATE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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