Augmented Reality for Orthognatic Surgery Patient Education

NCT ID: NCT06140043

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

Brief Summary

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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).

Detailed Description

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Conditions

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Malocclusion Dentofacial Deformities Patient Satisfaction Informed Consent Patient Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients are randomised to one of two groups, either consultation with models on a computer screen or with models shown in augmented reality
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Monitor

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

Group Type ACTIVE_COMPARATOR

Patient consultation

Intervention Type OTHER

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

Augmented Reality

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

Group Type EXPERIMENTAL

Patient consultation

Intervention Type OTHER

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

Interventions

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Patient consultation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role collaborator

Uniklinik RTWH Aachen

UNKNOWN

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J Kraeima, dr.

Role: PRINCIPAL_INVESTIGATOR

UMC Groningen

Locations

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UniKlinik RWTH Aachen

Aachen, , Germany

Site Status

UMC Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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17618

Identifier Type: -

Identifier Source: org_study_id

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