MalocclusionPhase 2/3NARRATENCT06140043
Augmented Reality for Orthognatic Surgery Patient Education
A Phase 2/3 study testing Patient consultation in people with Malocclusion and Dentofacial Deformities, run by University Medical Center Groningen at 3 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Malocclusion, Dentofacial Deformities, Patient Satisfaction
- What is being tested?
- Patient consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with craniofacial syndromes, such as cleft lip and palate
- Patient which require an osteotomy involving two or more segments
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
UMC Groningen
Groningen, Provincie Groningen
UMC Utrecht
Utrecht, Utrecht
About this study
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).
- Conditions
- Malocclusion, Dentofacial Deformities, Patient Satisfaction, Informed Consent, Patient Education
- Being tested
- Patient consultation
- Keywords
- Orthognatic Surgery, Augmented Reality, Patient Satisfaction, Informed Consent, Patient Education, 3D, BSSO, BIMAX
- Medical subject headings
- Malocclusion, Dentofacial Deformities, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient consultationOther
Providing information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it.
| Study group | Role | What they receive |
|---|---|---|
| Monitor | Active comparator | Patient consultation with 3D models of bone and skin, seen with a monitor screen Receives: Other: Patient consultation |
| Augmented Reality | Experimental | Patient consultation with 3D models of bone and skin, seen in augmented reality trough AR glasses Receives: Other: Patient consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the regular first intake consult
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
Measured: Immediately after the regular first intake consult
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Oct 2023
- Primary completion30 Jul 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Uniklinik RTWH Aachen
- Responsible party
- Sponsor
- Investigators
- J Kraeima, dr., Principal investigator, UMC Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140043
- Sponsor's protocol ID
- 17618
- Acronym
- NARRATE
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabernee Heijtmeijer SJCS, Nicolai NN, Janssen NGN, Kortes JJ, Hinrichs-Puladi BB, Rashad AA, Vladu OO, Pijpker PAJP, Witjes MJHM, Pichardo SECS, Kraeima JJ. Shared decision making using augmented reality a multicentre pilot randomised controlled trial in orthognathic surgery. NPJ Digit Med. 2026 May 2;9(1):520. doi: 10.1038/s41746-026-02688-1.
PubMed 42069961
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality for Orthognatic Surgery Patient Education
- ClinicalTrials.gov ID
- NCT06140043
- Acronym / sponsor ID
- NARRATE / 17618
- Conditions
- Malocclusion, Dentofacial Deformities, Patient Satisfaction, Informed Consent, Patient Education
- Keywords
- Orthognatic Surgery, Augmented Reality, Patient Satisfaction, Informed Consent, Patient Education, 3D, BSSO, BIMAX
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- UMC Utrecht, Uniklinik RTWH Aachen
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Monitor | Active comparator | Other: Patient consultationPatient consultation with 3D models of bone and skin, seen with a monitor screen |
| Augmented Reality | Experimental | Other: Patient consultationPatient consultation with 3D models of bone and skin, seen in augmented reality trough AR glasses |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with craniofacial syndromes, such as cleft lip and palate
- Patient which require an osteotomy involving two or more segments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient consultationProviding information about the current clinical problem of orthognatic surgery patients and the proposed treatment for it. | Other | Augmented Reality, Monitor |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 42069961Tabernee Heijtmeijer SJCS, Nicolai NN, Janssen NGN, Kortes JJ, Hinrichs-Puladi BB, Rashad AA, Vladu OO, Pijpker PAJP, Witjes MJHM, Pichardo SECS, Kraeima JJ. Shared decision making using augmented reality a multicentre pilot randomised controlled trial in orthognathic surgery. NPJ Digit Med. 2026 May 2;9(1):520. doi: 10.1038/s41746-026-02688-1.
- Individual participant dataSharing planned: No
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Kraeima, dr. principal investigator
UMC Groningen
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Patient consultation in people with Malocclusion and Dentofacial Deformities, run by University Medical Center Groningen at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Immediately after the regular first intake consult). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.