Clinical trial NCT07012850: Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma
Official title: Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Traumatology
Maxillofacial Trauma
Maxillofacial Injuries
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population from the University Hospital Zurich, Switzerland

Brief summary: Dental, oral, and maxillofacial trauma represents a significant public health concern, with most cases resulting from accidents and occurring frequently in young adults. Diagnosis relies on clinical examination and imaging modalities like computed tomography (CT) and cone-beam computed tomography (CBCT), which are standard for hard tissue assessment but expose patients to ionizing radiation. To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks, especially beneficial for younger patients. This study aims to assess MRI's diagnostic capabilities for maxillofacial trauma, focusing on early diagnosis, artifact reduction, and comparison to conventional X-ray-based imaging, within a minimal-risk study framework.

This study aims to evaluate the diagnostic efficacy of MRI compared to X-ray-based imaging modalities (CT/CBCT) for detecting dental, oral, and maxillofacial fractures, with a specific focus on Black Bone and CT-like MRI techniques. Additionally, it investigates MRI's potential to reduce artifacts around osteosynthesis plates, enhancing postoperative imaging quality in the presence of metal hardware.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with acute dental, oral and maxillofacial trauma
* Age: 18 years and older
* Able to give informed consent (documented by signature)
* No prior radiation-based imaging for the current trauma episode

Exclusion Criteria:

* Pregnant or lactating individuals
* Known contraindications to MRI (e.g., pacemakers, certain implants)
* Clinically significant concomitant diseases affecting imaging quality (e.g., severe neurocognitive disorders)
* Inability to comply with MRI procedures or study protocol (e.g., due to language barriers, psychological disorders, or dementia)
* Participation in other clinical trials that may interfere with the imaging study

Primary outcomes:
measure: qualitative imaging parameters
timeFrame: From enrollment to the end of treatment at week 5
measure: Quantitative Assessment of Fracture Dimensions
timeFrame: From enrollment to the end of treatment at week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Cranio-Maxillofacial and Oral Surgery, University Hospital Zurich
Study officials:
References: