Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma

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.

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Key information

Conditions

Traumatology Craniocerebral Trauma Facial Injuries Maxillofacial Injuries Maxillofacial Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cranio-Maxillofacial and Oral Surgery, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

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.

Primary outcomes

qualitative imaging parameters

Time frame: From enrollment to the end of treatment at week 5
Primary Outcome Measures:
- Qualitative Assessment of Imaging Quality
Description: Image quality will be evaluated using a standardized 5-point Likert scale for the following parameters: overall image quality, artifact severity, fracture visibility, and bone-to-soft-tissue contrast. Each parameter will be scored independently.

Unit of Measure: Score on a 5-point Likert scale (1 = poor, 5 = excellent)
Quantitative Assessment of Fracture Dimensions

Time frame: From enrollment to the end of treatment at week 5

Fracture length, width, and depth will be measured in millimeters across axial, sagittal, and coronal planes using standardized digital radiologic tools. Measurements will be taken by two blinded radiologists and averaged.

Unit of Measure: Millimeters (mm).

Sponsors and collaborators

Lead sponsor

Harald Essig

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 10, 2025
Registry last updated: Jun 10, 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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