An observational study in Traumatology, Maxillofacial Trauma and Maxillofacial Injuries, sponsored by Harald Essig. Enrolling by invitation at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Harald Essig · Observational
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.
22 studies on the registry are indexed under Maxillofacial Injuries; 7 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 10 observational studies indexed under Maxillofacial Injuries.
Browse Maxillofacial Injuries studies →This is the only study on the registry with Harald Essig as lead sponsor.
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Study Population from the University Hospital Zurich, Switzerland
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
qualitative imaging parameters
Primary Outcome Measures: 1. 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)
Time frame: From enrollment to the end of treatment at week 5
Quantitative Assessment of Fracture Dimensions
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).
Time frame: From enrollment to the end of treatment at week 5
Plan to share: Undecided
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