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Enrolling by invitation NCT07012850

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

— Observational Traumatology Maxillofacial Trauma Maxillofacial Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Traumatology, Maxillofacial Trauma, Maxillofacial Injuries. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Magnetic Resonance Imaging
    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 outcome measures

  • qualitative imaging parameters [Time frame: From enrollment to the end of treatment at week 5]
  • Quantitative Assessment of Fracture Dimensions [Time frame: From enrollment to the end of treatment at week 5]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Department of Cranio-Maxillofacial and Oral Surgery, University Hospital Zurich — Zurich

Publications

  • Al-Haj Husain A, Sandhu S, Burian E, Precht MM, Sommer S, Frauenfelder T, Wagner MEH, Essig H. Intraoperative C-arm CBCT versus early postoperative MRI for the assessment of fracture reduction and osteosynthesis material positioning in cranio-maxillofacial trauma surgery. Oral Maxillofac Surg. 2026 Jun 26;30(1):101. doi: 10.1007/s10006-026-01588-8. PMID 42360559
  • Al-Haj Husain A, Kessler P, Lie SAN, Sandhu S, Wagner MEH, Burian E, Zedler D, Precht MM, Sommer S, Frauenfelder T, Essig H. Comparative evaluation of MRI-based bone-targeted sequences and computed tomography for preoperative assessment of midfacial trauma. Sci Rep. 2026 Feb 18;16(1):9700. doi: 10.1038/s41598-026-40252-9. PMID 41708704
  • Al-Haj Husain A, Sandhu S, Wagner MEH, Burian E, Lie SAN, Precht MM, Zedler D, Frauenfelder T, Hotker AM, Stadlinger B, Sommer S, Kessler P, Essig H. Diagnostic performance of CT and MRI in mandibular trauma assessment - a prospective comparative study. Oral Maxillofac Surg. 2025 Dec 27;30(1):12. doi: 10.1007/s10006-025-01496-3. PMID 41454981

Identifiers

NCT: NCT07012850 · 2024-02307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗