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

NCT07012850 | Enrolling By Invitation DMC

• 1 other identifier: 2024-02307
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatology; Maxillofacial Trauma; Maxillofacial Injuries

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

  From enrollment to the end of treatment at week 5

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population from the University Hospital Zurich, Switzerland

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harald Essig: lead

Study Sites (1)

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

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Maxillofacial Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Dr. med. dent.

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 10, 2025
• Study Start: May 5, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Locations

CH (1)