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

NCT ID: NCT07012850

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatology Maxillofacial Trauma Maxillofacial Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harald Essig

OTHER

Sponsor Role lead

Responsible Party

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Harald Essig

Prof. Dr. med. Dr. med. dent.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2024-02307

Identifier Type: -

Identifier Source: org_study_id

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