Clinical trial NCT07008014: Can Dental Dedicated MRI Replace Low-dose CBCT Scanning in Dentistry
Official title: What is the Scope for Low Field MRI to Replace Cone Beam Computed Tomography in Dentistry?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Situations
Keywords: Dental
MRI
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring orofacial imaging or healthy volunteers, provided their treating clinician would see significant value in obtaining an MRI image

Brief summary: Magnetic Resonance Imaging (MRI) has is a useful diagnostic tool that offers advantages over conventional radiography techniques. Unlike traditional X-ray or computed tomography (CT) scans, MRI utilizes a magnetic field and radio waves to generate detailed and high-resolution images of the body's internal structures. This non-invasive imaging modality allows you to better see soft tissues in 3D without the use of ionising radiation. Furthermore, MRI enables the detection and characterization of a wide range of pathologies which can lead to improved diagnostic capabilities and better patient outcomes.

To date, the use of MRI in dentistry has been limited as dentistry imaging focuses predominantly on hard tissues (teeth and bones) in addition to the higher cost and accessibility issues with MRI machines.

However, recent developments have led to the development of a dental-specific coil for use with a low field strength (0.55 Tesla) MRI scanner. This has resulted in high diagnostic quality soft and hard tissue images and reduced imaging time. As this imaging modality has rarely been used before in dentistry, the aim of this study is to investigate its use for dental imaging, refining parameters and assessing the diagnostic quality of dental scans taken using MRI and the specific dental coil.

Detailed description: The overall aim of this feasibility project is to optimise MRI parameters for dental use (i.e., dental-dedicated MRI)and assess the diagnostic quality of dental scans taken using MRI.

The objectives are to assess if MRI imaging has altered the diagnosis, retrospectively analyse the numbers of patients which can be diagnosed effectively using this radiation free imaging modality and document health resource use to inform a full health technology assessment trial.

The primary objective is to assess the feasibility of providing MRI scanning to dental patients and the resultant benefit. As such we will examine the percentage of patients whose diagnosis was altered as a result of additional MRI scanning.

The secondary objectives are to assess:

1. The percentage of patients who would have been able to complete their diagnosis with an MRI scan alone
2. Percentage of eligible patients who agreed to have an MRI scan
3. Percentage of patients who completed the MRI scan
4. Clinician rated diagnostic acceptability
5. Patient acceptability of the imaging modality (as determined by VAS scale)
6. Documentation of Health resource use including intervention costs

Eligibility criteria: Inclusion Criteria:

1. Patients aged 3 or over with suspected orofacial pathology involving a soft tissue component or healthy volunteers
2. The patient is willing to undergo an MRI investigation
3. Patient or their carer/guardian is able to provide informed consent to the study

Exclusion Criteria:

1. Patient or their carer is unable to show Gillick competency for consent.
2. The patient has pronounced claustrophobia.
3. The patient has a pacemaker or implanted defibrillator.
4. The patient has history of metal shrapnel injuries to the eyes or MRI incompatible metallic inclusions or implants/ large tattoos.
5. The patient has non-removable piercings.
6. Pregnant patients, or patients who suspect they could be pregnant
7. The patient has participated in other research studies within the previous 30 days.

Primary outcomes:
measure: Percentage of patients whose diagnosis/care changed as a result of the additional dental MRI imaging compared to the total number of patients imaged using conventional radiography.
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage of patients whereby the diagnosis could have been obtained using dental-dedicated MRI alone
timeFrame: 4 weeks
measure: Time spent undergoing scan
timeFrame: 4 weeks
measure: Radiation exposure (Grays)
timeFrame: 4 weeks
measure: Patient visual analog scale when they use both modalities
timeFrame: 4 weeks
Other outcomes:
measure: Identify health resources used
timeFrame: 4 weeks
Locations:
Study officials:
affiliation: King's College London
name: Saoirse O'Toole, BDentSc PhD
role: PRINCIPAL_INVESTIGATOR
References: