Can Dental Dedicated MRI Replace Low-dose CBCT Scanning in Dentistry

NCT ID: NCT07008014

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-24

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 the clinician 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, the investigators 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

Conditions

Dental Situations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients requiring orofacial imaging

Patients requiring orofacial imaging, provided their treating clinician would see significant value in obtaining an MRI image

Magnetic Resonance Imaging

Intervention Type: OTHER

Participants will receive an additional MRI image in addition to standard of care to investigate if it was a useful imaging modality for their condition

Interventions

Magnetic Resonance Imaging

Participants will receive an additional MRI image in addition to standard of care to investigate if it was a useful imaging modality for their condition

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saoirse O'Toole, BDentSc PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Central Contacts

Saoirse O'Toole, BDentSc PhD

Role: CONTACT

saoirse.otoole@kcl.ac.uk

+442078485643

Jonathan Consultant Maxillofacial Radiologist

Role: CONTACT

jonathan.1.davies@kcl.ac.uk

+442078487343

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

EDGE 166436

Identifier Type: OTHER

Identifier Source: secondary_id

328156

Identifier Type: -

Identifier Source: org_study_id