Dental SituationsDDMRINCT07008014
Can Dental Dedicated MRI Replace Low-dose CBCT Scanning in Dentistry
An observational study of Dental Situations, run by King's College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Situations
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 24 Dec 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients requiring orofacial imaging or healthy volunteers, provided their treating clinician would see significant value in obtaining an MRI image
Who may be able to join
- Patients aged 3 or over with suspected orofacial pathology involving a soft tissue component or healthy volunteers
- The patient is willing to undergo an MRI investigation
- Patient or their carer/guardian is able to provide informed consent to the study
Who cannot join
- Patient or their carer is unable to show Gillick competency for consent.
- The patient has pronounced claustrophobia.
- The patient has a pacemaker or implanted defibrillator.
- The patient has history of metal shrapnel injuries to the eyes or MRI incompatible metallic inclusions or implants/ large tattoos.
- The patient has non-removable piercings.
- Pregnant patients, or patients who suspect they could be pregnant
- The patient has participated in other research studies within the previous 30 days.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: What is the Scope for Low Field MRI to Replace Cone Beam Computed Tomography in Dentistry?
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.
Read the 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:
- The percentage of patients who would have been able to complete their diagnosis with an MRI scan alone
- Percentage of eligible patients who agreed to have an MRI scan
- Percentage of patients who completed the MRI scan
- Clinician rated diagnostic acceptability
- Patient acceptability of the imaging modality (as determined by VAS scale)
- Documentation of Health resource use including intervention costs
- Conditions
- Dental Situations
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Dental, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring orofacial imaging | Patients requiring orofacial imaging, provided their treating clinician would see significant value in obtaining an MRI image Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The treatment plan that was given before the MRI scan will be documented. Following review of the MRI by the overseeing consultant, any changes to the treatment plan will be documented. The number of patients whose treatment plan was altered as a result of the scan will be divided by the number of those who received a scan to get a percentage.
Measured: 4 weeks
To assess diagnostic quality of the image
This is a feasibility trial and a new imaging modality for dentistry. Working with MR physicists we will assess image quality and report on areas for improvement
Measured: 6 months
Secondary outcomes (3)
Percentage of patients whereby the diagnosis could have been obtained using dental-dedicated MRI alone
The number of patients whereby the clinical indicators of pathology on the MRI scan were sufficient to gauge the pathology will be assessed. This will be divided by the number of patients who received a scan to get a percentage.
Measured: 4 weeks
Time spent undergoing scan
Time spent undergoing scan (minutes)
Measured: 4 weeks
Radiation exposure (Grays)
Radiation exposure of the imaging modality (Grays)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion24 Dec 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental SituationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saoirse O'Toole, BDentSc PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008014
- Sponsor's protocol ID
- 328156
- Other IDs
- EDGE 166436
- Acronym
- DDMRI
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can publish the results of the data but not participant scans or any identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Scope for Low Field MRI to Replace Cone Beam Computed Tomography in Dentistry?
- ClinicalTrials.gov ID
- NCT07008014
- Acronym / sponsor ID
- DDMRI / 328156
- Conditions
- Dental Situations
- Keywords
- Dental, MRI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The percentage of patients who would have been able to complete their diagnosis with an MRI scan alone
- Percentage of eligible patients who agreed to have an MRI scan
- Percentage of patients who completed the MRI scan
- Clinician rated diagnostic acceptability
- Patient acceptability of the imaging modality (as determined by VAS scale)
- Documentation of Health resource use including intervention costs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring orofacial imaging | – | Other: Magnetic Resonance ImagingPatients requiring orofacial imaging, provided their treating clinician would see significant value in obtaining an MRI image |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring orofacial imaging or healthy volunteers, provided their treating clinician would see significant value in obtaining an MRI image
Key inclusion criteria (3 listed)
- Patients aged 3 or over with suspected orofacial pathology involving a soft tissue component or healthy volunteers
- The patient is willing to undergo an MRI investigation
- Patient or their carer/guardian is able to provide informed consent to the study
Key exclusion criteria (7 listed)
- Patient or their carer is unable to show Gillick competency for consent.
- The patient has pronounced claustrophobia.
- The patient has a pacemaker or implanted defibrillator.
- The patient has history of metal shrapnel injuries to the eyes or MRI incompatible metallic inclusions or implants/ large tattoos.
- The patient has non-removable piercings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingParticipants will receive an additional MRI image in addition to standard of care to investigate if it was a useful imaging modality for their condition | Other | Patients requiring orofacial imaging |
Primary outcome
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.
Time frame: 4 weeks
The treatment plan that was given before the MRI scan will be documented. Following review of the MRI by the overseeing consultant, any changes to the treatment plan will be documented. The number of patients whose treatment plan was altered as a result of the scan will be divided by the number of those who received a scan to get a percentage.
To assess diagnostic quality of the image
Time frame: 6 months
This is a feasibility trial and a new imaging modality for dentistry. Working with MR physicists we will assess image quality and report on areas for improvement
3 secondary outcomes
Percentage of patients whereby the diagnosis could have been obtained using dental-dedicated MRI alone
Time frame: 4 weeks
Time spent undergoing scan
Time frame: 4 weeks
Radiation exposure (Grays)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No. We can publish the results of the data but not participant scans or any identifiers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saoirse O'Toole, BDentSc PhD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Situations, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saoirse O'Toole, BDentSc PhD (+442078485643, saoirse.otoole@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.