What is the Scope for Low Field MRI to Replace Cone Beam Computed Tomography in Dentistry?
Conditions: Dental Situations
Sponsor: King's College London

 
 
 
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Protocol details 
1.1 
PROTOCOL TITLE: What is the scope for low field MRI to replace cone beam 
computed tomography in dentistry? 
1.2 
 Names (titles), roles and contact details of: 
Sponsor 
Name of Sponsoring Organisation/s: Guy’s and St Thomas’s NHS Foundation Trust 
Name of Sponsor Representative: Rachel Fay 
Address: Guy's & St Thomas' Foundation NHS Trust, R&D Department,  
16th Floor, Tower Wing, Great Maze Pond,  
London SE1 9RT  
Telephone: 020 7188 7188 
Email: R&D@gstt.nhs.uk 
 
Co-sponsor  
Name of Sponsoring Organisation/s: King’s College London 
Name of Sponsor Representative: Professor Bashir Al-Hashimi 
Vice President & Vice Principal (Research) 
Address: King’s College London 
Room 8.11 8th Floor Melbourne House 44-46 Aldwych 
London WC2B 4LL 
Telephone: +44 (0)207 8487306 
Email: vpri@kcl.ac.uk 
 
 
Chief Investigator  
Name: Dr. Saoirse O’Toole 
 
Address: Guy’s and St Thomas’s NHS Foundation Trust, Floor 18, Tower Wing, London, 
SE19RT 
Email: saoirse.otoole@kcl.ac.uk 
 
Name and address of Investigator(s) (add additional names as necessary) 
Name: Dr Jonathan Davies  
Address: Floor 23, Tower Wing SE19RT 
Email: Jonathan.davies@gstt.nhs.uk 
 
Name: Prof Jo Hajnal  
Address: Department of Perinatal Imaging and Health, Floor 1, South Wing 
St Thomas’ Hospital 
Westminster Bridge Road, London, SE1 7EH 
Email: Jo.hajnal@kcl.ac.uk 
 
 
 
 

 
 
 
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Name: Dr. Vinod Patel 
Address: Floor 23, Tower Wing SE19RT 
Email: vinod.patel@kcl.ac.uk 
 
Name: Dr Steve Connor 
Address: Floor 2, Tower Wing SE19RT 
Email: steve.connor@gstt.nhs.uk 
 
Name: Dr Owen Addison  
Address: Guy’s and St Thomas’s NHS Foundation Trust, Floor 18, Tower Wing, London, 
SE1 9RT 
Email: owen.addison@kcl.ac.uk 
 
Name: Prof Rubens Spin-Neto 
Address: Centre for Clinical, Oral and Translational Sciences, Floor 18, Tower Wing, 
London, SE1 9RT 
Email: rubens.spinneto@kcl.ac.uk 
 
1.3 Protocol details 
Version number: 1.0 
Final/draft: Final 
Date: 14/03/2025 
 
 

 
 
 
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2 Signature Page 
 
The Chief Investigator and the R&D (sponsor office) have discussed this protocol. The 
investigators agree to perform the investigations and to abide by this protocol  
 
Chief investigator 
[Insert name of CI] 
 
 
 
Signature 
Date 
Sponsor Representative 
R&D to Add  
 
 
GSTFT 
Signature 
Date 
 
 
 
 
This Protocol template is intended for use with UK sites only. 

 
 
 
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Contents Page 
Protocol details ...................................................................................................................................... 1 
1.1 
PROTOCOL TITLE: .................................................................................................................. 1 
1.2 
Names (titles), roles and contact details of: ......................................................................... 1 
1.3 
Protocol details ..................................................................................................................... 2 
2 
Signature Page ................................................................................................................................ 3 
Contents Page ........................................................................................................................................ 4 
3 
List of Abbreviations and Definitions ............................................................................................. 6 
4 
Summary/Synopsis ......................................................................................................................... 7 
Introduction ........................................................................................................................................... 8 
5 
Trial objectives and purpose .......................................................................................................... 8 
6 
Study design & Flowchart ............................................................................................................... 9 
6.1 
Study Design ......................................................................................................................... 9 
6.2 
Flowchart ............................................................................................................................ 10 
7 
Subject selection .......................................................................................................................... 10 
7.1 
Subject inclusion criteria ..................................................................................................... 10 
7.2 
Subject exclusion criteria .................................................................................................... 10 
8 
Study procedures ......................................................................................................................... 11 
8.1 
Subject recruitment ............................................................................................................ 11 
8.2 
Imaging Procedures ............................................................................................................ 11 
8.3 
Masking & other measures taken to avoid bias .................................................................. 12 
8.3.1 
Masking .......................................................................................................................... 12 
8.4 
Patient and Clinician Acceptability ...................................................................................... 12 
8.5 
Health Economics ................................................................................................................ 12 
8.6 
End of Study Definition ....................................................................................................... 12 
9 
Assessment of Safety .................................................................................................................... 12 
9.1 
Ethics Reporting .................................................................................................................. 13 

 
 
 
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9.2 
Trial Steering Committee .................................................................................................... 13 
9.3 
Ethics & Regulatory Approvals ............................................................................................ 13 
10 
Compliance and withdrawal .................................................................................................... 13 
10.1 
Subject compliance ............................................................................................................. 13 
10.2 
Withdrawal / dropout of subjects ....................................................................................... 14 
10.3 
Protocol Compliance ........................................................................................................... 14 
11 
Data ......................................................................................................................................... 14 
11.1 
Data to be collected ............................................................................................................ 14 
11.2 
Data handling and record keeping ...................................................................................... 16 
12 
Statistical considerations ......................................................................................................... 16 
12.1 
Data monitoring .................................................................................................................. 17 
13 
Ethical considerations ............................................................................................................. 17 
14 
Financing and Insurance .......................................................................................................... 17 
15 
Reporting and dissemination .................................................................................................. 17 
 

 
 
 
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3 List of Abbreviations and Definitions 
 
AE 
 
 
Adverse Event 
 
 
AR 
 
 
Adverse Reaction 
ASR 
 
 
Annual Safety Report 
CA 
 
 
Competent Authority 
CI 
 
 
Chief Investigator 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organisation 
DMC  
 
Data Monitoring Committee 
EC 
 
 
European Commission 
GAfREC 
 
Governance Arrangements for NHS Research Ethics Committees 
ICF 
 
 
Informed Consent Form 
ISRCTN 
 
International Standard Randomised Controlled Trial Number 
MA 
 
 
Marketing Authorisation 
MS 
 
 
Member State 
Main REC 
 
Main Research Ethics Committee 
NHS R&D 
 
National Health Service Research & Development   
PI 
 
 
Principal Investigator 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
Participant 
 
An individual who takes part in a clinical trial 
RCT 
 
 
Randomised Controlled Trial 
REC 
 
 
Research Ethics Committee 
SAE 
 
 
Serious Adverse Event 
SDV 
 
 
Source Document Verification 
SOP 
 
 
Standard Operating Procedure  
SSA 
 
 
Site Specific Assessment 
TMG  
 
Trial Management Group 
TSC 
 
 
Trial Steering Committee 
 
 

 
 
 
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4 Summary/Synopsis 
 
Title  
 
 
What is the scope for low field MRI to replace cone beam computed 
tomography in dentistry? 
Protocol Short Title/Acronym 
 
DDMRI 
Protocol Version number and Date 
 
V1.0 14/03/2025 
Study Phase if not mentioned in title 
 
Prospective cohort study 
Is the study a Pilot? 
 
Yes 
IRAS Number 
 
304665 
REC Reference 
 
TBC 
Sponsor Reference 
 
EDGE 166436 
Study Duration 
 
24 months 
Methodology 
 
 
Feasibility investigation of a new imaging modality 
Sponsor name 
 
Guy’s and St-Thomas’ Foundation Trust and King’s College London 
Chief Investigator 
 
Dr. Saoirse O’Toole 
Funder Name 
 
N/A 
Medical condition or disease under 
investigation 
 
Orofacial Pathologies 
Purpose of research study 
 
To optimise imaging parameters and assess diagnostic value of MRI in 
orofacial conditions 
Primary objective 
 
To determine the diagnostic accuracy of MRI compared to standard of 
care 
Secondary objective (s) 
 
To optimise imaging parameters and assess health resource use 
Number of Subjects/Patients 
 
50  
Trial Design  
 
Comparative effectiveness trial 
Endpoints 
 
Software parameters and applications assessed for delivery of 
standard of care 
Main Inclusion Criteria 
 
Patients requiring imaging of an orofacial pathology 
Statistical Methodology and Analysis 
 
This is a feasibility study. Initial qualitative assessments of diagnostic 
accuracy will be made. 
We will then use simple descriptives assessing the number of patients 
who were eligible to use the radiation free imaging modality (MRI) and 
those that required further conventional radiography. 
Health resource use will also be documented and compared using 
simple descriptives as part of this pilot investigation. 
 
 
 
 

 
 
 
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Introduction 
Magnetic Resonance Imaging (MRI) has emerged as a powerful diagnostic tool that offers 
numerous 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 provides a wealth of benefits, including superior soft tissue visualization, 
multiplanar imaging capabilities, and the absence of ionizing radiation. Furthermore, MRI 
enables the detection and characterization of a wide range of pathologies with exceptional 
accuracy, leading to improved diagnostic capabilities and better patient outcomes.  
To date, the use of MRI in dentistry has been limited. This is due to several reasons 
1. Cost: MRI machines are expensive to purchase, operate, and maintain. The high cost 
associated with MRI equipment and procedures makes it less feasible for routine 
dental imaging, where other more cost-effective imaging modalities like conventional 
2D X-rays and Cone Beam Computed Tomography (CBCT) are available. 
2. Accessibility: MRI machines are larger and require more space compared to dental 
radiographic equipment.  
3. Time: MRI scans can take longer to perform compared to other imaging modalities. 
The longer scan times associated with MRI have, to-date, been impractical in a dental 
setting. 
4. Hard tissue focus: MRI imaging is typically suited for examining soft tissues, such as 
muscles, ligaments, and organs. In dental applications, the primary focus is on the 
teeth and jawbones, which can be easily visualized with conventional X-rays or CBCT. 
Typical MRI machines have not provided the same level of detail and resolution for 
dental structures as these other modalities. 
 
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, without the use of exogenous contrast 
agents. 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. We will be getting a CE marked 
coil and present its documents. We will use the coil in the manner it is certified for to run 
standard Siemens protocols on selected patients under a stated ethics. The aim is to get 
exploratory data so we can better understand how to optimise clinical examinations in the 
future.  
5 Trial objectives and purpose 
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. 

 
 
 
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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 
6 Study design & Flowchart 
6.1 Study Design 
This will be a single-centre, tertiary care based, interdisciplinary prospective cohort study. 
Patients requiring orofacial imaging, provided their treating clinician would see significant 
value in obtaining an MRI image, will be invited to take a dental-dedicated MRI scan in 
addition to conventional dental radiography. The diagnostic value of the MRI scan will be 
graded by the treating clinician. Separately a member of the research team will grade the scan 
quality and diagnostic value and also provide a diagnostic report relating to the data collected. 
Data will be collected on age, gender, ethnicity, medical condition etc and the number of 
patients who could be effectively diagnosed using dental-dedicated MRI alone, versus those 
who needed an additional scan modality such as a Cone Beam CT or conventional CT will be 
documented.  
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. 
Secondary outcomes 
We will also record: 

 
 
 
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1. Whether the diagnosis could have been obtained using dental-dedicated MRI alone 
2. Differences in scanning time 
3. Differences in radiation exposure 
4. Health resources used 
5. Patient visual analog scale when they use both modalities 
 
6.2 Flowchart 
  
Initial 
Consultation 
Visit 1: MRI scan 
Visit 2: 
Reassessment  
Eligibility checked by treating clinician and 
research dentist  
x 
  
  
Conventional Radiography obtained (3-5 
min) 
x 
 
 
Patient Information sheet given (1 min) 
x 
  
  
Consent for additional screening 
procedures (5 min) 
x 
  
  
MRI Scan (10-20 min) 
  
x 
  
Patient VAS questionnaire (<1 min) 
 x 
x 
 
Treating clinician assesses report and 
diagnostic value of MRI 
  
  
 x 
Advises patient of diagnosis (5-10min) 
  
  
 x 
Document Health Resource Use 
 x 
x 
x 
 
7 Subject selection 
This will be a single-centre, tertiary care based, interdisciplinary prospective cohort study. 
Participants will be recruited from King’s Health Partners Dental Service. Potential 
participants will be identified by the direct care team at their consultation in clinic. Patients 
(or their carers/guardians) referred for investigation of an orofacial pathology which may 
have a soft tissue pathological component will be informed by their direct care team that they 
or their child may be eligible to be imaged using a novel, radiation-free imaging modality and 
asked if they would like to speak to a research dentist or nurse about participation. 
 
7.1 Subject 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 
7.2 Subject exclusion criteria  
1. Patient or their carer is unable to show Gillick competency for consent. 
2. The patient has pronounced claustrophobia. 

 
 
 
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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. 
8 Study procedures 
8.1 Subject recruitment 
Initial Consultation 
Participants will be recruited from Guy’s and St Thomas’s Hospital dental services. Potential 
participants will be identified by the direct care team before or at their consultation visit in 
clinic by assessing their follow up status or referral letter. Patients or the guardian/carers of 
patients who require dental imaging of an orofacial pathology with a possible soft tissue 
pathological component will be informed by the direct care team that they may be eligible to 
be imaged using a novel radiation-free dental MRI scan in addition to conventional 
radiography. 
Interested participants will then be asked additional questions about claustrophobia, 
previous implant history and piercings. Most dental implants are non ferromagnetic – making 
them perfectly safe to enter an MRI scanner, as are orthodontic brackets, but their stability 
should be checked prior to the scan. Eligibility of all screened participants will be assessed 
according to the inclusion and exclusion criteria. They or their parents will then be provided 
with a patient information sheet and given a minimum of 24 hours to make their decision.  
8.2 Imaging Procedures  
Visit 1  
If participants agree to take part in the study, they will be given a separate appointment at 
the Advanced MRI centre at St Thomas’s Hospital. Full written informed consent will be 
obtained by the research nurse or dentist and, participants will undergo a brief screening by 
the MRI radiographer to ensure that they have no implants or piercings in place. They will 
then undergo a dental-dedicated MRI scan, which does not include the use of exougenous 
contrast agents. This will be directly uploaded onto the patient’s permanent medical file via 
the current cloud-based, secure Patient Archiving and Communicating System (PACS) called 
Epic. A VAS questionnaire of Magnetic Resonance Imaging  and conventional radiographic 
imaging acceptability will be given to the patient.  An oral maxillofacial radiologist will review 
the scan and make a report in conjunction with a neuroradiologist/head and neck radiologist 
if required.  

 
 
 
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Visit 2 
At their follow up consultation, the treating clinician will have access to the dental-dedicated 
MRI and report. It will then assess if the diagnosis has changed in the light of the MRI report. 
Pathologies visible on the dental-dedicated MRI will be compared to pathologies visible on 
the conventional radiography. Clinicians will then be given a clinician Likert questionnaire.   
8.3 Masking & other measures taken to avoid bias 
8.3.1  Masking 
An independent oral maxillofacial radiologist will review the dental-dedicated MRI scan and 
inspect if the scan was of sufficient diagnostic value independent of the conventional 
radiography. In the case of a disagreement between the clinician and oral maxillofacial 
radiologist, a third clinician or oral maxillofacial radiologist will be invited to give a third 
opinion. 
8.4 Patient and Clinician Acceptability 
VAS scores of imaging modality accepatability from patients will be compared 
Clinician likert scores of MRI accepatability will be recorded.  
8.5 Health Economics  
During this feasibility phase, we will collect simple descriptives on health resource use on an excel 
spreadsheet.  
8.6 End of Study Definition  
The end of study is defined as when the diagnostic quality of the dental MRI machine/scans 
has been assessed, a signal of clinical efficacy has been obtained and health economic 
resource use has been documented to enable power calculations for a definitive health 
technology assessment. 
9  Assessment of Safety  
All adverse events (AEs) will be recorded from when the participant was first enrolled in the study. 
AEs will be classified according to severity and whether related to the study intervention. The 
Medicines for Human Use (Clinical Trials) Regulations 2004 and Amended Regulations 2006 gives the 
following definitions: 
• 
Adverse Event (AE): Any untoward medical occurrence in a participant to whom a medicinal 
product has been administered, including occurrences which are not necessarily caused by or related 
to that product. 
• 
Serious adverse Event (SAE): Any adverse event that: 
o 
results in death; 

 
 
 
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o 
is life-threatening; 
o 
required hospitalisation or prolongation of existing hospitalisation; 
o 
results in persistent or significant disability or incapacity; 
o 
consists of a congenital anomaly or birth defect. 
 
• 
Important Medical Events (IME) & Pregnancy: Events that may not be immediately life-
threatening or result in death or hospitalisation but may jeopardise the participant or may require 
intervention to prevent one of the other outcomes listed in the definition above should also be 
considered serious. Although not a serious adverse event, any unplanned pregnancy will also be 
reported via the SAE reporting system. 
All SAEs will be reported immediately by the Chief Investigator (and no later than 24hrs) to the GSTT 
R&D office (Sponsor). 
 
9.1  Ethics Reporting 
Reports of related and unexpected SAEs will be submitted to the Main REC within 15 days of the chief 
investigator becoming aware of the event, using the NRES template. The form will be completed in 
typescript and signed by the chief investigator. The main REC will acknowledge receipt of safety 
reports within 30 days. A copy of the SAE notification and acknowledgement receipt will be  sent to 
the R&D Directorate.  
9.2 Trial Management Group 
There is an inter-disciplinary research team of clinical academics consisting of dentists, oral surgeons, 
oral and maxillofacial radiologists and neurologist. If any safety concerns become apparent there will 
be an emergency meeting set up for optimal care or changes to the protocol. The chief investigator is 
responsible for trial oversight.  
9.3 Ethics & Regulatory Approvals 
The trial will be conducted in compliance with the principles of the Declaration of Helsinki (1996), 
the principles of GCP and in accordance with all applicable regulatory requirements including but not 
limited to the Research Governance Framework and the Medicines for Human Use (Clinical Trial) 
Regulations 2004, as amended in 2006 and any subsequent amendments. 
This protocol and related documents (PIS, ICF and MRI report template) will be submitted for review 
to Research Ethics Committee (REC) under the HRA.  
10 Compliance and withdrawal 
10.1 Subject compliance 
Compliance with the dental MRI scan will be assessed by recording the number of patients who were 
booked in for a scan versus the number of patients who did not complete the scan.  
If the patient is unable to comply with the device, conventional radiography will be performed.  

 
 
 
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10.2 Withdrawal / dropout of subjects 
Participants will be free to withdraw at any stage of their assessment journey with no impact to their 
clinical care. If a patient withdraws, drops out or loses capacity to consent/assent, data that has been 
deidentified will be retained for analysis. Data will be analysed per protocol. If a patient withdraws 
prior to receiving the MRI scan, they will return to standard of care and another participant will be 
recruited. 
10.3 Protocol Compliance  
All non-compliances with the protocol will be documented. As this is a feasibility study any deviations 
from the protocol will be discussed with our PPI group and research team and will inform definitive 
care protocols.  
 
11 Data 
11.1 Data to be collected 
Data Collection Table 
Variable 
Source of data 
Collection time 
point(s) 
Who will collect 
data 
Validity of 
tool 
Form data 
will take 
Primary Outcome 
Percentage of 
patients whose 
diagnosis/care 
changed as a 
result of their 
dental MRI 
scan 
Documenting 
numbers of 
those whose 
diagnosis 
based upon 
conventional 
radiography 
changed after 
reviewing the 
dental MRI 
scan compared 
to the total 
number 
receiving the 
MRI scan 
At patient’s 
conventional 
radiography  
appointment 
and at patient’s 
follow up visit 
The research 
team 
Simple 
demographics 
Numeric 
Secondary Outcomes 
Percentage of 
patients who 
would have 
been able to 
complete their 
diagnosis with 
a dental MRI 
scan alone 
Documenting 
numbers of 
those where 
the diagnostic 
value provided 
by the MRI was 
sufficient 
At patient’s 
follow up visit 
The research 
team 
Simple 
demographics 
Numeric 

 
 
 
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without the 
need for 
conventional 
radiography 
Percentage of 
eligible 
patients who 
agreed to have 
an dental MRI 
scan 
Documenting 
numbers of 
those meeting 
the elligibily 
criteria versus 
those who 
agreed to have 
an MRI scan 
After screening 
has taken place 
The research 
team 
Simple 
demographics 
Numeric 
Percentage of 
patients who 
completed the 
dental MRI 
scan 
Documenting 
numbers of 
those who 
were scanned 
and those who 
completed the 
scan 
After the 
patients who 
were recruited 
to the trial 
complete the 
second 
gastroenterology 
assessment 
appointment 
The research 
team 
Simple 
demographics 
Numeric 
Patient 
acceptability of 
the imaging 
modality (as 
determined by 
VAS scale  
Patient VAS 
scale  
After each scan 
was taken 
The research 
team 
Simple 
descriptives 
Numeric 
Documentation 
of Health 
resource use 
including 
intervention 
costs 
Documentation 
of resources 
used to include 
average 
appointment 
times and 
attending 
health care 
practitioners 
Throughout trial 
Research team 
N/A 
N/A 
 
 

 
 
 
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11.2 Data handling and record keeping 
 
The actual medical scan and report will be uploaded onto the patients medical file and stored within 
the trust PACS following their standard protocols. SSL-encrypted data transmission over NHS e-mail 
when communicating with NHS practices will be employed. All data surrounding the trial will be 
entered into a secure password protected online excel sheet by a clinical research dentist. Clinical scan 
data used for analysis will be pseudoanonymised. Scans will have all identifiers removed and a 
participant ID assigned so that no combination of variables will allow an individual to be directly or 
indirectly identified. A codesheet linking participant ID with their consent form will be held in a locked 
filing cabinet in the PI’s locked office. This will not be shared with KCL. An overview of the data flow is 
shown below 
 
 
 All data storage will be follow this anonymisation protocol and data will be backed up onto a secure 
RAID server with restricted access. De-identified data will be published and then the clinical trials data 
will be stored for 25 years by the King’s Health Partners Clinical Trials Office and all data will be 
protected in adherence to the Data Protection Act 2024. The chief investigator and trial team will 
ensure the quality of the data.  
12 Statistical considerations 
This is a feasibility study. Simple descriptives statistics will be done by Dr. Saoirse O’Toole. Baseline 
characteristics will be summarized for all participants. The percentage of participants whose diagnosis 
altered as a result of the dental MRI scan, the percentage of participants where diagnosis could have 

 
 
 
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been made based upon the MRI scan alone will be reported as descriptives. Participants’ uptake of 
and adherence to imaging modalities, as well patient and clinician acceptability will be summarized 
and presented as percentages. 
Correlation studies assessing differences between dental MRI and conventional radiography for 
osteomyelitis in the extremities have high levels of agreement [1]. Using these as part of a power 
calculation meant that small sample sizes (n=7 at 90% power and alpha of 5%). This is a cohort study 
to determine under what circumstances an MRI scan can be used for complete diagnosis of the 
patient, ultimately leading to a full health technology assessment, sample size calculations based upon 
level of agreements are of limited use.  
12.1 Data monitoring 
The trial manager will be in charge of trial governance, data management and monitoring in addition 
to a trial administrator who will contact participants, book appointments, file trial documentation. 
There will be a quarterly group meeting with all investigators, the trial manager and PPI members. All 
data will be collected according to Good Clinical Practice and will adhere to research governance 
guidance. 
13 Ethical considerations 
Ethical approval will be obtained from the HRA. It is highly likely, given that we are offering a radiation 
free imaging modality, that this will be approved. The participant will be informed that the decision to 
participate or not participate in the study will not influence any clinical decision or subsequent care. 
They may withdraw from the study at any stage without affecting care. If a patient requires dental and 
or medical care during the study period, it will be administered by their treating clinician. Adverse 
event monitoring will comply with sponsor procedures.  
14 Financing and Insurance 
The study is co-sponsored by Guys and St Thomas’ NHS Foundation Trust (GSTT) and King’s College 
London (KCL). The sponsors will, at all times, maintain adequate insurance in relation to the study. KCL 
through its’ own professional indemnity (Clinical Trials) & no fault compensation and the GSTT having 
a duty of care to patients via NHS indemnity cover, in respect of any claims arising as a result of 
negligence by its employees, brought by or on behalf of a study participant. 
15 Reporting and dissemination 
Results will be presented at national and international conferences in addition to publishing in high 
impact inter-disciplinary journals. All participants in the research will be directly informed by their 
clinical care team if the results of the MRI impacted on their diagnosis.  
 
Tables, Figures, References 
Appendices 
Including (where relevant): 
Patient information sheet 
Patient consent form 

 
 
 
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Data collection forms and validation information 
Ethics form 
Summary of product characteristics 
Investigators brochure 
 
Useful reading/websites 
 
Integrated Research Application System (IRAS) 
https://www.myresearchproject.org.uk/  
 
Health Research Authority (HRA) 
www.hra.nhs.uk  
 
HRA Guidance for Patient Information Sheet and Informed Consent  
http://www.hra.nhs.uk/research-community/before-you-apply/participant-information-sheets-and-
informed-consent/  
 
CONSORT statement  
A set of recommendations for improving the quality of reports of parallel group randomised trials 
http://www.consort-statement.org/  
 
ICH Harmonised Tripartite Guidelines for Good Clinical Practice (1996) 
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guidel
ine.pdf  
 
Martin Bland et al, Statistical guide for research grant applications 
http://www-users.york.ac.uk/~mb55/guide/guide.htm  
Includes detailed information and definitions of many aspects required for a research protocol as well 
as information about randomisation software and services 
 
Martin Bland, Directory of randomisation software and services 
http://www-users.york.ac.uk/~mb55/guide/randsery.htm  
 
Declaration of Helsinki  
(http://www.wma.net/en/30publications/10policies/b3/index.html) 
 
 

 
 
 
IRAS reference: 328156    
                      Protocol v1.0 14/03/2025                               
Page 19 of 20 
 
Appendix 1 – Information with regards to Safety Reporting in Non-CTIMP 
Research 
 
Who 
When 
How 
To Whom 
SAE 
Chief 
Investigator 
-Report to Sponsor 
within 24 hours of 
learning of the event 
 
-Report to the MREC 
within 15 days of 
learning of the event 
 
SAE Report form for Non-
CTIMPs, available from NRES 
website. 
Sponsor and MREC 
Urgent Safety 
Measures  
Chief 
Investigator  
Contact the Sponsor and 
MREC Immediately 
 
Within 3 days  
By phone 
 
 
 
 
Substantial amendment 
form giving notice in writing 
setting out the reasons for 
the urgent safety measures 
and the plan for future 
action. 
Main REC and 
Sponsor  
 
 
 
Main REC with a 
copy also sent to 
the sponsor. The 
MREC will 
acknowledge this 
within 30 days of 
receipt.  
Progress 
Reports  
Chief 
Investigator  
Annually ( starting 12 
months after the date of 
favourable opinion) 
Annual Progress Report 
Form (non-CTIMPs) available 
from the NRES website 
Main REC 
Declaration of 
the conclusion 
or early 
termination of 
the study 
Chief 
Investigator  
Within 90 days 
(conclusion) 
 
Within 15 days (early 
termination) 
 
The end of study should 
be defined in the protocol 
End of Study Declaration 
form available from the 
NRES website 
Main REC with a 
copy to be sent to 
the sponsor  
Summary of 
final Report  
Chief 
Investigator 
Within one year of 
conclusion of the 
Research 
No Standard Format 
However, the following 
Information should be 
included:- 
Where the study has met its 
objectives, the main findings 
and arrangements for 
publication or dissemination 
including feedback to 
participants 
Main REC with a 
copy to be sent to 
the sponsor 

 
 
 
IRAS reference: 328156    
                      Protocol v1.0 14/03/2025                               
Page 20 of 20