Introducing diabetes checks in dental settings: a study to explore whether dental settings can be used to identify new cases of prediabetes and diabetes
| ISRCTN | ISRCTN16227718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16227718 |
| IRAS number | 346183 |
| Secondary identifying numbers | CPMS 63817, Grant Code 14583 |
- Submission date
- 09/05/2025
- Registration date
- 19/05/2025
- Last edited
- 19/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
This study aims to evaluate the diabetes risk assessment process in dental settings. One of the reasons to risk assess for a medical condition (type 2 diabetes) in dental settings is that many people see their dentist regularly when they feel healthy. But many people only see their GP when they have a health problem or feel unwell. This may allow dental teams to pick up problems early. Furthermore, patients with periodontitis (severe gum disease) are more likely to have other chronic inflammatory diseases, including type 2 diabetes. So, this may be another reason why dental teams could be used to identify those at risk of diabetes. Although for this study, all dental patients, regardless of their gum health status, will be welcome to participate. If risk-assessing patients for type 2 diabetes in a dental setting is practical and both patients and dental teams think it is a good idea, then it may lead to earlier diagnosis for patients. This, in turn, may mean they can access care sooner. Early identification benefits patients' health and well-being and may also save the NHS money. If this research shows that knowing the patients' gum health status can provide an additional benefit in the screening process, members of the dental team may be best placed to provide this type of risk assessment.
Who can participate?
Patients who are attending for their routine appointment with their dental care professional, are between 40 and 80 years old and are able to give consent to assist in this research. It is also important that patients have not been told by a healthcare professional that they already have diabetes (and have not been tested in the prior 12 months), sickle cell, or sickle cell trait.
What does the study involve?
Patients will be asked to complete a risk questionnaire and will have a finger-prick blood sample collected. Patients will also be asked if they are willing to provide a small saliva sample.
What are the possible benefits and risks of participating?
Benefits: Participating in the study will provide insight into participants' diabetes risk. By supporting the research, they will be helping to advance research into screening for type 2 diabetes in a dental setting. It is hoped that this may lead to early detection of type 2 diabetes and implementation of screening procedures in dental settings.
Risks: There are minimal risks to taking part in this research, although before participating, patients may wish to consider whether they are likely to feel anxious depending on the result of the risk assessment. Some participants may find that being told they may be at risk of diabetes will cause them a degree of stress or anxiety. If this is the case, they may decide you do not want to participate in the study.
Where is the study run from?
The study is run from up to 50 high street dental practices across the UK. It is sponsored by the University of Birmingham, UK.
When is the study starting and how long is it expected to run for?
July 2024 to July 2029
Who is funding the study?
Haleon Plc
Who is the main contact?
Zehra Yonel, Clinical Lecturer and honorary Specialist Registrar in Restorative Dentistry, University of Birmingham, School of Dentistry, z.yonel@bham.ac.uk
Contact information
Public, Scientific, Principal Investigator
Clinical Lecturer and honorary Specialist Registrar in Restorative Dentistry, University of Birmingham, School of Dentistry, 5 Mill Pool Way
Birmingham
B5 7EG
United Kingdom
 ORCID ID |
0000-0002-5477-8315 |
|---|---|
| Phone | +44 (0)1214665128 |
| z.yonel@bham.ac.uk |
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | INtroducing DIabetes Checks in A denTal sEtting–2 |
| Study acronym | INDICATE-2 |
| Study hypothesis | Null hypothesis: Dental settings will not successfully identify new cases of (previously undiagnosed) prediabetes/diabetes |
| Ethics approval(s) |
Approved 05/12/2024, Surrey Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 1048 088 ; surrey.rec@hra.nhs.uk), ref: 24/LO/0830 |
| Condition | Diabetes |
| Intervention | Eligible patients will be identified by the dental practice teams, who will invite those eligible to read the patient information sheet (PIS) about the study and ask any questions they may have. Where practices can email patients in advance of their appointment, they may opt to send eligible participants electronic copies of the PIS and consent form in advance. Where practices do not routinely contact patients in advance of their appointment, the practice receptionist may elect to inform eligible patients on arrival to the practice that the practice is involved in a research study and ask if they are happy to be emailed the PIS. This type of "opportunistic" recruitment would be more aligned with real-world practice if this intervention were to be adopted into routine practice beyond this study. Information posters have been generated that the practices can display in their waiting rooms to highlight the study to patients who may be interested. Those participants who consent to undergo the Risk Assessment process will be invited to complete an electronic risk questionnaire. This will consist of a single electronic survey on the encrypted REDCap platform and will include the questions from the Diabetes Risk Assessment in Dentistry Score (DDS) and the Leicester Risk Assessment score (LRA). All participants, regardless of their score on the questionnaire, will be offered the Point Of Care Test finger-prick blood HbA1c. This will allow the research team to assess the performance of both these Risk Assessment tools in this prospective cohort and validate them both on a UK dental population. Any participant who scores ≥42mmol/mol will be informed that they are potentially at increased risk of Type 2 Diabetes Mellitus and that they would benefit from a formal test and follow-up with their GP. The participant will also be provided with the results from the RA process in the form of a standardised letter and where they provide consent, a standardised letter will be sent to their GP informing them of the study and the patient's POCT result. If a participant withholds consent for the dental team to contact the GP, the participant will be given an additional copy of the letter intended for their GP, such that they can present it to their GP later should they subsequently change their mind. In the event the dental practice does not receive return correspondence from the patient's primary care medical team (GP), further attempts will be made to acquire this information. This information is important for the patient's clinical oral health team to know. Following the initial letter informing the GP of the risk-assessment process and requesting results from any formal diagnostics. If no response is received within 3 months, this will be logged in REDCap. At 3 months, REDCap will then autogenerate an email to the GP practice email address from the dental care team's email address explaining they did not receive follow-up correspondence to their initial letter and requesting the information once again. If there is still no response to the email, one further letter will be sent to the GP practice at 6 months post-risk assessment from the study chief investigator. Patient participants will also be asked to consent to have diabetes data collected directly via NHS Digital, where this is possible, to minimise the burden on GPs. Having completed the RA process, all participants will be contacted for a follow-up survey 1 week post-risk assessment process to understand their views on the process. This follow-up will be via an electronic survey sent to the email address they provide to the research team. For those participants considered high-risk, there will also be a survey sent at 6 weeks post-risk assessment. The follow-up survey will consist of questions relating to: if and how they acted on the information provided by the dental team following the RA process. Also, pertaining to what action was taken by their GP if they sought an appointment with their GP practice following the RA in the dental setting. As per the consent form. For those participants considered high-risk, a letter will be sent to their GMP informing their doctor that the patient had an HbA1c test within the dental practice, and given that it has revealed a score ≥42mmol/mol, they are potentially at risk. This is to keep the GP informed and up-to-date. Given that HbA1c (glycaemic levels) will impact the patient's oral health, in particular periodontitis risk, the participants' dental teams need to be aware of any formal tests for diabetes, the results and any subsequent medications. A request will be made for the GP to share that information (diabetes status, test result and medications/ interventions) with the dental team to aid their onward management of the patient. The research team will also record this information to ensure the validity of the testing process. Where a response isn't received follow-up will be sent to GPs. The final request for information will be sent at 6 months post-risk assessment. Only 1 response is required from the GP in that initial 6-month period. |
| Intervention type | Other |
| Primary outcome measure | Prediabetes/non-diabetic hyperglycaemia (NDH)/diabetes risk is measured using a validated risk assessment questionnaire (LRA/DDS) and Siemens DCA VANTAGE HbA1c point of care test at baseline. Then followed up with referral to GP for definitive testing up to 6 months from baseline. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2024 |
| Overall study end date | 31/07/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 10000; UK Sample Size: 10000 |
| Participant inclusion criteria | 1. To read and understand the PIS and consent form sufficiently well to provide informed consent and to participate in the study 2. To be competent to provide informed consent 3. Patients aged >=40 and <=80 years 4. Have not had a diabetes check in the past 12 months |
| Participant exclusion criteria | 1. Patients aged <40 years or >=80 years 2. Diagnosis of type 1 or type 2 diabetes 3. Diagnosis of sickle cell or sickle cell trait 4. Unable to provide informed consent 5. Pregnant 6. They have knowingly been tested for diabetes in the past 12 months |
| Recruitment start date | 16/12/2024 |
| Recruitment end date | 01/01/2028 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Birmingham
B1 1TX
United Kingdom
Workington
CA14 2UX
United Kingdom
Sunderland
SR4 7EY
United Kingdom
Dunstable
LU6 1SE
United Kingdom
Dunfermline
KY12 7AR
United Kingdom
Wolverhampton
WV6 9EH
United Kingdom
Stroud
GL5 2AJ
United Kingdom
Orbital Retail Park
Thamesdown Drive
Swindon
SN25 4AN
United Kingdom
Sheffield
S9 4LP
United Kingdom
Plymouth
PL6 8BT
United Kingdom
Evesham
WR11 1BG
United Kingdom
Glossop
SK13 8NN
United Kingdom
Alfreton
DE55 7BR
United Kingdom
Harpenden
AL5 2HU
United Kingdom
Staveley, Chesterfield
S43 3UX
United Kingdom
Hitchin
SG5 1NQ
United Kingdom
Norwich
NR7 0UD
United Kingdom
Houghton Regis, Dunstable
LU5 5BJ
United Kingdom
Beccles Road, Bradwell
Great Yarmouth
NR31 8HB
United Kingdom
Luton
LU1 2QR
United Kingdom
Oldham
OL1 1BE
United Kingdom
Workington
CA14 4DX
United Kingdom
Blaydon-on-Tyne
NE21 5PU
United Kingdom
Gateshead
NE8 1LU
United Kingdom
Newcastle upon Tyne
NE3 4AA
United Kingdom
Birmingham
B42 1TG
United Kingdom
Ipswich
IP2 9TH
United Kingdom
Leamington Spa
CV32 5NS
United Kingdom
Shirebrook, Mansfield
NG20 8AJ
United Kingdom
Grantham
NG31 6DE
United Kingdom
Bolsover, Chesterfield
S44 6PN
United Kingdom
Lincoln
LN5 7RL
United Kingdom
Lincolnshire
NG12 5AA
United Kingdom
Nottingham
NG1 1HW
United Kingdom
Sleaford
NG34 7RL
United Kingdom
Truro
TR1 3HD
United Kingdom
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
Ipswich
IP4 1QJ
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | https://www.birmingham.ac.uk/ |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the study CI, Zehra Yonel, z.yonel@bham.ac.uk. Anonymised data only. The data will be available 24 months after study completion and will be available to access for up to 5 years by people outside the original research group. In order to access data, a data access request form will need to be completed, outlining a brief overview of the intended use of the data and completion of all other elements of that form. The form will be made available on request to the study CI. Any future analyses will need to acknowledge the CI of the current project and the original research team. Depending on intended use and project needs (as outlined on the data access form), it is likely only the specific data requested will be shared rather than the entire dataset. There is likely to be an administrative cost required to prepare and provide access to the data requested. |
Editorial Notes
09/05/2025: Study's existence confirmed by the NIHR.
