The following are answers to frequently asked questions. For full information, please see the Information Sheets.

Why have I been invited to take part?

You have been invited to take part as you have a diagnosis of Alzheimer’s disease or MCI.  We are hoping to recruit approximately 50 people with early-stage Alzheimer’s Disease or MCI, together with their chosen project partner (e.g. a friend, relative or carer) to take part in this feasibility study.

To help with this study it is important that every person who takes part in the study has a project partner who must attend their first appointment with them and provide support, if necessary.  The project partner does not necessarily need to attend subsequent appointments.  If you decide to take part then your project partner should be someone you know well, such as an adult family member or close friend. You may choose to have more than one project partner.

Do I have to take part?

No, it is up to you to decide if you want to join the study. We will describe the study and go through this information sheet with you. If you agree to take part, we will ask you to sign a consent form. You are free to withdraw from the study at any time, without giving a reason. This will not affect the treatment you receive for your memory loss in any way. We will also ask your project partner if they are happy to take part in the study.

What are the possible benefits of taking part?

If you take part in the study you will receive an electric tooth brush, tooth paste and interdental brushes together with a leaflet about how to keep your teeth clean.

• If you are in Group 1 you will receive dental treatment aimed to improve your dental health and oral hygiene. All dental care provided by study dentists will be free of charge.
• If you are in Group 2 you can ask to have the same dental treatment that people in group 1 received, at the end of the study. This will be free of charge. If you are in Group 2 and decide to attend your own dentist during the main study period, they will charge you as usual.

Both groups will also receive three or four cognitive assessments to determine how well you are remembering things; this will help you to monitor your memory loss.

We cannot promise that keeping your mouth clean will help your memory loss, but the information we get from this study will help us design a bigger study to test if improving oral hygiene can slow the onset and progression of memory loss.

What are the possible disadvantages and risks of taking part?

The dental treatment you will be given will be routine.  Every effort will be made to alleviate any pain or discomfort with a dental cause. Risks of treatment will be no greater than those encountered if you were to attend your own dentist.

When necessary, you will be given an injection to make your mouth numb before treatment to minimise any discomfort.  A gel will be applied to your gum prior to the injection to minimise any discomfort from the injection itself.

You may be asked to have an X-ray to determine what treatment you need. This is a normal requirement before dental treatment, and the dose of radiation that you receive from the X-ray is low.  The X-rays will enable the dentist to spot problems and signs of disease that may not be visible on the surface of your teeth and gums when the dentist examines them. The X-rays are necessary to reach a diagnosis and formulate the best treatment plan for you.

If it is thought to be necessary, you may also be asked to take a short course of antibiotics, and it is possible that you could be allergic to the antibiotic prescribed. The dentist will take a full medical history to make sure they are not prescribing something that you are known to be allergic to.  They will also provide you and your project partner advice regarding what to do and who to contact if you feel unwell after taking the antibiotics. As with all antibiotics, there is a risk of gut problems which can cause symptoms whilst taking a course of antibiotics or up to 2 months afterwards.  Noticeable symptoms may be changed bowel movements, diarrhoea, fever, loss of appetite, nausea, abdominal pain or tenderness.  This can be caused by the bacteria Clostridium difficile and associated disease and if you notice any of these changes you should arrange a consultation with your general medical practitioner (doctor).

When blood is taken there will be a sharp scratch from the needle, but this should not last long and is no different to giving blood for a blood test.

Up to £20 per visit will be available to help towards covering the cost of transport, please ask us.

What if something goes wrong?

If you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, please contact a member of the research team (details at the bottom of this information sheet) or the Patient Support and Complaints Team (at UHBW) on 0117 342 1050, or by email: PSCT@uhbw.nhs.uk.

What will happen if I don’t want to carry on with the study?

You can withdraw from the study at any time without giving a reason; this will not affect the health care that you receive now or in the future.

Your anonymised data about your dental health and how well you are able to remember things will be retained for the study unless you ask us to remove it from the study at the time you withdraw. Any of your saliva or blood samples that are unused at the time that you withdraw will be retained for the study unless it is requested that they are destroyed, but it will not be possible to destroy any samples that have already been used up.

Will my taking part in the study be kept confidential?

Yes. Your participation in the study will be treated as confidential, any personally identifiable information will be held and processed under secure conditions by the study team and authorised agents only. If you consent to take part in this study, only your project partner who has enrolled in the study with you, the research team and your dentist (if you have one) will know that you are taking part, the treatment you are receiving and the results of your oral health assessments. Your identity will not be disclosed to any other person, except in the event of a medical emergency or if required by law. However, we will also ask you if we can notify your doctor (‘general practitioner’) of your participation, if you agree they will also know that you are taking part. If you do not want us to tell them you are taking part in the study that is fine, just let us know.

Your anonymised data will be processed electronically to determine the outcome of this study.  You will not be referred to by name in any report or publication (in a scientific journal) of the study. A study monitor whose job it is to check that the study is running correctly may observe the study procedures at one or more study visits.

What will happen to my saliva and blood samples?

Your saliva and blood samples will be frozen and a number (a code) will be given to both your sample and your data by a member of the clinical care team. Only the non-laboratory research staff will know who the samples and data came from. The saliva and blood samples will be used by the laboratory researchers to analyse the human inflammation proteins they contain, these tests are not diagnostic. They will also be used to estimate the number of bacteria and type of bacteria you have in your mouth and blood.  Samples will be stored safely and with your permission, if there is any left over we would like to be able to use it in future studies investigating gum health and memory loss and we will ask for your consent to do this.

Who will have access to my saliva and blood samples?

Only the clinical staff who took the samples and the researchers estimating the amount of bacteria and looking at the human proteins will have access to the samples during the study. If you give your permission for the use of the samples in future research they will be provided to other researchers in anonymised form (so that the researchers do not know who the samples came from, they will not know that the samples are yours). We will keep your signed consent form with these stored samples so that we can show that you are happy for the samples to be used for future research.

How will we use information about you? 

We will need to use information from you for this research project. 

This information will include: your initials, Name, Contact Details, The details of your dentist (and doctor if you give us permission to contact them), Medical history, Your gum health and memory scores, Information about the bacteria in your saliva and the proteins that indicate inflammation in your blood.

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. 

We will keep all information about you safe and secure. 

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
• If you agree to take part in this study, you will have the option to take part in future research using your anonymised data saved from this study. If you agree, your anonymised data will be saved in the University of Bristol’s Research Data Repository.  

Where can you find out more about how your information is used?

You can find out more about how we use your information

• at www.hra.nhs.uk/information-about-patients/
• our leaflet available from our website www.uhbristol.nhs.uk/research-innovation/for-patients-and-public/how-we-use-your-information-(gdpr)/
• by asking one of the research team
• by sending an email to our Data Protection Officer: InformationGovernance@UHBW.nhs.uk
• by ringing us on 0117 34 23701 or 0117 34 23794. (Data Protection Officer).

How have patients and the public been involved with the study?

We have discussed the study with those living with memory loss, who were interested in the study and keen to learn more about the potential links between memory loss and dental disease. We also have a patient advisory group who are helping during the study, providing patient feedback so that we can take this into account while the study is running.

If you would like to take part, or if you would like to ask some questions before deciding contact:

• Miss Nikki Hellin, Bristol Dental School, Bristol Dental Hospital, Lower Maudlin Street, Bristol, BS1 2LY, UK. Email: nikki.hellin@bristol.ac.uk. Tel:  07773 579130.
• Or the Clinical Trials Team at Bristol Dental School, Lower Maudlin Street, Bristol, BS1 2LY. Email: dental-clinical-trials@bristol.ac.uk