Assessing current clinical concepts in dental practice v2.0, IRAS 297799
This Informed Consent Form has two parts:
Patient Information Sheet (to share information about the research with you)
Consent Form (for signatures if you agree to take part)
Principal Investigator: Colin Campbell Organisation: The Campbell Clinic Proposal: To conduct research regarding current clinical concepts in dental practice.
The Campbell Clinic are developing a number of studies aimed at assessing current clinical practice in dentistry.
We would like to invite you to take part in these studies by giving consent for The Campbell Clinic to store anonymised data acquired as part of your routine treatment. This data will be used for research purposes. This information sheet gives you more information about data storage and use to help you decide whether to take part. You have been sent this form to read in advance of your next appointment, when a member of the team will go through the consent form with you and answer any questions you may have. Please feel free to discuss this with others and remember you are not obliged to participate; this will not affect your care. If you have further questions, you can contact us on: 0115 9823913 or email info@campbell-clinic.co.uk
Section 1: What is involved
Purpose of the studies
To investigate current best practice in implant dentistry and other aspects of dentistry at The Campbell Clinic. Studies will look at different stages of implant treatment, including: the techniques used in implant surgery, implant maintenance and hygiene, short term and long- term outcomes, and patient satisfaction. Other dentistry treatment provided at the Campbell Clinic, such as complex extractions, and any treatment involving conscious sedation may also be studied. This work will help us to continuously improve the service we deliver, understand the needs and expectations of our patients, and provide evidence to support clinical and patient treatment decisions.
Participant selection
We are inviting all adults who attend The Campbell Clinic to participate in collection and storage of data.
Voluntary Participation
Your participation in this project is entirely voluntary. Your choice of treatment remains a decision made by you, and any clinical guidance offered is not influenced by these studies. Whether you choose to participate or not, the quality of treatment you receive at the clinic will not be affected. You may withdraw from the project at any time, and you do not need to give a reason for doing so. However, once a study which uses your anonymised data has been written up for publication, you will not be able to withdraw your consent for us to use your data for that particular study but may still withdraw consent for future uses of your anonymised data.
Procedures and Protocol
In the practice, we will see you for routine appointments to review your care and ensure progress is as normal. This is standard procedure. We may spend just a few minutes of additional time at these appointments to collect relevant data regarding your treatment. We may ask you to complete a short questionnaire regarding your treatment.
Study duration/ Long term follow-up
Data will be collected during your routine appointments to assess your treatment progression. You will not need to make any additional visits to the practice. Please refer to your overall treatment consent documentation for full details of your treatment.
Data Storage and Analysis
Data will be gathered from clinical notes, anonymised, and stored in a secure database on a server that is separate to clinical records. This data WILL NOT involve the use of personal or identifiable data. Gender and year of birth will be stored, as well as relevant information from your medical history. Studies will involve pooling and analysing data from groups of patients to make sure there is no risk of re-identification. This secure database, established in 2016, will be used for research purposes for a minimum of a further 5 years (next review due 2026).
Section 2: Additional Information:
Confidentiality
The information that we collect will be kept confidential. Information collected from you will be available to the practice research team, but we will not share your details with anyone outside of the practice. Any information stored and used by the research team will be anonymised (your name and any other identifiable details will be removed) and kept securely. We may choose to share anonymised information with others outside this practice to support continued development of best practice in dentistry.
Sharing the Results & Research transparency
We plan to share study findings through publications and presentations for other health professionals & researchers to learn from this work. However confidential information will not be shared – all data will be anonymous. You can see an up-to-date list of studies that use information derived from the database on our website. All publications will also be listed on our website www.campbell- clinic.co.uk/research, and accessible via web links or on request to the practice, and we would be happy to discuss and explain any findings with you.
Right to Refuse or Withdraw
It is up to you to decide whether or not to take part in this project. If you do decide to take part you may stop participating at any time you wish, and you do not need to give us a reason for this. We would then stop collecting your data for study purposes, although would continue to store and use data collected up to your withdrawal unless you request us not to. Withdrawing from the project will not affect your treatment, which is our priority.
Benefits
Your participation will help us evaluate the service we provide our patients and help us to maintain the excellent standard of care we offer.
Risks
This study does not involve any additional treatment over and above your routine care. Please refer to your patient information letter to remind you of the risks involved in your treatment. Please see the ‘Confidentiality’ section which discusses appropriate use and storage of confidential information.
Who to contact for further information
If you have any questions or concerns you may ask them at any time. Contact us on 0115 9823913 or email info@campbell-clinic.co.uk.
Complaints
If you wish to complain about any aspect of the studies, then please address your complaints to the Practice Manager at The Campbell Clinic.
Section 3: GDPR Research Transparency Statement
The Campbell Clinic is the sponsor of the research arising from the Research Database based in the UK. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this database. This means that we are responsible for looking after your information and using it properly. The Campbell Clinic research database will keep identifiable (pseudo- anonymised) information about you for a minimum of five years.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw your research consent, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible.
The Campbell Clinic will collect information from you and your medical records for this research database in accordance with our database management protocol. Our legal basis for processing your data is ‘legitimate interests’, and we will still ask for your consent to meet the common law duty of confidentiality.
The Campbell Clinic will use your name and contact details to contact you about the research database, to ask if you are willing to consent for your data to be stored, to make sure that relevant information about the database is recorded for your care, and to oversee the quality of the database. Individuals from The Campbell Clinic and regulatory organisations may look at your medical and research records to check the accuracy of the research. The people in The Campbell Clinic who will have access to information that identifies you will be people who need to contact you as part of your routine care, members of the research team who collect your data, or those who audit the data collection process. When the research team analyse the data, they will not be able to identify you and will not be able to find out your name or contact details.
This research database was approved by a Research Ethics Committee in 2016, and this approval was renewed in 2021 for a minimum of a further five years and is subject to an annual review process.
You can find out more about how we use your information at http://www.campbell-clinic.co.uk/research-nottingham.php or by contacting us at info@campbell-clinic.co.uk ; tel. 0115 9823913. The Data Controller is Colin Campbell, and the Data Protection Officer is Hayley Brown.
If you think your data has been misused or stored insecurely you have a right to lodge a complaint with the Information Commissioner’s Office.
THE CAMPBELL CLINIC STUDY CONSENT FORM
Version…………2………………………….. Date…………2.6.2021……..
Title of project: Assessing current clinical concepts in dental practice v2.0. Primary Investigator: Colin Campbell Contact details: 0115 9823913
No.
Statement
Please Initial
1
I confirm that I have read and understand the participant information sheet dated 2.6.21 version 5.0 for these studies.
2
I have been given the opportunity to ask questions and these have been answered to my satisfaction.
3
I understand my participation is voluntary and I can withdraw at any time without giving reason and without affecting my treatment.
4
I have been informed of and understand the purposes of the studies.
5
I understand that my patient notes may be looked at by researchers at The Campbell Clinic. I give permission for these individuals to have access to my records. Procedures for confidentiality have been explained to me.
6
I understand that my anonymised data may be used in future reports, publications, articles, or presentations by The Campbell Clinic.
7
I understand that any information which could potentially identify me will not be used in published material.
8
I understand that information collected about me could be used to support other future studies and may be shared anonymously with other researchers outside of The Campbell Clinic.
9
I agree to participate in these studies as outlined to me in the Patient Information Sheet.
This proposal has been reviewed by a Research Ethics Committee
Note – this consent form is available online for information only, research consent will be discussed in person at one of your appointments.
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I was first introduced to the Campbell Clinic Ethos around 2018. My wife need help with a the remains of the roots of a tooth. Going with her, as support, cemented my view of how much “love” went into their work!! I subsequently switched Dentists to the CC. I subsequently had £35k’s worth of work on my mouth which has been the best ever “investment” of my life. I have never felt so reassured by any other organisation, in my life. The CC is the exact model of how the future of healthcare should be. I have never felt so involved in my own treatment !!! Thank you CC.
Fantastic experience at the Campbell clinic today, as always. From the moment I arrived, the reception staff were excellent, they always make me a coffee and are super friendly. Never thought I’d say “I'm happy to go to the dentist” Alex has changed my view on dentists, he’s the best.
Had a fantastic experience at the Campbell clinic. I was offered a drink on arrival which eased a twenty minute delay. But once treatment started, what would happen next and how it might affect me was fully explained to me. The team working on my implant couldn’t be more supportive. I was expecting the experience to be painful but I hardly felt anything. I was given a package with pain killers and cooling packs to help with any swelling but I’ve not had much swelling. I’m very pleased with the treatment I received and I hope the following stages go as smoothly as my Campbell Clinic visit.
I was recently referred to The Campbell Clinic by my NHS dentist for some specialist treatment. I am not a great patient and definitely feel anxious. Nilesh completed my treatment, he was calming and reassuring. Very pleased with the outcome.
Today I had the pleasure of visiting the Campbell Clinic for an initial consultation to discuss teeth restoration options with who I can only say were an Incredible team. I was greeted by Ely a Clinical Nurse who started the consultation talking me through the process and taking detailed photographs of my teeth. It was then time to meet the Dental Surgeon Dominic Smithers who got to know me and my history before carrying out a through examination and discussing potential options available to address my current dental issues. This guy really knows his stuff instilling me with great confidence that they're are options available to me my needs. Before leaving the clinic i met back up with Ely who took a full scan of my mouth and it current state of play to allow the team to deliver me a fully detailed dental plan. Many thanks to the whole team 🙌
The level of care and professionalism is phenomenal. Friendly helpful reception staff, incredible patient interaction from my dentist(s) and nurses. My implant treatment has been explained carefully at every step and I’ve always felt comfortable and informed. Best practice I’ve ever been to.
Never thought I’d say this… but I actually enjoy going to the dentist!Meg (hygienist) was great today and Shaun’s brilliant too. I think they actually care about my teeth more than me! That much so I’ve upgraded to the higher plan and added my son on too,Thanks for going a great job,Ross
Always 5 star treatment from The Campbell Clinic. I’ve been a patient since 2016 after needing emergency implant surgery. They have always made what was quite a traumatic process for me feel so calm, professional and have put me at ease. I’ve recently been back to have more work and it has been the same great experience. Special thanks to Andy Legg who is so passionate and professional in this field, thoroughly recommend.
Welcoming, friendly and assuring professionalism from everyone I encountered in the practice. The expertise under this roof is simply incredible, words could not possibly do them justice. I would highly recommend for anyone, of any age, requiring any dental treatment.
Amazing clinic, experienced, top class clinicians, nurses and supporting staff. The facilites are superb, organisation on the high level, purpose built clinic is breath-taking. As a candidate on an implant course I used their facilities to do the surgeries on two occasions and can confidently say this is one of the best clinics I have seen in my 20 years as a dentist in the UK. Prospective and current patients may be reassured they are in the very skilled and capable hands of this top notch team. Best wishes.
Just had the best hygienist experience! I was told this would be amazing by someone else, so expectation was high. Megan, hygienist and dental nurse Anna were great. Lots of helpful information, and a super shine clean. Best ever! Thank you. Can’t wait to come back in Spring.
Very welcoming in reception…with offers of a drink. Saw Vicky who I talked previously to on the telephone who discussed various treatment options with very confident knowledge and was very friendly and put me at instant ease. Then was seen by Dom the dentist who again put me at ease which was welcomed by me who had not long had a bad experience…the dental assistant Ellie then took me for a scan…and again was lovely. I cannot fault anything about today’s experience. It was evident that the whole practice works as a team with good communication. Many thanks!
I would like to express my sincere thanks to Mr Nilesh Dayaram and his assistant for saving my complicated tooth and looking after me so well in an informed, professional and pain free manner. I felt safe while the procedure was carried out. And to have the time to ask questions before and after the procedure was reassuring. I fully recommend Campbell Clinic.
A superb service. My tooth extraction was quick and painless and far less traumatic than I had anticipated. Beatriz Sanchez is a highly skilled professional who also has the ability to make patients feel at ease. Since the extraction, pain has been minimal and I have not had to use any pain relief at all.
I had an appointment this evening with the dental hygienist. On arrival I was greeted warmly by Janice who made me feel welcome and relaxed. Megan the hygienist saw to me promptly and I was shown to the treatment room where I was introduced to her assistant Anna.My teeth needed a lot of work doing and I was extremely impressed with the professionalism and the manner everything was handled. I was in treatment for a whole hour and not once did I feel any discomfort which was testament to Megan’s experienced and masterful dexterous hands and Anna’s cohesive assist!I would highly recommend anyone seeking dental work to try The Campbell Clinic. I’m glad I chose to come here and as a repeat customer I’m confident that I’m getting the best care for my teeth here and will continue to do see in future.
I had a lovely experience at the Campbell Clinic .The reception area is light and airy with a calm atmosphere.The staff are lovely and very helpful.The chair in the treatment room was something else , it is so comfortable!I am very impressed.
Great experience, was referred to Andy Legg for removal of implant screw . Lovely welcome from reception and team , found the experience very calm , friendly and caring from all staff , beautiful bright clean and stylish practice.
I am very happy with the treatment I have received at the Campbell Clinic by all staff. To date I have had root canal treatment on a bottom molar and later, the tooth prepared for a crown to be fitted. Nilesh (my dentist) has been extremely professional, kind and friendly. He has explained all the steps of my treatment very clearly and I have total confidence in him.
The Campbell Clinic are an extremely professional dental practice that provide the very best treatment and customer care. I would like to, in particular, thank Shaun Sellars for all his hard work, care and brilliance in addition to Jess and Megan Knowles for theirs. A special mention also to Sharon and Daniella as well. I would highly recommend this business having been a customer for nearly a decade.
I was referred to the Campbell Clinic to undergo a gum graft procedure, and I was treated by Rajan. The treatment I received was excellent, the dentist was very thorough at explaining everything clearly, and I was made to feel very comfortable and reassured.The practice has a really welcoming atmosphere and the staff are really friendly. I’ve felt really well looked after here and feel I can really trust the care I have received. I can confidently recommend this practice to friends and family. Thank you
Very welcoming in reception…with offers of a drink. Saw Vicky who I talked previously to on the telephone who discussed various treatment options with very confident knowledge and was very friendly and put me at instant ease. Then was seen by Dom the dentist who again put me at ease which was welcomed by me who had not long had a bad experience…the dental assistant Ellie then took me for a scan…and again was lovely. I cannot fault anything about today’s experience. It was evident that the whole practice works as a team with good communication. Many thanks!
I had a lovely experience at the Campbell Clinic .The reception area is light and airy with a calm atmosphere.The staff are lovely and very helpful.The chair in the treatment room was something else , it is so comfortable!I am very impressed.
Excellent hygiene visit today. Both the hygienist and nurse showed compassion and care during my appointment. The aftercare was very informative and I was given the tools to maintain the great clean that I received. Thank you
Brilliant start to end service.Had an appointment to see Matt Smart who was wonderful. Explained in detail of the procedure and options available.No pressure to make a decision on tbe treatment there and then. I left fully informed and confident I'd make the right decision.Would 100% recommend this practice
Very friendly and welcoming staff. I have always had regular dental check ups since a child (over 50 years), and this was the most thorough, detailed dental check up ever. So detailed, very knowledgeable and friendly team, explained lots about my teeth, really very positive first experience. 10/10
A superb service. My tooth extraction was quick and painless and far less traumatic than I had anticipated. Beatriz Sanchez is a highly skilled professional who also has the ability to make patients feel at ease. Since the extraction, pain has been minimal and I have not had to use any pain relief at all.
I have been going here for some months for treatment and it has been excellent in every aspect. Always spotlessly clean with wonderful friendly and helpful staff.My dental surgeon Andy Legg has been superb, always putting me at ease and is incredibly skilled and knowledgeable. Nurse Lauren is brilliant too - kind, helpful and also very skilled.All in all a very positive experience and highly recommended.
