Westmead Oral Health Database and Biobank Establishment a Multidisciplinary Oral Health Database and Biobank at Westmead Centre for Oral Health by Faculty of Dentistry, University of Sydney Funded by Bela Schwartz Foundation Sydney University Deputy Vice-Chancellor Research (DVCR) Funding Faculty of Dentistry Research Committee Funding Objective The Primary objective of this project is to strengthen the research output of the Faculty of Dentistry through establishment of a resource of clinical data and biological samples to facilitate research into important aspects of oral health and the development of evidencebased clinical guidelines. Progress ACTIVITY STATUS COMMENTS Development of Multidisciplinary Survey Form Completed Ethical approval of large questionnaire Completed Pilot testing of Multidisciplinary Survey form-initial Completed Survey tested with staff, students & oral medicine patients Pilot testing of Multidisciplinary Survey form-student use Completed Survey implemented in integrated clinics S2, 2014 Database secure storage-pilot phase (local storage) Completed Removable Storage and back-up media – secured at Westmead Database secure storage-University secure network Completed Addressing patient confidentiality with use of University servers, ethical approval granted Electronic application- data collection Completed File Maker application in Android devices for efficient data collection, ethical approval granted Pilot testing-electronic application In progress Implemented in integrated clinics with the assistance from DMD3 students Ethical approval-Biobank sample collection In progress To obtain approval for sample collection in Westmead and SDH Protocol preparation- sample collection In progress Collect, preserve and store the specimens in optimal conditions for future research Preparation of sample inventory In progress Preparation of data and sample access policies In progress Store the information of the samples stored in biobank which will be linked to the primary database Applications for the access of data and samples for ethically approved research will be reviewed by an independent committee Page 1 of 5 Westmead Oral Health Database and Biobank Preparation of ethically defensible plan In progress Arrangement of facilities, equipment & consumables for biobank In progress Organize coordinators and staff for sample collection In progress This will provide the guidelines for disclosure of information for the participants Equipment necessary for sample collection, preservation & storage (DVCR and Research committee Funding) A postdoctoral fellow and Two clinical research associates will join the project in 2015 (DVCR Funding) Discipline surveys linked to the Oral Health Database ACTIVITY STATUS COMMENTS Discipline survey: Orofacial Pain comprehensive telephone survey; small sample Completed 105 Subjects; analysis focused on pain impact Discipline survey: Orofacial Pain short telephone survey; large sample In progress 20,000 subjects sampled; analysis underway Discipline survey: Caries management system survey, comprehensive survey in 22 practices Completed Discipline survey: Survey on children with facial swellings of odontogenic origin Completed Discipline survey: Survey on infants with feeding difficulties due to ankyloglossia Completed 415 subjects included and followed up; analysis focused on impact of nonsurgical prevention on DMFS increment 240 children included; addressed characteristics, aetiology and management of facial swellings caused by odontogenic infections in the paediatric population 89 children included; addressed presentation and management of infants with feeding difficulties due to ankyloglossia Strategic plan Year 2015 & Year 2016 1. Oral Health Database DMD students will get involved in the data collection process in integrated clinics as a part of the Research Unit of Study. DMD student research projects will be started to commence the use of data available in the oral health database. Data collection will be started in the other specialized clinics at Westmead Centre for Oral Health. Ten Samsung android tablets have been ordered to be used in data collection. 2. Biobank Ethics application for sample collection at Westmead Centre for Oral Health and Sydney Dental Hospital is being prepared and the application will be submitted in June 2015. This Page 2 of 5 Westmead Oral Health Database and Biobank application will include data and sample access policies and ethically defensible plan for information disclosure. Protocols for collection, preservation and storage of samples (blood, dental plaque, buccal swabs, teeth, saliva) are being prepared. A pilot study will be done to evaluate the protocols before actual sample collection starts in the clinics. Currently, facilities for sample preservation and storage are being arranged in Westmead Centre for Oral Health. All the required facilities, equipment and consumables will be ready for sample collection by the end of June 2015. Equipment that has already been ordered are -80C freezers (n=2), 1 door refrigerator, microcentrifuge, cold boxes, cool racks, pipettes, biobanking kit (with USB scanner), label printer, heater circulator for water bath and freezer racks for storage. Quality Control and Management Once both data and sample collection are started, the following will be carried out for quality control and management. Periodic evaluations of protocols and procedures (once in 6 months) Routine surveillance of the process of data and sample collection, sample preservation and storage (once in 6 months during the first year and annually thereafter) Periodic verification of sample locations random sampling (annually) Westmead Biobanking Hub The oral health database and biobank are functioning as a part of Westmead Biobanking Hub. We are closely collaborating with the Hub Biobanking activities to make sure that the Oral health database and biobank comply with the required standards. New Members in the Dentistry team Dr Xiaoyan Zhou, a Post-doctoral researcher will join the project this year. Dr Zhou has obtained her Bachelor of Dental Science and Master of Dental Science from Guanghua School of Stomatology, China. She has obtained her PhD in Oral Microbiology from Faculty of Dentistry, University of Sydney in 2015. With her experience in biological sample collection and laboratory analysis techniques, she will be an asset to the project. Dr Zhou will get actively involved in protocol development and sample collection in the clinics. Two clinical research associates (Dr Kiarash Manshee and Dr Filip Vujovic) have been selected and they will join the project by the end of 2015. They will carry-out individual research projects linked to the oral health database and biobank. These will be the first research projects using this new facility and will serve to demonstrate the potential for new research projects resourced by the biobank. Dr Kiarash Manshee is an orthodontist from Iran who has both clinical and research experience in the field of dentistry. Dr Filip Vujovic has obtained the Doctor of Dental Medicine degree from University of Belgrade in Serbia in 2013 and since then has been working as a dentist in Serbia. Page 3 of 5 Westmead Oral Health Database and Biobank Expected outcome and long term sustainability Once established, collection of patient information and biological samples will be a part of the routine clinical care of all dental patients and other patients throughout Westmead adult and children’s hospitals. Thus, increasing the number of biological samples available along with relevant patient information will improve and enhance opportunities for various research activities and will strengthen the research output of the faculty. Importantly this focus on informatics in the faculty will lead to the development of evidence-based clinical guidelines that will improve the health of the individual and community. Page 4 of 5 Westmead Oral Health Database and Biobank Oral Health Database and Biobank Activities– Flowchart Explanation of the project to the patients and invite to participate No Yes Obtain informed written consent and recruit Clinics DMD students Clinical Research Associate (post doc), DClin Dent Students Allocate database/biobank reference number; record it in patient’s dental records Collection of samples (non-stimulated saliva, buccal swabs, dental plaque, blood, teeth) Data collection Assisted data entry via android tablets Contribution from Individual Projects e.g. Clinical Research Associates trainees Disclosure of the information to the participants when required (Ethically defensible plan) Clearly label and transfer to biobank in optimal conditions Automatic data transfer to the primary database Sample processing Quality check Personal identifiable information separated Store in -800C freezers as aliquots Sample Inventory Coded health related information Biobank Staff Feedback / Report Review Committee Available resources for research activities Application for data and samples for ethically approved research Regular surveillance Regular circulation/ presentation of information on available resources to the researchers Researchers Page 5 of 5