RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM

University of Manitoba Bannatyne Campus Research Ethics Board

Research Ethics Board # HS25411
Online Consent Disclosure Form
Principal Investigator: Denice Bay, +1-(204)-894-9160
Sponsor: PerioDiagnostics Inc. Peter Taylor, +1 (204)-803-6979

RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM

Title of Study: “Rapid point of care strip test development to detect periodontal gum disease bacterial byproducts in saliva”.

INTRODUCTION

Hello, I am Denice Bay, working for the Department of Medical Microbiology and Infectious
Diseases, in partnership with the University of Manitoba, Canada. We are conducting research on infectious diseases that can be transmitted between humans and animals. This study is being funded by the Research Manitoba Innovation and Proof of Concept, and Mitacs Accelerate grant in partnership with Winnipeg company PerioDiagnostics Inc. I am going to give you information and invite you to be part of this research study. Research studies are voluntary and include only people who choose to take part. Please read this consent form carefully and take your time making your decision. There may be some words that you do not understand. If you have any questions later, you can ask the study doctor, nurses or staff at the health facility. Your participation in this research study is voluntary.

WHAT SHOULD I KNOW ABOUT A RESEARCH STUDY?

• Someone will explain this research study to you.
• Whether or not you take part is up to you.
• You can choose not to take part.
• You can agree to take part and later change your mind.
• Your decision will not be held against you.
• You can ask all the questions you want before you decide.

WHY IS THIS RESEARCH BEING DONE?

This research study is being conducted to design and test the accuracy and ability of a rapid color-changing point-of-care device to screen for periodontal gum disease using participant saliva. Periodontal disease is a progressive gum disease that mainly affects older adults over the age of 45 years, that results in irreversible damage to gum tissue, which causes tooth loss and greater risks of systemic blood and cardiac infections. Periodontal disease is caused by certain bacterial species that release chemicals in saliva and in gum pockets that increase damage to gum tissue over time. The purpose of this study is to collect saliva from older adults >30 years of age to test a device that can rapidly detect the chemicals released by periodontal disease-causing bacteria. Here, study team members will collect 2 mL of saliva to test a newly designed point-of-care device. This device uses two different color-changing dyes that can detect different chemicals (organic acids and sulphur containing chemicals) produced by periodontal disease-causing bacteria. The devices tested in this study are easy to interpret by their change in
color. When a device is wetted with saliva, the dyes in the device will only change color if these bacterial chemicals are present at concentrations associated with periodontal disease-causing bacteria in the saliva.
The saliva collected from each participant in this study will be used to complete two tests:

1. To assess the accuracy of different dyes in the point-of-care device to detect saliva from individuals living with and without periodontal disease

2. To determine all bacterial species DNA from saliva used to test the devices using a technique call 16S rDNA sequencing to ensure periodontal disease-causing bacteria are present when tests change color

No participant human DNA will ever be sequenced in any saliva samples collected for this study; only bacterial DNA, as the techniques used in this study can only detect bacterial ribosomal rDNA. To ensure the devices are accurate, this study will sequence all bacteria, to ensure that the healthy bacteria present in the saliva (99.9%) do not interfere with the device’s function, which aims to examine periodontal disease-causing bacterial chemicals only.

As a benefit to all participants who provide their saliva to this study, they will be able to access the results of the saliva microbiome findings in 1 year’s time after the study is completed. Each participant will be able to see their unique oral microbiome finding on our study website. An oral microbiome analysis provides a snapshot of the types of bacteria in a saliva sample. The unique identifying number in the study pamphlet will help access the online website with this information.

All data collected is anonymous, so it is important to save this Pamphlet and Unique Code if you decide to follow up on your specific results.

THE BENEFITS OF UNDERSTANDING YOUR MICROBIOME

Bacteria in your saliva help digest your food, regulate your immune system, protect against other harmful bacteria that cause disease, and produce vitamins including B vitamins B12, thiamine and riboflavin, and Vitamin K, needed for blood coagulation. This study will give participants a unique and rare view of their personal microbiome that could help them learn more about their own microbiome and change lifestyle habits. A total of 300 participants will participate in this study.

STUDY PROCEDURES

In addition to providing a small sample of saliva by spitting in a collection tube provided by the study team, you will also be asked to complete a questionnaire. This questionnaire is essential for the study to determine the extent to which some beverages and foods are commonly eaten and how some lifestyle habits (such as smoking, vaping, or cannabis use) could adversely interfere with the point-of-care devices. These factors will be included in the study analysis.

This study will be blinded and fully anonymized. Please do not provide your name, address or any personal identifying information to study staff, as it is not required. Questions we ask on the accompanying study questionnaire survey will also be anonymous and will not ask for this information but it will ask for information regarding your oral health and lifestyle practices. Please only use the unique identifying number that is part of the pamphlet and saliva collection kit that you will be given. The pamphlet will explain how to provide your salivary sample and once the study is completed 1 year from now, how to access the study website and your personal microbiome data that will be posted at the end of the study. Half the participants in this study are expected to have periodontal disease at some stage, and half of the samples collected from adults may not.

If you take part in this study, you will be asked to complete the following procedures:
 

1. Provide your saliva by spitting into a collection tube vial and filling it to the fill line, provided by the
sampling team. A total of 2 mL of saliva is needed for this study.

2. Complete and submit the online anonymous questionnaire provided by the sampling team (either by
tablet or on your phone)

Participation in the study only requires one salivary donation and questionnaire survey completion. There will be no follow-up appointments.

The researcher may decide to take you off this study if:

• You are not 30 years of age or older
• You provide only a saliva sample but do not complete the adjoining questionnaire
• If you are here to receive urgent or emergency dental care

You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the study staff first.

ARE THERE ANY RISKS OR DISCOMFORTS?

You will be asked questions about private matters such as your dental history and age, as well as potentially difficult questions about your dietary and lifestyle behaviours, which may be uncomfortable to answer. You may refuse to answer any question you do not feel comfortable answering, and we will interview you in a private setting.

If you take part in this study, you will be asked to give a saliva sample. Saliva donation is not painful but might be challenging to provide if your mouth is dry. Please take a few moments to produce saliva by not swallowing for 1-2 min then spit into the collection tube provided.

ARE THERE ANY BENEFITS IF I PARTICIPATE?

There is no direct benefit to you for participating in this study other than eventually learning more about your own personal microbiome once the study is completed. This information is intended for personal interest in learning more about your oral microbiome which is unique for each person. Information obtained from this study will increase our understanding of periodontal diseases and the risks that exist for a future periodontal disease detection. This information may assist adults identify if they have periodontal diseases signs earlier to prevent gum damage.

WHAT OTHER CHOICES DO I HAVE IF I CHOOSE NOT TO PARTICIPATE?

Your alternative to participating in this study is to not participate. If you decide not to participate in the study, it will not affect the care you receive at this dental clinic today or any time in the future.

HOW WILL INFORMATION ABOUT ME AND MY PARTICIPATION BE KEPT CONFIDENTIAL?

This study is designed to be anonymous and use a unique identifying number to link the saliva collected to the questionnaire responses only. As there will be no names or personal identifying information collected for this study the risks of loss of privacy are very low. The study researchers will do their best to make sure that your private information shared by questionnaires is kept confidential. Information about you will be handled as confidentially as possible, but participating in research may involve a loss of privacy and the potential for a breach in confidentiality. Study data will be physically and electronically secured. As with any use of electronic means to store data, there is a risk of breach of data security.

HOW INFORMATION ABOUT YOU WILL BE STORED:

All your records related to this study are anonymous and will be linked to any general health records. All
identifiable information about you will be replaced with a code. A list linking the code and your questionnaire data will be kept separate from the research data.

PEOPLE AND AGENCIES THAT WILL HAVE ACCESS TO YOUR INFORMATION:

The research team, authorized University of Manitoba personnel, and the study sponsor, may have access to study data and records to monitor the study. Research records provided to authorized, non-University of Manitoba personnel will not contain identifiable information about you. Publications and/or presentations or website with individual microbiome information that result from this study will not identify you by name. In the future, data and specimens collected for this study may be shared with other researchers for other studies that are unknown at this time. Any data shared with other researchers will not include your name or other personal identifying information.

USE OF DATA AND SPECIMENS FOR FUTURE RESEARCH

The researchers intend to keep the research data, specimens, and records in a repository indefinitely. Other researchers will have access to the data for future research.

WILL I BE PAID FOR MY PARTICIPATION?

You will not be paid for your participation in this research study.

WHAT OTHER THINGS SHOULD I CONSIDER BEFORE PARTICIPATION?

Taking part in this study is your choice. You can choose whether or not you want to participate. Whatever decision you make, there will be no penalty to you and you will not lose any of your regular benefits.

• You have a right to have all of your questions answered before deciding whether to take part.
• Your decision will not affect the medical care you receive.
• If you decide to take part, you can leave the study at any time.

Any saliva specimens obtained for the purposes of this study will become the property of the University of
Manitoba. Once you provide the specimens you will not have access to them. The University may share your specimens in the future with other researchers or outside institutions. Information that identifies you will not be shared with anyone outside of this dental clinic. The specimens will be used for research and such use may result in inventions or discoveries that could become the basis for new products or diagnostic or therapeutic agents. In some instances, these inventions and discoveries may be of potential commercial value and may be patented and licensed by the University. You will not receive any money or other benefits derived from any commercial or other products that may be developed from use of the specimens.

WHO CAN I CONTACT IF I HAVE QUESTIONS ABOUT THIS STUDY?

The research team:

If you have any questions, you may ask them now or later, even after you participated in the study. If you
wish to ask questions later or provide feedback, you may contact the following:

Dr. Denice Bay, who is the principle investigator of this study at the University of Manitoba. She lives in
Winnipeg MB, and can be reached by

email: denice.bay@umanitoba.ca and cell phone at: (204)-894-9160.

WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?

• You can choose whether or not you want to be in this study, and you may withdraw your consent and
discontinue participation at any time.
• Whatever decision you make, there will be no penalty to you, and no loss of benefits to which you were
otherwise entitled.
• You may refuse to answer any questions that you do not want to answer, however, by doing so you will
be unable to remain in the study.

You will be given a copy of this information to keep for your records.

HOW DO I INDICATE MY AGREEMENT TO PARTICIPATE?

Check one of the following boxes for each question and submit once completed: