Healthy Saliva Study
Background
It has recently been shown that COVID-19 virus is able to infect cells in the human mouth, including cheek cells. The Valm laboratory is interested in understanding what role these cells play in COVID-19 infection. For this, we will collect saliva from healthy volunteers and and use microscopes to visualize and count these cells in saliva from different healthy volunteers.
Cheek epithelial cell in saliva from a healthy volunteer imaged in the Valm laboratory
Participation
Participation in this study is completely voluntary. If you participate, you will be asked to not perform oral hygiene procedures for 48 hours, this includes brushing or flossing your teeth or using mouthwash. After 48 hours, volunteers will come in to visit the lab to donate saliva. You will be given a tube to spit in for about 30 minutes. You will also be asked to provide a saliva sample for the University at Albany COVID-19 saliva screening program at the time of your visit. The entire process should take about 45 minutes.
Eligibility
In order to participate in this study, you must meet the following eligibility criteria:
1. You must be 18 years old or older
2. You must be fully vaccinated against COVID-19 with one of the US FDA authorized-for-emergency-use vaccines.
3. You must participate in the UAlbany COVID-19 saliva screening program.
4. You must not have taken antibiotics in the 6 months previous to your participation.
5. You must not normally take antibiotics before dental procedures to prevent infectious endocarditis, also known as I.E.
6. You must not have had a confirmed positive COVID-19 diagnosis within 14 days of your visit.
7. You must not have experienced any symptoms of COVID-19 infection within 10 days of your visit. These symptoms are:
1. Fever or chills
2. Cough
3. Shortness of breath
or difficulty breathing
4. Fatigue, muscle or body aches
5. Headache
6. New loss of taste or smell
7. Sore throat
8. Congestion or runny nose
9. Nausea, vomiting or diarrhea
8. You must not have had close contact with someone who has received a confirmed COVID-19 diagnostic test within 10 days of your visit to the lab.
Compensation
You will receive a $75 Amazon gift card for participating in the study at the time that you make your plaque and saliva donations. You will also be given a travel size toothbrush, toothpaste, mouthwash and a bottle of water.
Benefits
There is no direct benefit to you for participating in this study; however, you will be helping advance our knowledge of healthy saliva in the mouth. This could lead to better treatments for COVID-19 infection or other viral infections in the future.
Confidentiality
Your participation in this study will be kept strictly confidential. No identifying characteristics about you such as your name will be associated with your plaque and saliva donation. Instead, it will be assigned a barcode number. The result of your COVID-19 saliva screen sample taken at the time of your plaque and saliva donation will be reported to Dr. Valm; however, only your barcode number will be used to identify you. The screening center will not report any personally identifying information such as your name to Dr. Valm. Because the plaque and saliva samples are anonymous, once you provide these samples to us, they cannot be withdrawn from the study at a later date.
How to enroll or learn more about the study
If you meet the eligibility criteria and would like to participate in the study, please call Dr. Alex Valm at 518-442-4324 to schedule a time to make a saliva donation. You may also call or email Dr. Valm if you have questions about any aspect of the study.
Phone: 518-442-4324
E-mail: avalm@albany.edu
Research at the University Albany involving human participants is carried out under the oversight of the Institutional Review Board (IRB). This research has been reviewed and approved by the IRB. If you have any questions concerning your rights as a research subject or if you wish to report any concerns about the study, you may contact University at Albany Office for Pre-Award and Compliance Services at 1-866-857-5459 or hsconcerns@albany.edu.
If you have questions for Dr. Valm about this study, feel free to use the form below: