Stanford & UCSF researchers need healthy, non-smoking volunteers over the age of 18!
What is the purpose of the research? We hope to learn how saliva shapes the composition of microbial communities in the human mouth. Ultimately, we are interested in developing novel, ecologically-based therapeutics that target the altered oral microbial communities present in individuals with low salivary flow rates due to medication usage, radiation therapy, and certain autoimmune disorders. For more information, please see the Understanding Oral Health and the general Projects pages.
What would be my time commitment? This research study is expected to require a maximum of 36 days of active participation. In total, we are asking volunteers to contribute a maximum of about 29.5 hours.
What will we ask volunteers to do? We will ask volunteers to participate in the home sample collection protocol as well as the clinical sample collection protocol, as detailed below.
1. Home sample collection protocol: engaging the citizen scientist in each of you!
To understand how microbial communities in the mouth vary from place to place and over time, we will ask 59 healthy, non-smoking volunteers to take samples from the front and back surface of each of 12 teeth on a daily basis over the course of 29 consecutive days. We will also ask you to sample saliva and a maximum of 7 oral mucosal surfaces. Home sample collection takes approximately 15-30 minutes each day on average. We ask volunteers to avoid eating, drinking or performing oral hygiene for a two-hour period before sample collection. Volunteers are also asked to collect samples at about the same time each day. Finally, we ask volunteers to make daily entries into an online laboratory notebook.
We will train volunteers on dental anatomy (i.e., “Calibration”), so volunteers are able to identify the sample sites under investigation in this study. We will also provide volunteers with all the soft, sterile foam swabs needed to perform home sample collection. We will ask volunteers to temporarily store samples in their home freezers until samples can be transported, by the volunteer, to the dental clinic at UCSF.
2. Clinical sample collection protocol: collaborating with our clinical team!
We will ask volunteers to attend a 1-1.5 hour appointment at the UCSF School of Dentistry Oral Medicine Clinic once per week over the course of 36 days in order to allow a clinician to collect samples, to measure the salivary flow rate, and to measure dental plaque pH. In addition, we will assess each subject’s understanding of oral dental anatomy at each clinical sample collection appointment by asking our volunteers to take a short, online quiz.
What will we do with the samples we collect? We will extract genomic DNA from each of the samples we collect. We will perform DNA sequencing to identify the composition and relative abundance of the bacteria present in each of the samples. In addition to sequencing the DNA of bacteria, we will use mass spectrometry to identify small molecules that are produced by the bacteria present in a select subset of samples. We will perform statistical tests to evaluate the spatial and temporal variation of bacterial communities within individuals and among individuals sampled in this experiment.
What are the costs of participation? There will be no costs to volunteers for participating in this research study. We will provide volunteers with a parking sticker to cover the cost of parking in the Millbery Union Parking Garage for the duration of each clinical sample collection appointment.
What are the benefits to participants? Participants will receive a no-cost dental examination, a maximum of $245, and the satisfaction of helping advance our understanding of the microbial ecosystem that defines human health! Participants also get the chance to learn about their own microbiome!
How can I find out if I’m eligible to participate? We will ask volunteers to complete a telephone interview (Step 1) and a 2-hour dental examination at the UCSF School of Dentistry (Step 2) before enrolling eligible subjects (Step 3).
What are the eligibility criteria? Individuals should be non-smoking adults over the age of 18 who have not used tobacco products within the preceding 6 months. They should have healthy mouths as defined by a lack of active periodontitis, halitosis, unrestored dental caries or oral mucosal disease.
Exclusion Criteria: Individuals should not be under the care of a physician for any chronic condition requiring treatment, should not be taking any medication other than birth control on a daily basis, should not have used oral, systemic antibiotics or antifungals within the preceding 6-months. Individuals should not have a history of drug abuse or of eating disorders, or of dry mouth.
For a full disclosure of eligibility restrictions, as well as a list of the risks and benefits of study participation: please download the Written Informed Consent Form.
Where can I get more information? For additional information, please contact us by email at HyposalivationStudy@UCSF.edu or by phone at (415)-696-2377.
This not-for-profit research project is funded by a National Institute of Dental and Craniofacial Research grant (R01-DE23113-001) to Dr. David Relman.
For general information about participant rights, contact 1-(866)-680-2906.