Why are we doing this research study?
This research study aims to evaluate how an oral cooling spray, currently a commercial
dietary supplement, impacts symptoms associated with burning mouth syndrome (BMS). This
study will examine symptoms, frequency, and severity, along with other related side
effects of BMS on food intake, enjoyment, and quality of life.
What are some of the important aspects of this research study that I should be aware of?
Timeframe: 2 weeks intervention
Use the oral cooling spray; "Dr.B's Elixir" as directed
Participants will report symptoms and other related impacts of BMS on a weekly online
survey
Optional: complete a phone interview at the end of the 2-weeks intervention period
(~30-60 minutes)
Optional: provide saliva samples (2 collections)
Compensation: No monetary compensation is provided
Direct benefit to research participants: Participants may experience changes in symptoms
commonly experienced by BMS, but this is not guaranteed.
Who can participate in this research study?
We expect to enroll 30-50 individuals.
The eligibility criteria are:
At least 18 years old
Having been diagnosed with burning mouth syndrome or suffer from chronic oral burn
without any identifiable causative lesion
No tongue or cheek piercings
No history of cancer
No recent or scheduled dental treatment
No history of gum disease
No aversions to mint or hop extracts
The exclusion criteria are:
Have recently undergone dental treatment in the last 3 months or have plans to undergo
dental treatment (e.g., fillings, crowns, root canals, extractions, or other dental
procedures) in the coming month.
Have started any new treatments for BMS in the last 3 months or have plans to start new
treatments in the coming month.
What will I be asked to do, and how much time will it take?
The study will take place remotely in the comfort of your own home or residence. The
study takes place over two weeks. Over the two weeks, you will use the oral spray 3 times
per day with 5 sprays directly into your mouth on a single application and you can use up
to 5 additional sprays as needed during each application. You will be completing an
online questionnaire each week about symptoms related to BMS. This questionnaire is
anticipated to take 5-10 minutes to complete. At the end of the 2nd week, participants
have the option of participating in a phone interview which is anticipated to take
approximately 30-60 minutes.
In total this is roughly an hour and a half if you participate in the entire study
including the optional phone interview.
Optional: Phone interview
Participants have the option of participating in a phone interview - approximately 30-60
minutes at the end of the 2-weeks intervention period.
Optional: Salivary samples
Participants have the option to provide two salivary samples. The purpose of collecting
saliva samples is to determine if the oral spray impacts the saliva composition compared
to before its use. One sample will be collected before the oral cooling spray and one at
the end of the two weeks. Then we will be doing shotgun metagenomics to analyze the total
DNA content of the microbial community in the saliva samples. With this information, we
can explore the oral microbiome which may be related to symptoms, taste, and flavor
systems. For example, BMS has been associated with prevalent levels of "streptococcus",
and it is expected that this oral spray may impact the levels of oral streptococcus.
Participants indicating consent to provide saliva samples will have saliva kits mailed
along with the oral spray. After the end of the study, participants will drop the package
in the mail. Return packaging and postage will be included. Participants will mail back
the saliva kits with the pre-paid postage.
