An Early Phase 1 interventional study of Oral cooling spray in Burning Mouth Syndrome, sponsored by University of Massachusetts, Amherst. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by University of Massachusetts, Amherst · Early Phase 1, Interventional, and Supportive care
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.
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.
47 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 38 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →University of Massachusetts, Amherst is the lead sponsor of 48 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Oral spray
Dietary Supplement: Oral cooling spray
Use oral spray 3 times per day for 2 weeks
Improved symptoms
Frequency, severity, and duration of oral burn between regular treatment decreases after 2 weeks of using the oral spray
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
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University of Massachusetts, Amherst