Burning Mouth SyndromeEarly Phase 1NCT07016555
Burning Mouth Syndrome: Symptoms and Management
A Early Phase 1 study testing Oral cooling spray in people with Burning Mouth Syndrome, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Oral cooling spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 15 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have buring mouth syndrome or experience oral burn
- Live in the United States
- At least 18 years old
- Having been diagnosed or suspected diagnosis of burning mouth syndrome or suffer from chronic oral burn without any identifiable causative lesion
- No tongue or cheek piercings
- No history of cancer
Show all 9Show fewer
- No recent or scheduled dental treatment
- No history of gum disease
- No aversions to mint or hop extracts
Who cannot join
- Have recently undergone dental treatment in the last three 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Amherst
Amherst, Massachusetts, 01002
About this 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.
Read the detailed description
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.
- Conditions
- Burning Mouth Syndrome
- Being tested
- Oral cooling spray
- Keywords
- Symptom management, burning mouth syndrome, oral spray
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral cooling sprayDietary supplement
Use oral spray 3 times per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral spray | Experimental | Oral spray Receives: Dietary Supplement: Oral cooling spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved symptoms
Frequency, severity, and duration of oral burn between regular treatment decreases after 2 weeks of using the oral spray
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start11 Jun 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alissa Nolden, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016555
- Sponsor's protocol ID
- 6052
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burning Mouth Syndrome: Symptoms and Management
- ClinicalTrials.gov ID
- NCT07016555
- Acronym / sponsor ID
- 6052
- Conditions
- Burning Mouth Syndrome
- Keywords
- Symptom management, burning mouth syndrome, oral spray
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 11 Jun 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral spray | Experimental | Dietary Supplement: Oral cooling sprayOral spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have buring mouth syndrome or experience oral burn
- Live in the United States
- At least 18 years old
- Having been diagnosed or suspected diagnosis of burning mouth syndrome or suffer from chronic oral burn without any identifiable causative lesion
- No tongue or cheek piercings
Key exclusion criteria (2 listed)
- Have recently undergone dental treatment in the last three 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral cooling sprayUse oral spray 3 times per day for 2 weeks | Dietary supplement | Oral spray |
Primary outcome
Improved symptoms
Time frame: 2 weeks
Frequency, severity, and duration of oral burn between regular treatment decreases after 2 weeks of using the oral spray
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral cooling spray in people with Burning Mouth Syndrome, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alissa Nolden, PhD (413-577-0113, anolden@umass.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved symptoms (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.