Oral cooling spray to relieve burning mouth symptoms
Official title: Burning Mouth Syndrome: Symptoms and Management
Run by University of Massachusetts, Amherst · NCT07016555 · Data updated 2026-11-12
Over two weeks, adults with burning mouth syndrome will try an over-the-counter oral cooling spray (Dr.B's Elixir) to see if it reduces burning, decreases symptom frequency, and improves eating enjoyment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Massachusetts, Amherst Academic / other |
| Locations | 1 site (Amherst, Massachusetts) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | August 31, 2025 |
| Study ends | December 15, 2025 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT07016555 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) in the United States with a diagnosis or suspected diagnosis of burning mouth syndrome or chronic oral burning without an identifiable lesion, who have no recent dental treatment, no tongue or cheek piercings, no history of cancer or gum disease, and no aversion to mint or hop extracts.
✕Probably not a fit
People whose oral burning has an identifiable cause (e.g., lesion), who recently had or plan dental procedures, who recently started new BMS treatments, or who are allergic/averse to the spray ingredients may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase interventional study will enroll about 30–50 adults with diagnosed or suspected burning mouth syndrome and ask them to use an oral cooling spray as directed for two weeks. Participants will complete weekly online surveys about symptom severity, frequency, effects on eating and enjoyment, and quality of life. Optional components include a 30–60 minute phone interview at the end of the intervention and two saliva sample collections. The study is conducted through the University of Massachusetts Amherst and does not provide monetary compensation.
Why it matters
Potential benefit: If successful, the spray could reduce oral burning sensations and improve eating comfort and quality of life for people with BMS.
How similar studies have gone: Use of topical cooling or menthol-containing agents for oral pain has limited and mostly preliminary clinical evidence, so this specific oral cooling spray approach is largely novel for BMS.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * No recent or scheduled dental treatment * No history of gum disease * No aversions to mint or hop extracts Exclusion Criteria: * 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.
Where it's running
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UMass Amherst
Amherst, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Alissa Nolden, PhD
- Email: anolden@umass.edu
- Phone: 413-577-0113
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.