Using a smartphone app to track symptoms in burning mouth syndrome patients
Official title: FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population
Run by University of Pennsylvania · NCT05819697 · Data updated 2026-11-12
This study is testing a smartphone app to help people with burning mouth syndrome track their symptoms and saliva changes over 12 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | March 14, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT05819697 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 18 and older who have been diagnosed with burning mouth syndrome for at least three months and have access to a smartphone.
✕Probably not a fit
Patients with cognitive or physical impairments, prior head and neck radiation or chemotherapy, or those on medications that affect the inflammatory system may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to understand the symptoms of burning mouth syndrome (BMS) in real time by utilizing a smartphone app. Participants will complete questionnaires and provide saliva samples during two study visits, while also responding to notifications three times a day for 12 weeks. The study will assess fluctuations in BMS symptoms and evaluate salivary biomarkers to better characterize the condition. The collaboration between Penn Dental Medicine and the Wharton School of Business seeks to enhance data collection and analysis through innovative technology.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of burning mouth syndrome symptoms for patients.
How similar studies have gone: While the use of smartphone apps for symptom tracking is becoming more common, this specific approach to studying burning mouth syndrome is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals aged 18 years and older 2. Willing and able to provide informed consent 3. Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist 4. Willing to submit a saliva sample 5. Have continuous access to a smartphone Exclusion criteria: 1. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment) 2. Prior head and neck radiation and/or chemotherapy 3. Medications that modulate or suppress the inflammatory system
Where it's running
-
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Eugene Ko, DDS — Penn Dental School of Medicine, Center for Clinical and Translational Research
- Study coordinator: Eugene Ko, DDS
- Email: PDMTranslationalMed@dental.upenn.edu
- Phone: 215-573-8177
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
MucoLock™ to relieve mouth pain from stomatitis
This study will test whether using MucoLock™ as a swish-and-spit mouth rinse three times a day for 28 days can reduce burning and pain in adults with oral dysesthesia.
-
Oral cooling spray to relieve burning mouth symptoms
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.
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.