Burning Mouth SyndromeNCT05819697
Reducing Patient Memory Recall in the Burning Mouth Patient Population
An observational study of Burning Mouth Syndrome, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to learn about burning mouth syndrome symptoms in real time in patients with burning mouth syndrome. The main questions it aims to answer are: (1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at… 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?
- FIRE Trial/Track Your Happiness notifications
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 30 Dec 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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
Study population: The target population will be patients who have been diagnosed with burning mouth syndrome by Oral Medicine specialists.
Who may be able to join
- Individuals aged 18 years and older
- Willing and able to provide informed consent
- Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist
- Willing to submit a saliva sample
- Have continuous access to a smartphone
Who cannot join
- 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)
- Prior head and neck radiation and/or chemotherapy
- Medications that modulate or suppress the inflammatory system
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
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Eugene Ko, DDS
About this study
Official title: FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population
The goal of this study is to learn about burning mouth syndrome symptoms in real time in patients with burning mouth syndrome. The main questions it aims to answer are:
(1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables. With a collaboration between Penn Dental Medicine and Wharton School of Business, our proposal aims to vastly improve the characterization of burning mouth syndrome through the use of a smartphone app and/or text-based notification.
Participants will attend 2 study visits where they will complete questionnaires and provide saliva samples and will respond to notifications/text message prompts on their smart phone 3 times a day for 12 weeks.
Read the detailed description
This is a prospective study with the aims: (1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables.
Participants will attend 2 study visits. Visit 1 of the study will consist of screening during the baseline visit. It will include administration of questionnaires, informed consent, collection of salivary samples, helping to download the app and/or helping to set up the smartphone to receive text notifications, and assisting with the demonstration of taking surveys on smartphones.
Track Your Happiness app, a smartphone and/or text-based notification system to take surveys, will collect data on people's experiences across a random sample of the moments of their lives. Participants will receives notifications 3 times per day at random times, and will be prompted to answer questions related to the burning mouth, to exercise, and a random selection of non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?" Participants will receive these notifications for 12 weeks.
The final study visit (visit 2) will take place 12 weeks after Visit 1. Visit 2 will consist of questionnaires and collection of salivary samples.
- Conditions
- Burning Mouth Syndrome
- Being tested
- FIRE Trial/Track Your Happiness notifications
- Keywords
- burning mouth syndrome, oral pain, burning mouth, chronic intraoral burning sensation
- 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.
FIRE Trial/Track Your Happiness notificationsOther
All participants will receive notifications to their smart phones 3 times a day for 12 weeks. They will be asked questions related to burning mouth, to exercise as well as non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?"
| Study group | Role | What they receive |
|---|---|---|
| FIRE Trial Participants | This study only has one group. All participants will receive the same intervention (smart phone app/texting notifications). Receives: Other: FIRE Trial/Track Your Happiness notifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time
Track Your Happiness app on smartphone and/or text base notification system will collect data in real time on people's experiences across a random sample of the moments of their lives through surveys. Participants will receive a notification on their phone at three random times each day and be prompted to answer questions adapted from the FIRE questionnaire related to burning mouth syndrome symptoms.
Measured: 12 weeks
Secondary outcomes (1)
Salivary Biomarkers
The relationship between salivary biomarkers and burning mouth syndrome (BMS) symptoms.
Measured: Baseline and follow up visit (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start14 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene Ko, DDS, Principal investigator, Penn Dental School of Medicine, Center for Clinical and Translational Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819697
- Sponsor's protocol ID
- 843642
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2023
- Last updated
- 12 Feb 2026
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population
- ClinicalTrials.gov ID
- NCT05819697
- Acronym / sponsor ID
- 843642
- Conditions
- Burning Mouth Syndrome
- Keywords
- burning mouth syndrome, oral pain, burning mouth, chronic intraoral burning sensation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Apr 2023 (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.
The goal of this study is to learn about burning mouth syndrome symptoms in real time in patients with burning mouth syndrome. The main questions it aims to answer are:
(1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables. With a collaboration between Penn Dental Medicine and Wharton School of Business, our proposal aims to vastly improve the characterization of burning mouth syndrome through the use of a smartphone app and/or text-based notification.
Participants will attend 2 study visits where they will complete questionnaires and provide saliva samples and will respond to notifications/text message prompts on their smart phone 3 times a day for 12 weeks.
Detailed description
This is a prospective study with the aims: (1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables.
Participants will attend 2 study visits. Visit 1 of the study will consist of screening during the baseline visit. It will include administration of questionnaires, informed consent, collection of salivary samples, helping to download the app and/or helping to set up the smartphone to receive text notifications, and assisting with the demonstration of taking surveys on smartphones.
Track Your Happiness app, a smartphone and/or text-based notification system to take surveys, will collect data on people's experiences across a random sample of the moments of their lives. Participants will receives notifications 3 times per day at random times, and will be prompted to answer questions related to the burning mouth, to exercise, and a random selection of non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?" Participants will receive these notifications for 12 weeks.
The final study visit (visit 2) will take place 12 weeks after Visit 1. Visit 2 will consist of questionnaires and collection of salivary samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIRE Trial Participants | – | Other: FIRE Trial/Track Your Happiness notificationsThis study only has one group. All participants will receive the same intervention (smart phone app/texting notifications). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be patients who have been diagnosed with burning mouth syndrome by Oral Medicine specialists.
Key inclusion criteria (5 listed)
- Individuals aged 18 years and older
- Willing and able to provide informed consent
- Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist
- Willing to submit a saliva sample
- Have continuous access to a smartphone
Key exclusion criteria (3 listed)
- 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)
- Prior head and neck radiation and/or chemotherapy
- Medications that modulate or suppress the inflammatory system
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 |
|---|---|---|
| FIRE Trial/Track Your Happiness notificationsAll participants will receive notifications to their smart phones 3 times a day for 12 weeks. They will be asked questions related to burning mouth, to exercise as well as non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?" | Other | FIRE Trial Participants |
Primary outcome
Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time
Time frame: 12 weeks
Track Your Happiness app on smartphone and/or text base notification system will collect data in real time on people's experiences across a random sample of the moments of their lives through surveys. Participants will receive a notification on their phone at three random times each day and be prompted to answer questions adapted from the FIRE questionnaire related to burning mouth syndrome symptoms.
1 secondary outcome
Salivary Biomarkers
Time frame: Baseline and follow up visit (12 weeks after baseline)
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 12 Feb 2026.
- 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.
Eugene Ko, DDS principal investigator
Penn Dental School of Medicine, Center for Clinical and Translational Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burning Mouth Syndrome, run by University of Pennsylvania 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 5 inclusion and 3 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 12 Feb 2026. 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.
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 Eugene Ko, DDS (215-573-8177, PDMTranslationalMed@dental.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time (time frame: 12 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 12 Feb 2026.