Reducing Patient Memory Recall in the Burning Mouth Patient Population

February 11, 2026 updated by: University of Pennsylvania

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Eugene Ko, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population will be patients who have been diagnosed with burning mouth syndrome by Oral Medicine specialists.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FIRE Trial Participants
This study only has one group. All participants will receive the same intervention (smart phone app/texting notifications).
Other: FIRE Trial/Track Your Happiness notifications
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?"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Biomarkers
Time Frame: Baseline and follow up visit (12 weeks after baseline)
The relationship between salivary biomarkers and burning mouth syndrome (BMS) symptoms.
Baseline and follow up visit (12 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Eugene Ko, DDS, Penn Dental School of Medicine, Center for Clinical and Translational Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 843642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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