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NCT Number: NCT05819697

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.

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Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Eugene Ko, DDS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

FIRE Trial/Track Your Happiness notifications

Other

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?"

Primary outcomes

  1. 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.

Secondary outcomes

  1. Salivary Biomarkers

    Time frame: Baseline and follow up visit (12 weeks after baseline)

    The relationship between salivary biomarkers and burning mouth syndrome (BMS) symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Eugene Ko, DDS

CONTACT

[email protected]

215-573-8177

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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