Recruiting

Burning Mouth Syndrome

Sponsor:

University of Pennsylvania

Code:

NCT05819697

Conditions

Burning Mouth Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FIRE Trial/Track Your Happiness notifications

Study Details

Brief 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 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.

Conditions

Burning Mouth Syndrome

Study ID

NCT05819697

Start date

Mar 14, 2023

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

FIRE Trial Participants

This study only has one group. All participants will receive the same intervention (smart phone app/texting notifications).

Interventions

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?"

Primary outcome measure

  • Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Eugene Ko, DDS

215-573-8177PDMTranslationalMed@dental.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Eugene Ko, DDS

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • burning mouth syndrome
  • oral pain
  • burning mouth
  • chronic intraoral burning sensation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-12.