Reducing Patient Memory Recall in the Burning Mouth Patient Population

NCT05819697 | Recruiting

• 1 other identifier: 843642
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Salivary Biomarkers

  Baseline and follow up visit (12 weeks after baseline)

Study Arms (1)

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

Interventions

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?"

FIRE Trial Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Burning Mouth Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Eugene Ko, DDS

  Penn Dental School of Medicine, Center for Clinical and Translational Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Ko, DDS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 19, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)