RECRUITING

Reducing Patient Memory Recall in the Burning Mouth Patient Population

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-14
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05819697

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Individuals aged 18 years and older
  2. 2. Willing and able to provide informed consent
  3. 3. Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist
  4. 4. Willing to submit a saliva sample
  5. 5. Have continuous access to a smartphone
  1. 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. 2. Prior head and neck radiation and/or chemotherapy
  3. 3. Medications that modulate or suppress the inflammatory system

Contacts and Locations

Study Contact

Eugene Ko, DDS
CONTACT
215-573-8177
PDMTranslationalMed@dental.upenn.edu

Principal Investigator

Eugene Ko, DDS
PRINCIPAL_INVESTIGATOR
Penn Dental School of Medicine, Center for Clinical and Translational Research

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Eugene Ko, DDS, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-03-14
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Burning Mouth Syndrome