Burning Mouth, Burning Mouth Syndrome, Oral Dysesthesia, Pain, Stomatitis
Conditions
Brief summary
The purpose of this research is to test how well people can tolerate MucoLock™ as a treatment for mouth pain or burning sensation and how well it works to reduce mouth pain or burning sensation. Study participants will be asked to use MucoLock™ topical solution as a "swish and spit" solution (similar to mouthwash) three times per day for 5 minutes each time, for 28 days.
Interventions
DEVICEMucoLock Oral Gel
15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days
Sponsors
Baptist Health South Florida
Professional Compounding Centers of America
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Individuals with oral dysesthesia (worst VAS sensitivity/burning score ≥ 7 over the last week) * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Inability to comply with study instructions * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements\* * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data. * Advanced kidney disease * Patients receiving antineoplastic therapy \[e.g., tyrosine kinase inhibitors (TKIs), radiation\] that could increase the risk of oral dysesthesia * Known altered mental status, encephalopathy, or cognition impairment * Ataxia * Known alcohol use disorder * Concomitant opioid therapy * Diagnosis of oral cancer currently undergoing therapy * Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)\* * Any opioid pain medication\* * Treatment with another investigational drug or other intervention within 2 weeks. Patients will be recommended to stop previous medication for 2 weeks before starting the study treatment. (asterisk) \*Modifiable criteria, with a timeframe of 2 weeks for a washout period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) pain score | 28 days | Pain will be assessed using the VAS with a score of 0 being no pain and 10 being worst possible pain. Pre- to post-treatment change in VAS pain score will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Health Impact Profile-14 (OHIP-14) total score | 28 days | The OHIP-14 is a 14-item questionnaire measuring how oral conditions affect quality of life, focusing on discomfort, disability, and dysfunction. It uses a 5-point Likert scale (0=Never to 4=Very Often) across seven domains: functional limitation, physical pain, psychological discomfort, physical/psychological/social disability, and handicap. The total score can range from 0 to 56, with lower scores representing better outcomes and higher scores representing worse outcomes. The pre-to-post treatment change for each item and for all items combined will be assessed. |
| Change in Oral Health Impact Profile-14 (OHIP-14) score (dichotomized) | 28 days | The OHIP-14 is a 14-item questionnaire measuring how oral conditions affect quality of life, focusing on discomfort, disability, and dysfunction. It uses a 5-point Likert scale (0=Never to 4=Very Often) across seven domains: functional limitation, physical pain, psychological discomfort, physical/psychological/social disability, and handicap. Each question will be dichotomized and classified as 'treatment response' if the answer is 'not at all', or 'slightly' to a question such as "how isolated do you feel as a result of this oral condition", and pre-to-post treatment improvement will be assessed. |
| Incidence of adverse events by severity and relatedness | 28 days | Adverse events will be assessed at the end of treatment using the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). Adverse event severity will be graded on the scale of 1 (mild) to 5 (death). Relatedness to the study treatment will be determined (unrelated or unlikely to be related vs. possibly, probably, or definitely related). The number of adverse events will be tabulated by grade and relatedness (e.g., number of Grade 1 related events, number of Grade 1 unrelated events, etc.). |
Countries
United States
Contacts
CONTACTAlessandro Villa, DDS, PhD, MPH
CONTACTWilfred W Hendron, II
PRINCIPAL_INVESTIGATORAlessandro Villa, DDS, PhD, MPH
Miami Cancer Institute at Baptist Health, Inc.
Outcome results
None listed