Management of burning mouth syndrome: systematic review and management recommendations.
Lauren L Patton, Michael A Siegel, Raphael Benoliel...
https://pubmed.ncbi.nlm.nih.gov/17379153Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07506018
A Phase II Open-Label Trial of MucoLock17 Oral Rinse for Treatment of Stomatitis with Oral Dysesthesia
Led by Baptist Health South Florida · Updated on 2026-04-20
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
P
Professional Compounding Centers of America
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is focused on people experiencing mouth pain or burning sensations, specifically those with stomatitis characterized by oral dysesthesia. Researchers are evaluating how well participants tolerate and respond to MucoLock17, a topical oral rinse, to reduce mouth discomfort. The study is designed as a Phase II open-label trial to assess these effects over a 28-day period. Participants will use MucoLock17 oral gel as a "swish and spit" rinse, similar to mouthwash, by rinsing with 15 mL three times daily for five minutes each time, over 28 days. This treatment approach is being studied without a placebo or comparison group, focusing on the active solution's impact. During the study, participants will be monitored for changes in their mouth pain using the Visual Analog Scale (VAS) after 28 days. Other assessments include changes in oral health impact, adverse events by severity and relatedness, and overall safety. Participants will be asked to adhere to the treatment schedule and report their symptoms, with the total study duration lasting 28 days.
CONDITIONS
Brief Title
MucoLock™ for Treatment of Stomatitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Individuals with oral dysesthesia having a worst Visual Analog Scale (VAS) sensitivity or burning score of 7 or higher over the last week
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Inability to comply with study instructions
- Uncontrolled illness or psychiatric/social conditions that limit compliance
- Any condition or abnormality that may compromise safety or data quality
- Advanced kidney disease
- Receiving antineoplastic therapies that increase oral dysesthesia risk
- Known altered mental status or cognition impairment
- Ataxia
- Known alcohol use disorder
- Current opioid therapy
- Diagnosis of oral cancer undergoing therapy
- Current use of topical therapy for mouth pain
- Use of any opioid pain medication
- Treatment with another investigational drug or intervention within 2 weeks prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 28 days
Participants use MucoLock Oral Gel as an oral rinse, swishing 15 mL for 5 minutes three times per day for 28 days.
Visits scheduled as per study protocol to monitor treatment progress
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
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Research Team
A
Alessandro Villa, DDS, PhD, MPH
W
Wilfred W Hendron, II
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Burning mouth syndrome: a review and update.
Andy Sun, Kai-Ming Wu, Yi-Ping Wang...
https://pubmed.ncbi.nlm.nih.gov/23772971