Burning mouth syndrome: a review and update.
Andy Sun, Kai-Ming Wu, Yi-Ping Wang...
https://pubmed.ncbi.nlm.nih.gov/23772971/Actively Recruiting
Led by Baptist Health South Florida · Updated on 2026-07-17
25
Participants Needed
1
Research Sites
N/A
Total Duration
This research evaluates how well MucoLock oral gel can be tolerated and how effectively it reduces mouth pain or burning sensations in adults with stomatitis and oral dysesthesia. The study focuses on adults aged 18 years and older who experience significant mouth sensitivity or burning, aiming to assess changes in pain levels and oral health impact over 28 days. Participants will use MucoLock oral gel as a topical solution by swishing 15 mL in the mouth for 5 minutes and then spitting it out. This will be done three times a day for 28 days. The study involves a single group where all participants receive this treatment. During the study, participants will be monitored for changes in mouth pain using a visual analog scale and oral health impact scores. Researchers will also track any adverse events related to the treatment. Participants will follow study instructions and complete assessments over the 28-day period to evaluate the treatments effects and safety.
CONDITIONS
MucoLock™ for Treatment of Stomatitis
A
Alessandro Villa, DDS, PhD, MPH
W
Wilfred W Hendron, II
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Baptist Health South Florida
Lead Sponsor
Professional Compounding Centers of America
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | MucoLock Oral Gel (investigational, single-group study) | Topical Oral Rinses (e.g., lidocaine, Magic mouthwash) (guideline-recommended, external context) |
|---|---|---|
| What it is | A topical oral gel designed as a mouth rinse, used three times daily for four weeks, being tested for reducing pain and burning in adults with oral dysesthesia. | Topical oral rinses with anesthetic or soothing ingredients (such as lidocaine or Magic mouthwash) are commonly used for short-term relief of pain and burning sensations in burning mouth syndrome. |
| Primary use | Investigated as a new topical therapy to reduce pain and burning in adults with burning mouth symptoms who are not currently using other topical oral pain treatments. | Used to provide temporary pain relief for people experiencing burning mouth syndrome or oral dysesthesia. |
| How it is given or performed | Participants rinsed with 15 mL of gel for 5 minutes, three times daily for 28 days, then spit out the gel without swallowing. | Typically used as an oral rinse or mouthwash at recommended intervals, with instructions to swish in the mouth for several minutes before spitting out. |
| Evidence status | Effectiveness and long-term safety are not yet established; clinical trial results are not available. | Topical rinses provide short-term symptom relief for some people with burning mouth syndrome, but long-term benefit is limited. |
| Important limitations | Single-group design without a placebo or active comparator; excludes participants who recently used topical mouth pain therapies or opioid medications; only short-term use (28 days) studied; safety and effect on long-term quality of life not yet known. | Topical rinses usually provide only temporary symptom relief, and frequent use is needed. Evidence for lasting benefit is limited; effect may vary between individuals. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants use MucoLock™ oral gel by swishing 15 mL in the mouth for 5 minutes and spitting it out, three times daily for 28 days.
Regular check-ins during the 28-day treatment period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Andy Sun, Kai-Ming Wu, Yi-Ping Wang...
https://pubmed.ncbi.nlm.nih.gov/23772971/Lauren L Patton, Michael A Siegel, Raphael Benoliel...
https://pubmed.ncbi.nlm.nih.gov/17379153/Baptist Health South Florida
Lead Sponsor
Professional Compounding Centers of America
Collaborating Sponsor