StomatitisNCT07506018
MucoLock™ for Treatment of Stomatitis
A study testing MucoLock Oral Gel in people with Stomatitis and Pain, run by Baptist Health South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis, Pain, Burning Mouth
- What is being tested?
- MucoLock Oral Gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Alessandro Villa, DDS, PhD, MPH, (786) 596-2000, Alessandro.Villa@baptisthealth.net
Wilfred W Hendron, II, (786) 596-2000, Wilfred.Hendronii@baptisthealth.net
About this study
Official title: A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia
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.
- Conditions
- Stomatitis, Pain, Burning Mouth, Burning Mouth Syndrome, Oral Dysesthesia
- Being tested
- MucoLock Oral Gel
- Medical subject headings
- Stomatitis, Pain, Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucoLock Oral GelDevice
15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days
| Study group | Role | What they receive |
|---|---|---|
| MucoLock™ Topical Solution | Experimental | MucoLock™ oral gel will be used as a "swish and spit" (similar to using mouthwash), 15 mL three times per day, for 5 minutes each time, for 28 days. Receives: Device: MucoLock Oral Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) pain score
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.
Measured: 28 days
Secondary outcomes (3)
Change in Oral Health Impact Profile-14 (OHIP-14) total score
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.
Measured: 28 days
Change in Oral Health Impact Profile-14 (OHIP-14) score (dichotomized)
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.
Measured: 28 days
Incidence of adverse events by severity and relatedness
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.).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start16 Jul 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Professional Compounding Centers of America
- Responsible party
- Sponsor
- Investigators
- Alessandro Villa, DDS, PhD, MPH, Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506018
- Sponsor's protocol ID
- 2025-VIL-001
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Patton LL, Siegel MA, Benoliel R, De Laat A. Management of burning mouth syndrome: systematic review and management recommendations. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S39.e1-13. doi: 10.1016/j.tripleo.2006.11.009.
PubMed 17379153Sun A, Wu KM, Wang YP, Lin HP, Chen HM, Chiang CP. Burning mouth syndrome: a review and update. J Oral Pathol Med. 2013 Oct;42(9):649-55. doi: 10.1111/jop.12101. Epub 2013 Jun 16.
PubMed 23772971US Food & Drug Administration. MucoLock Oral Gel. 510(K) Premarket Notification. 2021; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203091