MucoLock™ for Treatment of Stomatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Stomatitis; Burning Mouth Syndrome; Burning Mouth; Oral Dysesthesia
• Intervention / Treatment: Device: MucoLock Oral Gel

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro Villa, DDS, PhD, MPH; Phone Number: (786) 596-2000; Email: Alessandro.Villa@baptisthealth.net
• Study Contact Backup: Name: Wilfred W Hendron, II; Phone Number: (786) 596-2000; Email: Wilfred.Hendronii@baptisthealth.net

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute at Baptist Health, Inc.
      • Contact: Alessandro Villa, DDS, PhD, MPH; Phone Number: (786) 596-2000; Email: Alessandro.Villa@baptisthealth.net
      • Contact: Wilfred W Hendron, II; Phone Number: (786) 596-2000; Email: Wilfred.Hendronii@baptisthealth.net
      • Principal Investigator: Alessandro Villa, DDS, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MucoLock™ Topical Solution; 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.	Device: MucoLock Oral Gel; 15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.).	28 days

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Collaborators: Professional Compounding Centers of America
• Investigators: Principal Investigator: Alessandro Villa, DDS, PhD, MPH, Miami Cancer Institute at Baptist Health, Inc.

Publications and helpful links

General 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.
• Sun 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.
• US Food & Drug Administration. MucoLock Oral Gel. 510(K) Premarket Notification. 2021; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203091

Helpful Links

• Miami Cancer Institute at Baptist Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Stomatitis; Burning Mouth Syndrome
• Other Study ID Numbers: 2025-VIL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes