NCT07506018

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Aug 2028

First Submitted

Initial submission to the registry

March 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 16, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

March 24, 2026

Last Update Submit

July 16, 2026

Conditions

StomatitisPainBurning MouthBurning Mouth SyndromeOral Dysesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Oral Health Impact Profile-14 (OHIP-14) total score

    28 days

  • Change in Oral Health Impact Profile-14 (OHIP-14) score (dichotomized)

    28 days

  • Incidence of adverse events by severity and relatedness

    28 days

Study Arms (1)

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.

Device: MucoLock Oral Gel

Interventions

MucoLock Oral GelDEVICE

15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days

MucoLock™ Topical Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 17379153BACKGROUND

  • 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.

    PMID: 23772971BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

StomatitisPainBurning Mouth Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alessandro Villa, DDS, PhD, MPH

    Miami Cancer Institute at Baptist Health, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Villa, DDS, PhD, MPH

CONTACT

(786) 596-2000Alessandro.Villa@baptisthealth.net

Wilfred W Hendron, II

CONTACT

(786) 596-2000Wilfred.Hendronii@baptisthealth.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 1, 2026

Study Start

July 16, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)