MucoLock™ for Treatment of Stomatitis

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT07506018
Status
Recruiting

Conditions

  • Burning Mouth
  • Burning Mouth Syndrome
  • Oral Dysesthesia
  • Pain
  • Stomatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MucoLock Oral Gel — DEVICE
    15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Visual Analog Scale (VAS) pain score [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Alessandro Villa, DDS, PhD, MPH
(786) 596-2000
Wilfred W Hendron, II
(786) 596-2000
Alessandro Villa, DDS, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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