Recruiting

MucoLock™

Sponsor:

Baptist Health South Florida

Code:

NCT07506018

Conditions

Stomatitis

Pain

Burning Mouth

Burning Mouth Syndrome

Oral Dysesthesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MucoLock Oral Gel

Study Details

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.

Conditions

Stomatitis

Pain

Burning Mouth

Burning Mouth Syndrome

Oral Dysesthesia

Study ID

NCT07506018

Start date

Jul 16, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MucoLock Oral Gel

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Alessandro Villa, DDS, PhD, MPH

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

Wilfred W Hendron, II

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

Locations

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Contacts

Alessandro Villa, DDS, PhD, MPH

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

Wilfred W Hendron, II

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

Principal Investigator:

Alessandro Villa, DDS, PhD, MPH

More Information

Sponsor

Baptist Health South Florida

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baptist Health South Florida on 2026-07-17.