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NCT Number: NCT07506018

MucoLock™ for Treatment of Stomatitis

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.

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Key information

Conditions

Stomatitis Burning Mouth Burning Mouth Syndrome Mouth Diseases Neurologic Manifestations Oral Dysesthesia Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

Location status: Recruiting

Location contact

Alessandro Villa, DDS, PhD, MPH

CONTACT

[email protected]

(786) 596-2000

Alessandro Villa, DDS, PhD, MPH

PRINCIPAL_INVESTIGATOR

Wilfred W Hendron, II

CONTACT

[email protected]

(786) 596-2000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MucoLock Oral Gel

Device

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

Primary outcomes

  1. Change in Visual Analog Scale (VAS) pain score

    Time frame: 28 days

    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.

Secondary outcomes

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

    Time frame: 28 days

    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.

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

    Time frame: 28 days

    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.

  3. Incidence of adverse events by severity and relatedness

    Time frame: 28 days

    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.).

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Villa, DDS, PhD, MPH

CONTACT

[email protected]

(786) 596-2000

Wilfred W Hendron, II

CONTACT

[email protected]

(786) 596-2000

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Collaborators

  • Professional Compounding Centers of America

Registry information

Official study title

A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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