MucoLock™ for Treatment of Stomatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MucoLock Oral Gel
Device15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: MucoLock™ Topical SolutionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
28 daysSecondary outcomes
1
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.
Time frame
28 days2
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.
Time frame
28 days3
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.).
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baptist Health South Florida
Lead sponsor
Professional Compounding Centers of America
Collaborator
Source ClinicalTrials.gov