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| Name | Class |
|---|---|
| Professional Compounding Centers of America | INDUSTRY |
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The purpose of this research is to test how well people can tolerate MucoLockâ„¢ 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 MucoLockâ„¢ 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MucoLockâ„¢ Topical Solution | Experimental | MucoLockâ„¢ 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MucoLock Oral Gel | Device | 15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
(asterisk) *Modifiable criteria, with a timeframe of 2 weeks for a washout period.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Villa, DDS, PhD, MPH | Contact | (786) 596-2000 | Alessandro.Villa@baptisthealth.net | |
| Wilfred W Hendron, II | Contact | (786) 596-2000 | Wilfred.Hendronii@baptisthealth.net |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Villa, DDS, PhD, MPH | Miami Cancer Institute at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health, Inc. | Recruiting | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17379153 | Background | 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. | |
| 23772971 | Background | 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. |
| Label | URL |
|---|---|
| Miami Cancer Institute at Baptist Health, Inc. | View source |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D010146 | Pain |
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 28 days |
| 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. | 28 days |
| 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.). | 28 days |
| Background | 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |