NCT07506018

MucoLock™ for Treatment of Stomatitis

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study