NCT02580734

Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).

Detailed description

This is a crossover trial involving a total of 20 patients with Burning Mouth Syndrome, considered a chronic neuropathic pain. In two consecutive treatment periods, both 8 week long, each patient receives externally indistinguishable capsules (placebo or melatonin). A 4 weeks wash-out period is applied, between these two periods. The capsules contain either placebo or 3 mg-melatonin (4 time/day for a total of 12 mg/day of melatonin). The primary endpoint is the change in pain intensity at the end of each treatment period, measured using VAS, verbal intensity score and NRS, as well as number of oral sites affected by the burning sensation. Furthermore, data from quality of life, anxiety and sleep questionnaires are collected (sf-36, HAM-A, ESS, MOS). Adverse effects are carefully recorded as well as blood samples, in order to measure serum melatonin levels during the trial.

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	melatonin	Cross-over randomized clinical trials

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-05-01
• Completion: 2015-10-01
• First posted: 2015-10-20
• Last updated: 2015-10-27