Clinical Trial: Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.

Sponsor: University of Milan

Current Primary Outcome: Reduction/resolution of symptoms in BMS [ Time Frame: within the first 60 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: improvement in quality of life [ Time Frame: within the first 60 days ]

Original Secondary Outcome: Same as current

Information By: University of Milan

Dates:
Date Received: December 20, 2013
Date Started: March 2014
Date Completion:
Last Updated: October 25, 2015
Last Verified: October 2015