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Efficacy of Melatonin in Burning Mouth Syndrome (BMS) — BMS2013  

Burning Mouth Syndrome Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02580734
Study type Interventional
Source University of Milan
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date October 2015
View Details
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