An interventional study of melatonin in Burning Mouth Syndrome, sponsored by University of Milan. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-10-27.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).
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.
44 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's enrollment of 20 is below the median of 42 across 35 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
tablet without melatonin
Dietary Supplement: melatonin
tablet with melatonin
Dietary Supplement: melatonin
Cross-over randomized clinical trials
Reduction/resolution of symptoms in BMS
Time frame: within the first 60 days
improvement in quality of life
Time frame: within the first 60 days
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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University of Milan