Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-09 @ 3:14 PM
Study NCT ID:
NCT02580734
Status:
COMPLETED
Last Update Posted:
2015-10-27
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
Sponsor:
University of Milan
Organization:
Study Overview
Official Title:
Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMS2013
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: