Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

Burning Mouth Syndrome Clinical Trial

— BMS2013  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580734
• Other study ID #: BMS2013
• Status: Completed
• Phase: N/A
• First received: December 20, 2013
• Last updated: October 25, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients over 18 yrs suffering from burning mouth syndrome

Exclusion Criteria:

• epilepsy

• pregnancy

• concomitant treatment with melatonin

• concomitant anticoagulants

• night time working persons

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

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Dietary Supplement:
• melatonin
Cross-over randomized clinical trials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction/resolution of symptoms in BMS		within the first 60 days	No
Secondary	improvement in quality of life		within the first 60 days	No