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

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

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

Study Overview

• Status: Completed
• Conditions: Burning Mouth Syndrome
• Intervention / Treatment: Dietary supplement: melatonin

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; tablet without melatonin	Dietary supplement: melatonin; Cross-over randomized clinical trials
Experimental: melatonin; tablet with melatonin	Dietary supplement: melatonin; Cross-over randomized clinical trials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction/resolution of symptoms in BMS	within the first 60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
improvement in quality of life	within the first 60 days

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Estimate): October 27, 2015
• Last Update Submitted That Met QC Criteria: October 25, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: treatment; burning mouth syndrome; oral chronic pain
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: BMS2013