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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02580734
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : October 27, 2015
Information provided by (Responsible Party):
ANDREA SARDELLA, University of Milan

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

Condition or disease Intervention/treatment Phase
Burning Mouth Syndrome Dietary Supplement: melatonin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Melatonin

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

Primary Outcome Measures :
  1. Reduction/resolution of symptoms in BMS [ Time Frame: within the first 60 days ]

Secondary Outcome Measures :
  1. improvement in quality of life [ Time Frame: within the first 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: ANDREA SARDELLA, Associate Professor of Oral Diseases, University of Milan Identifier: NCT02580734     History of Changes
Other Study ID Numbers: BMS2013
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by ANDREA SARDELLA, University of Milan:
burning mouth syndrome
oral chronic pain

Additional relevant MeSH terms:
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Burning Mouth Syndrome
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants