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Completed

NCT Number: NCT02580734

Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

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

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Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

Cross-over randomized clinical trials

Primary outcomes

  1. Reduction/resolution of symptoms in BMS

    Time frame: within the first 60 days

Secondary outcomes

  1. improvement in quality of life

    Time frame: within the first 60 days

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Acronym: BMS2013

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2015
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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