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

University of Milan

Status: Completed

Conditions: Burning Mouth Syndrome

Treatments: Dietary Supplement: melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02580734

BMS2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

tablet without melatonin

Treatment:

Dietary Supplement: melatonin

melatonin

Experimental group

Description:

tablet with melatonin

Treatment:

Dietary Supplement: melatonin