Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

NCT ID: NCT02580734

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-10-31

Brief Summary

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

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.

Conditions

Burning Mouth Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

tablet without melatonin

Group Type: PLACEBO_COMPARATOR

melatonin

Intervention Type: DIETARY_SUPPLEMENT

Cross-over randomized clinical trials

melatonin

tablet with melatonin

Group Type: EXPERIMENTAL

melatonin

Intervention Type: DIETARY_SUPPLEMENT

Cross-over randomized clinical trials

Interventions

melatonin

Cross-over randomized clinical trials

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

ANDREA SARDELLA

Associate Professor of Oral Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BMS2013

Identifier Type: -

Identifier Source: org_study_id