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

Primary Purpose

Burning Mouth Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
melatonin
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring burning mouth syndrome, treatment, oral chronic pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    placebo

    melatonin

    Arm Description

    tablet without melatonin

    tablet with melatonin

    Outcomes

    Primary Outcome Measures

    Reduction/resolution of symptoms in BMS

    Secondary Outcome Measures

    improvement in quality of life

    Full Information

    First Posted
    December 20, 2013
    Last Updated
    October 25, 2015
    Sponsor
    University of Milan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02580734
    Brief Title
    Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
    Acronym
    BMS2013
    Official Title
    Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Milan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burning Mouth Syndrome
    Keywords
    burning mouth syndrome, treatment, oral chronic pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    tablet without melatonin
    Arm Title
    melatonin
    Arm Type
    Experimental
    Arm Description
    tablet with melatonin
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    melatonin
    Intervention Description
    Cross-over randomized clinical trials
    Primary Outcome Measure Information:
    Title
    Reduction/resolution of symptoms in BMS
    Time Frame
    within the first 60 days
    Secondary Outcome Measure Information:
    Title
    improvement in quality of life
    Time Frame
    within the first 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

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