Burning Mouth SyndromeBMS2013NCT02580734
Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
A study testing melatonin in people with Burning Mouth Syndrome, run by University of Milan.
Trial summary
The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 yrs suffering from burning mouth syndrome
Who cannot join
- epilepsy
- pregnancy
- concomitant treatment with melatonin
- concomitant anticoagulants
- night time working persons
About this study
Official title: Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).
Read the 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
- Being tested
- melatonin
- Keywords
- burning mouth syndrome, treatment, oral chronic pain
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDietary supplement
Cross-over randomized clinical trials
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | tablet without melatonin Receives: Dietary Supplement: melatonin |
| melatonin | Experimental | tablet with melatonin Receives: Dietary Supplement: melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction/resolution of symptoms in BMS
Measured: within the first 60 days
Secondary outcomes (1)
improvement in quality of life
Measured: within the first 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANDREA SARDELLA, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580734
- Sponsor's protocol ID
- BMS2013
- Acronym
- BMS2013
- Status last verified
- Oct 2015
- First submitted
- 20 Dec 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02580734
- Acronym / sponsor ID
- BMS2013 / BMS2013
- Conditions
- Burning Mouth Syndrome
- Keywords
- burning mouth syndrome, treatment, oral chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: melatonintablet without melatonin |
| melatonin | Experimental | Dietary Supplement: melatonintablet with melatonin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over 18 yrs suffering from burning mouth syndrome
Key exclusion criteria (5 listed)
- epilepsy
- pregnancy
- concomitant treatment with melatonin
- concomitant anticoagulants
- night time working persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninCross-over randomized clinical trials | Dietary supplement | melatonin, placebo |
Primary outcome
Reduction/resolution of symptoms in BMS
Time frame: within the first 60 days
1 secondary outcome
improvement in quality of life
Time frame: within the first 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin in people with Burning Mouth Syndrome, run by University of Milan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction/resolution of symptoms in BMS (time frame: within the first 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.