NCT02580734

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

December 20, 2013

Last Update Submit

October 25, 2015

Conditions

Burning Mouth Syndrome

Keywords

burning mouth syndrometreatmentoral chronic pain

Outcome Measures

Primary Outcomes (1)

  • Reduction/resolution of symptoms in BMS

    within the first 60 days

Secondary Outcomes (1)

  • improvement in quality of life

    within the first 60 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

tablet without melatonin

Dietary Supplement: melatonin

melatonin

EXPERIMENTAL

tablet with melatonin

Dietary Supplement: melatonin

Interventions

melatoninDIETARY_SUPPLEMENT

Cross-over randomized clinical trials

melatoninplacebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 yrs suffering from burning mouth syndrome

You may not qualify if:

  • epilepsy
  • pregnancy
  • concomitant treatment with melatonin
  • concomitant anticoagulants
  • night time working persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral Diseases

Study Record Dates

First Submitted

December 20, 2013

First Posted

October 20, 2015

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10