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The Efficacy of Melatonin in the Burning Mouth Syndrome (BMS)

Primary Purpose

Sleep Disorders, Circadian Rhythm

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Melatonin 3 mg
Placebo Oral
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm focused on measuring Burning mouth syndrome,, melatonin, pain, sleep

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions

Exclusion Criteria:

  • Previous or current therapy with melatonin
  • Allergy or hypersensitivity to melatonin
  • Less than 18 years old.
  • Pregnant

Sites / Locations

  • Lopez-Jornet PiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

placebo

Arm Description

Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks

ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks

Outcomes

Primary Outcome Measures

Sleep Questionnaire
The Pittsburgh Sleep Quality Index (PSQI)
Sleep Questionnaire
The Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Oral Pain
Visual Analogue Scale (VAS)
Oral Pain
Visual Analogue Scale (VAS)
Questionnaire ORAL Quality of life
Questionnaire OHIP 14 Oral quality of life
Questionnaire ORAL Quality of life
Questionnaire OHIP 14 Oral quality of life

Full Information

First Posted
December 22, 2018
Last Updated
December 26, 2018
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03788733
Brief Title
The Efficacy of Melatonin in the Burning Mouth Syndrome
Acronym
BMS
Official Title
Study of the Efficacy of Melatonin in the Burning Mouth Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
June 14, 2019 (Anticipated)
Study Completion Date
December 14, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Burning mouth ( BMS) syndrome is the oral disorder characterized by an intraoral burning sensation for which no medical or dental cause can be found. The Headache Classification Committee of the International Headache Society (IHS) defines (BMS) as an ''intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions''. (BMS) is a common, chronic problem that has a negative impact on quality of life. A wide variety of medications have been proposed for treating (BMS) both topical and systemic. Unfortunately, no treatment seems to offer assured results. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep Melatonin also may help sleep disturbances associated with (BMS) ; however, this remains to be proven.
Detailed Description
The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm
Keywords
Burning mouth syndrome,, melatonin, pain, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Melatonin 3 mg
Other Intervention Name(s)
melatonin
Intervention Description
1 time a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Oral
Other Intervention Name(s)
Placebo
Intervention Description
1 time a day for 8 weeks
Primary Outcome Measure Information:
Title
Sleep Questionnaire
Description
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame
day 0 .The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 8 weeks of treatment. A negative score means that the sleep
Title
Sleep Questionnaire
Description
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame
8 weeks.The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 8 weeks of treatment. A negative score means that the sleep
Secondary Outcome Measure Information:
Title
Oral Pain
Description
Visual Analogue Scale (VAS)
Time Frame
day 0 .Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)
Title
Oral Pain
Description
Visual Analogue Scale (VAS)
Time Frame
8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)
Title
Questionnaire ORAL Quality of life
Description
Questionnaire OHIP 14 Oral quality of life
Time Frame
day 0 The instrument consists of 14 items that explore different aspects of oral function and quality of life. The score ranges from 0 to 70, with higher scores corresponding to poorer oral quality of life.
Title
Questionnaire ORAL Quality of life
Description
Questionnaire OHIP 14 Oral quality of life
Time Frame
8 weeks The instrument consists of 14 items that explore different aspects of oral function and quality of life. The score ranges from 0 to 70, with higher scores corresponding to poorer oral quality of life.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions Exclusion Criteria: Previous or current therapy with melatonin Allergy or hypersensitivity to melatonin Less than 18 years old. Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lopez-Jornet Pia, PhD
Phone
639473308
Email
majornet@um.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lopez-Jornet Pia, PhD
Organizational Affiliation
Oral Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lopez-Jornet Pia
City
Murcia
State/Province
N/A = Not Applicable
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lopez-Jornet Pia
Phone
639473308
Email
majornet@um.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29694465
Citation
Varoni EM, Lo Faro AF, Lodi G, Carrassi A, Iriti M, Sardella A. Melatonin Treatment in Patients with Burning Mouth Syndrome: A Triple-Blind, Placebo-Controlled, Crossover Randomized Clinical Trial. J Oral Facial Pain Headache. 2018 Spring;32(2):178-188. doi: 10.11607/ofph.1913.
Results Reference
background
PubMed Identifier
28460563
Citation
Xie Z, Chen F, Li WA, Geng X, Li C, Meng X, Feng Y, Liu W, Yu F. A review of sleep disorders and melatonin. Neurol Res. 2017 Jun;39(6):559-565. doi: 10.1080/01616412.2017.1315864. Epub 2017 May 1.
Results Reference
result

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The Efficacy of Melatonin in the Burning Mouth Syndrome

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