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

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ClinicalTrials.gov Identifier: NCT03788733
Recruitment Status : Unknown
Verified December 2018 by Pia Lopez Jornet, Universidad de Murcia.
Recruitment status was:  Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pia Lopez Jornet, Universidad de Murcia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sleep Disorders, Circadian Rhythm Drug: Melatonin 3 mg Drug: Placebo Oral Not Applicable

Detailed Description:
The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Efficacy of Melatonin in the Burning Mouth Syndrome
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : June 14, 2019
Estimated Study Completion Date : December 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Melatonin
Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks
 Drug: Melatonin 3 mg
1 time a day for 8 weeks
Other Name: melatonin
Placebo Comparator: placebo
ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks
 Drug: Placebo Oral
1 time a day for 8 weeks
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Sleep Questionnaire [ 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 ]
    The Pittsburgh Sleep Quality Index (PSQI)

  2. Sleep Questionnaire [ 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 ]
    The Pittsburgh Sleep Quality Index (PSQI)


Secondary Outcome Measures :
  1. Oral Pain [ 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) ]
    Visual Analogue Scale (VAS)

  2. Oral Pain [ 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) ]
    Visual Analogue Scale (VAS)

  3. Questionnaire 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. ]
    Questionnaire OHIP 14 Oral quality of life

  4. Questionnaire 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. ]
    Questionnaire OHIP 14 Oral quality of life


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788733


Contacts
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Contact: Lopez-Jornet Pia, PhD 639473308 majornet@um.es

Locations
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Spain
Lopez-Jornet Pia Recruiting
Murcia, N/A = Not Applicable, Spain, 30008
Contact: Lopez-Jornet Pia    639473308    majornet@um.es   
Sponsors and Collaborators
Universidad de Murcia
Investigators
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Principal Investigator: Lopez-Jornet Pia, PhD Oral Medicine
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Pia Lopez Jornet, Head of Oral Medicine, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03788733    
Other Study ID Numbers: University Murcia
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Pia Lopez Jornet, Universidad de Murcia:
Burning mouth syndrome,
melatonin
pain
sleep
Additional relevant MeSH terms:
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Burning Mouth Syndrome
Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Burns
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases
 Chronobiology Disorders
Dyssomnias
Occupational Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants