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BMS: The Efficacy of Melatonin in the Burning Mouth Syndrome

Sponsor
Universidad de Murcia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03788733
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 3 mg
  • Drug: Placebo Oral
 N/A

Detailed Description

The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 14, 2018
Anticipated Primary Completion Date :
Jun 14, 2019
Anticipated Study Completion Date :
Dec 14, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sleep Questionnaire [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Lopez-Jornet Pia Murcia N/A = Not Applicable Spain 30008

    Sponsors and Collaborators

    • Universidad de Murcia

    Investigators

    • Principal Investigator: Lopez-Jornet Pia, PhD, Oral Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pia Lopez Jornet, Head of Oral Medicine, Universidad de Murcia
    ClinicalTrials.gov Identifier:
    NCT03788733
    Other Study ID Numbers:
    • University Murcia
    First Posted:
    Dec 28, 2018
    Last Update Posted:
    Dec 28, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Head of Oral Medicine, Universidad de Murcia
    Burning mouth syndrome,
    melatonin
    pain
    sleep
    Additional relevant MeSH terms:
    Burning Mouth Syndrome
    Sleep Wake Disorders
    Sleep Disorders, Circadian Rhythm
    Burns
    Melatonin

    Study Results

    No Results Posted as of Dec 28, 2018