<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03788733</url>
  </required_header>
  <id_info>
    <org_study_id>University Murcia</org_study_id>
    <nct_id>NCT03788733</nct_id>
  </id_info>
  <brief_title>The Efficacy of Melatonin in the Burning Mouth Syndrome</brief_title>
  <acronym>BMS</acronym>
  <official_title>Study of the Efficacy of Melatonin in the Burning Mouth Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Burning mouth ( BMS) syndrome is the oral disorder characterized by an intraoral burning&#xD;
      sensation for which no medical or dental cause can be found. The Headache Classification&#xD;
      Committee of the International Headache Society (IHS) defines (BMS) as an ''intraoral burning&#xD;
      or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3&#xD;
      months, without clinically evident causative lesions''. (BMS) is a common, chronic problem&#xD;
      that has a negative impact on quality of life.&#xD;
&#xD;
      A wide variety of medications have been proposed for treating (BMS) both topical and&#xD;
      systemic. Unfortunately, no treatment seems to offer assured results. Melatonin is a&#xD;
      naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral&#xD;
      administration and is well tolerated. It enhances sleep Melatonin also may help sleep&#xD;
      disturbances associated with (BMS) ; however, this remains to be proven.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to establish whether melatonin can aid in reducing pain improve&#xD;
      sleep quality in (BMS)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Anticipated">December 14, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Questionnaire</measure>
    <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</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Questionnaire</measure>
    <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</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral Pain</measure>
    <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)</time_frame>
    <description>Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Pain</measure>
    <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)</time_frame>
    <description>Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire ORAL Quality of life</measure>
    <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.</time_frame>
    <description>Questionnaire OHIP 14 Oral quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire ORAL Quality of life</measure>
    <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.</time_frame>
    <description>Questionnaire OHIP 14 Oral quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Sleep Disorders, Circadian Rhythm</condition>
  <arm_group>
    <arm_group_label>Melatonin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin 3 mg</intervention_name>
    <description>1 time a day for 8 weeks</description>
    <arm_group_label>Melatonin</arm_group_label>
    <other_name>melatonin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral</intervention_name>
    <description>1 time a day for 8 weeks</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per&#xD;
             day over more than 3 months, without clinically evident causative lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or current therapy with melatonin&#xD;
&#xD;
          -  Allergy or hypersensitivity to melatonin&#xD;
&#xD;
          -  Less than 18 years old.&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lopez-Jornet Pia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oral Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lopez-Jornet Pia, PhD</last_name>
    <phone>639473308</phone>
    <email>majornet@um.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lopez-Jornet Pia</name>
      <address>
        <city>Murcia</city>
        <state>N/A = Not Applicable</state>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lopez-Jornet Pia</last_name>
      <phone>639473308</phone>
      <email>majornet@um.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>29694465</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>28460563</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Murcia</investigator_affiliation>
    <investigator_full_name>Pia Lopez Jornet</investigator_full_name>
    <investigator_title>Head of Oral Medicine</investigator_title>
  </responsible_party>
  <keyword>Burning mouth syndrome,</keyword>
  <keyword>melatonin</keyword>
  <keyword>pain</keyword>
  <keyword>sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burning Mouth Syndrome</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03788733
org study id: University Murcia
nct id: NCT03788733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
The purpose of this study is to establish whether melatonin can aid in reducing pain improve
      sleep quality in (BMS)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 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
description: The Pittsburgh Sleep Quality Index (PSQI)
measure: 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
description: The Pittsburgh Sleep Quality Index (PSQI)
measure: 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)
description: Visual Analogue Scale (VAS)
measure: 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)
description: Visual Analogue Scale (VAS)
measure: 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.
description: Questionnaire OHIP 14 Oral quality of life
measure: 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.
description: Questionnaire OHIP 14 Oral quality of life
arm group label: Melatonin
arm group type: Experimental
description: Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks
arm group label: placebo
arm group type: Placebo Comparator
description: ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks
intervention type: Drug
intervention name: Melatonin 3 mg
description: 1 time a day for 8 weeks
arm group label: Melatonin
other name: melatonin
intervention type: Drug
intervention name: Placebo Oral
description: 1 time a day for 8 weeks
arm group label: placebo
other name: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lopez-Jornet Pia, PhD
role: Principal Investigator
affiliation: Oral Medicine
last name: Lopez-Jornet Pia, PhD
phone: 639473308
email: majornet@um.es
facility: 
status: Recruiting
contact: 
country: Spain
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.
PMID: 29694465
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.
PMID: 28460563
responsible party type: Principal Investigator
investigator affiliation: Universidad de Murcia
investigator full name: Pia Lopez Jornet
investigator title: Head of Oral Medicine
mesh term: Burning Mouth Syndrome
mesh term: Sleep Wake Disorders
mesh term: Sleep Disorders, Circadian Rhythm
mesh term: Burns
mesh term: Melatonin
sharing ipd: No