<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/NCT04475614</url>
  </required_header>
  <id_info>
    <org_study_id>01072018</org_study_id>
    <nct_id>NCT04475614</nct_id>
  </id_info>
  <brief_title>Therapeutic Options for Treatment of Burning Mouth Syndrome</brief_title>
  <official_title>Different Therapeutic Options for Burning Mouth Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zagreb</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of&#xD;
      life and does not have an adequate therapeutic option. The purpose of this study is to&#xD;
      determine the most effective treatment option for burning mouth syndrome, among oral&#xD;
      probiotics, low-level laser, B-vitamin injections and informative treatment only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)</measure>
    <time_frame>up to two months (follow up was one month after the end of treatment, in each patient)</time_frame>
    <description>change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective burning symptoms</measure>
    <time_frame>up to two months (follow up was one month after the end of treatment, in each patient)</time_frame>
    <description>change of patient's subjective burning symptoms measured on visual analogue scale (VAS) grading from 0 to 10 (0- without burning, 10- the worst possible burning)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Burning Mouth Syndrome</condition>
  <arm_group>
    <arm_group_label>informative</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients in this group received only verbal and written information about their condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oral probiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group, beside verbal and written information about their condition, received also oral probiotics. They were instructed to melt one lozenge in the mouth in the evening, after tooth brushing and flossing, for one month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low level laser treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group, beside verbal and written information about their condition, received a total of ten low level laser treatments, for ten days consecutively excluding weekends.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B-vitamin injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group, beside verbal and written information about their condition, received a total of nine B vitamin injections, every other day, intra muscular.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BioGaia Prodentis lozenges</intervention_name>
    <description>oral probiotics</description>
    <arm_group_label>oral probiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>low level laser treatment with Ga-Al-As laser</intervention_name>
    <description>low level laser treatment</description>
    <arm_group_label>low level laser treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>B vitamin injections (Neurobion, Merck, Darmstadt, Germany)</intervention_name>
    <description>intra muscular vitamin injections</description>
    <arm_group_label>B-vitamin injections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed with burning mouth syndrome and excluded local and systemic causes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have received treatment for burning mouth earlier&#xD;
&#xD;
          -  patients with local or systemic causes of burning mouth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>39 Years</minimum_age>
    <maximum_age>83 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Dental Medicine, University of Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zagreb</investigator_affiliation>
    <investigator_full_name>Božana Lončar Brzak</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>burning mouth syndrome</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burning Mouth Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin B Complex</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/NCT04475614
org study id: 01072018
nct id: NCT04475614
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of
      life and does not have an adequate therapeutic option. The purpose of this study is to
      determine the most effective treatment option for burning mouth syndrome, among oral
      probiotics, low-level laser, B-vitamin injections and informative treatment only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)
time frame: up to two months (follow up was one month after the end of treatment, in each patient)
description: change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14)
measure: Change in subjective burning symptoms
time frame: up to two months (follow up was one month after the end of treatment, in each patient)
description: change of patient's subjective burning symptoms measured on visual analogue scale (VAS) grading from 0 to 10 (0- without burning, 10- the worst possible burning)
arm group label: informative
arm group type: No Intervention
description: The patients in this group received only verbal and written information about their condition.
arm group label: oral probiotics
arm group type: Experimental
description: The patients in this group, beside verbal and written information about their condition, received also oral probiotics. They were instructed to melt one lozenge in the mouth in the evening, after tooth brushing and flossing, for one month.
arm group label: low level laser treatment
arm group type: Experimental
description: The patients in this group, beside verbal and written information about their condition, received a total of ten low level laser treatments, for ten days consecutively excluding weekends.
arm group label: B-vitamin injections
arm group type: Experimental
description: The patients in this group, beside verbal and written information about their condition, received a total of nine B vitamin injections, every other day, intra muscular.
intervention type: Dietary Supplement
intervention name: BioGaia Prodentis lozenges
description: oral probiotics
arm group label: oral probiotics
intervention type: Procedure
intervention name: low level laser treatment with Ga-Al-As laser
description: low level laser treatment
arm group label: low level laser treatment
intervention type: Dietary Supplement
intervention name: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)
description: intra muscular vitamin injections
arm group label: B-vitamin injections
criteria: 
gender: All
minimum age: 39 Years
maximum age: 83 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: University of Zagreb
investigator full name: Božana Lončar Brzak
investigator title: Assistant Professor
mesh term: Burning Mouth Syndrome
mesh term: Syndrome
mesh term: Burns
mesh term: Vitamin B Complex
sharing ipd: No