xml: <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/NCT06040190</url>
    </required_header>
    <id_info>
      <org_study_id>6.161.933</org_study_id>
      <nct_id>NCT06040190</nct_id>
    </id_info>
    <brief_title>Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome</brief_title>
    <official_title>Evaluation of the Effect of Different Treatments on Pain Scores and Self-reported Oral Health-related Quality of Life in Individuals With Burning Mouth Syndrome: a Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federal University of Minas Gerais</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federal University of Minas Gerais</source>
    <oversight_info>
      <has_dmc>Yes</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 (BMS) is characterized by a burning sensation on the tongue or other&#xD;
        areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in&#xD;
        postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified.&#xD;
        The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have&#xD;
        been proposed, yielding conflicting outcomes and underscoring the need for further&#xD;
        investigation.&#xD;
  &#xD;
        Patients with BMS appear to respond well to long-term therapy involving systemic&#xD;
        antidepressants and anxiolytics. The most promising therapeutic effects have been observed&#xD;
        with clonazepam, which leads to a significant reduction in pain when applied topically or&#xD;
        systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option,&#xD;
        showing positive results in alleviating BMS symptoms when compared to a placebo.&#xD;
        Photobiomodulation represents another non-pharmacological treatment possibility. It's&#xD;
        analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic&#xD;
        acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant&#xD;
        naturally produced within the body, contributing to the mitigation of skin aging and&#xD;
        reinforcing the effects of other biological antioxidants. Based on these findings, attempts&#xD;
        have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may&#xD;
        offer benefits in this context.&#xD;
  &#xD;
        Therefore, the objective of this study is to investigate, in adults with BMS, the impact of&#xD;
        different therapeutic approaches on frequency, intensity, and location of pain, as well as on&#xD;
        on quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain reduction</measure>
      <time_frame>baseline and 3 weeks</time_frame>
      <description>pain reduction measured by a visual analog scale and the short version of the McGill Pain Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>pain reduction</measure>
      <time_frame>baseline and 2 months</time_frame>
      <description>pain reduction measured by a visual analog scale and the short version of the</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>quality of life improvements</measure>
      <time_frame>baseline and 3 weeks</time_frame>
      <description>quality of life improvements measured by Oral Impacts on Daily Performance scores</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life improvements</measure>
      <time_frame>baseline and 2 months</time_frame>
      <description>quality of life improvements measured by Oral Impacts on Daily Performance</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Burning Mouth Syndrome</condition>
    <arm_group>
      <arm_group_label>topical placebo tablet</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>magnesium silicate placebo tablet three times a day for 21 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>artificial saliva rinse</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>5mL of artificial saliva rinse twice a day for 21 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>topical clonazepam tablet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2.0 mg Clonazepam tablet three times a day for 21 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>oral alpha-lipoic acid capsule</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>300 mg alpha-lipoic acid capsule twice a day for 60 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>topical phytotherapic capsaicin gel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>0.025 mg capsaicin gel 4 times a day for 14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>local photobiomodulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Photobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>topical placebo tablet</intervention_name>
      <description>Individuals will be instructed to dissolve half a tablet of placebo medication and hold the saliva near the painful oral sites without swallowing, for 3 minutes and then spit. Tablets will contain magnesium silicate, with the same color and flavor as the test medications. Researchers will provide a total of 32 tablets for each participant.</description>
      <arm_group_label>topical placebo tablet</arm_group_label>
      <other_name>magnesium silicate</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>artificial saliva rinse</intervention_name>
      <description>Individuals will be instructed to rinse with artificial saliva for 1 minute. Researchers will provide 600 ml of artificial saliva for each participant.</description>
      <arm_group_label>artificial saliva rinse</arm_group_label>
      <other_name>Biofarma pharmacy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>topical clonazepam tablet</intervention_name>
      <description>Individuals will be instructed to dissolve half a tablet of clonazepam and hold the saliva near the painful oral sites without swallowing for 3 minutes and then spit. Researchers will provide a total of 32 tablets for each participant.</description>
      <arm_group_label>topical clonazepam tablet</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>oral alpha-lipoic acid capsule</intervention_name>
      <description>Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid.</description>
      <arm_group_label>oral alpha-lipoic acid capsule</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>topical phytotherapic capsaicin gel</intervention_name>
      <description>Participants in this group will to apply the gel containing tocapsaicin on painful oral sites.</description>
      <arm_group_label>topical phytotherapic capsaicin gel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>local photobiomodulation</intervention_name>
      <description>Photobiomodulation will be applied during 10 seconds per point at 56 points (three on the vestibular mucosa of the 4 quadrants, four on each labial mucosa, six on each of the two buccal mucosae, six on the hard palate, four on each lateral edge of the tongue, six on the dorsum of the tongue, and four sublingual points) with an intermediate distance of 2 mm. A dose of 12 J/cm² per session will be applied in continuous mode for 10 sessions. The 10 sessions will be applied twice a week for 5 consecutive weeks. The LASER will be applied perpendicularly in contact with the mucosa. All patients and the clinician will wear protective glasses.</description>
      <arm_group_label>local photobiomodulation</arm_group_label>
      <other_name>photodynamic therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  burning mouth syndrome;&#xD;
  &#xD;
            -  oral pain that recurs daily for &gt; 2 hours per day for &gt; 3 months;&#xD;
  &#xD;
            -  pain with burning quality and felt superficially in the oral mucosa;&#xD;
  &#xD;
            -  oral mucosa appears normal&#xD;
  &#xD;
            -  oral clinical examination, including sensory tests, is normal;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy;&#xD;
  &#xD;
            -  oral mucosal lesions;&#xD;
  &#xD;
            -  systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe,&#xD;
               Zinc, and folic acid;&#xD;
  &#xD;
            -  gastroesophageal reflux;&#xD;
  &#xD;
            -  previous head and neck radiotherapy;&#xD;
  &#xD;
            -  Sjogren's disease;&#xD;
  &#xD;
            -  allergies;&#xD;
  &#xD;
            -  candidiasis;&#xD;
  &#xD;
            -  unstimulated saliva flow &lt; 0.25 ml/min and stimulated flow &lt; 1.0 ml/min will be&#xD;
               excluded;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fernando O Costa, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Federal University of Minas Gerais</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fernando O Costa, PhD</last_name>
      <phone>+55 31 9954-0657</phone>
      <email>focperio@uol.com.br</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
      <investigator_full_name>Fernando O Costa</investigator_full_name>
      <investigator_title>Titular Professor</investigator_title>
    </responsible_party>
    <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>Thioctic Acid</mesh_term>
      <mesh_term>Clonazepam</mesh_term>
      <mesh_term>Capsaicin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual patient data will not be shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040190
  org study id: 6.161.933
  nct id: NCT06040190
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other
        areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in
        postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified.
        The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have
        been proposed, yielding conflicting outcomes and underscoring the need for further
        investigation.
  
        Patients with BMS appear to respond well to long-term therapy involving systemic
        antidepressants and anxiolytics. The most promising therapeutic effects have been observed
        with clonazepam, which leads to a significant reduction in pain when applied topically or
        systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option,
        showing positive results in alleviating BMS symptoms when compared to a placebo.
        Photobiomodulation represents another non-pharmacological treatment possibility. It's
        analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic
        acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant
        naturally produced within the body, contributing to the mitigation of skin aging and
        reinforcing the effects of other biological antioxidants. Based on these findings, attempts
        have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may
        offer benefits in this context.
  
        Therefore, the objective of this study is to investigate, in adults with BMS, the impact of
        different therapeutic approaches on frequency, intensity, and location of pain, as well as on
        on quality of life.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: pain reduction
  time frame: baseline and 3 weeks
  description: pain reduction measured by a visual analog scale and the short version of the McGill Pain Questionnaire
  measure: pain reduction
  time frame: baseline and 2 months
  description: pain reduction measured by a visual analog scale and the short version of the
  measure: quality of life improvements
  time frame: baseline and 3 weeks
  description: quality of life improvements measured by Oral Impacts on Daily Performance scores
  measure: quality of life improvements
  time frame: baseline and 2 months
  description: quality of life improvements measured by Oral Impacts on Daily Performance
  arm group label: topical placebo tablet
  arm group type: Placebo Comparator
  description: magnesium silicate placebo tablet three times a day for 21 days
  arm group label: artificial saliva rinse
  arm group type: Active Comparator
  description: 5mL of artificial saliva rinse twice a day for 21 days
  arm group label: topical clonazepam tablet
  arm group type: Experimental
  description: 2.0 mg Clonazepam tablet three times a day for 21 days
  arm group label: oral alpha-lipoic acid capsule
  arm group type: Experimental
  description: 300 mg alpha-lipoic acid capsule twice a day for 60 days
  arm group label: topical phytotherapic capsaicin gel
  arm group type: Experimental
  description: 0.025 mg capsaicin gel 4 times a day for 14 days
  arm group label: local photobiomodulation
  arm group type: Experimental
  description: Photobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J.
  intervention type: Drug
  intervention name: topical placebo tablet
  description: Individuals will be instructed to dissolve half a tablet of placebo medication and hold the saliva near the painful oral sites without swallowing, for 3 minutes and then spit. Tablets will contain magnesium silicate, with the same color and flavor as the test medications. Researchers will provide a total of 32 tablets for each participant.
  arm group label: topical placebo tablet
  other name: magnesium silicate
  intervention type: Other
  intervention name: artificial saliva rinse
  description: Individuals will be instructed to rinse with artificial saliva for 1 minute. Researchers will provide 600 ml of artificial saliva for each participant.
  arm group label: artificial saliva rinse
  other name: Biofarma pharmacy
  intervention type: Drug
  intervention name: topical clonazepam tablet
  description: Individuals will be instructed to dissolve half a tablet of clonazepam and hold the saliva near the painful oral sites without swallowing for 3 minutes and then spit. Researchers will provide a total of 32 tablets for each participant.
  arm group label: topical clonazepam tablet
  intervention type: Dietary Supplement
  intervention name: oral alpha-lipoic acid capsule
  description: Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid.
  arm group label: oral alpha-lipoic acid capsule
  intervention type: Other
  intervention name: topical phytotherapic capsaicin gel
  description: Participants in this group will to apply the gel containing tocapsaicin on painful oral sites.
  arm group label: topical phytotherapic capsaicin gel
  intervention type: Radiation
  intervention name: local photobiomodulation
  description: Photobiomodulation will be applied during 10 seconds per point at 56 points (three on the vestibular mucosa of the 4 quadrants, four on each labial mucosa, six on each of the two buccal mucosae, six on the hard palate, four on each lateral edge of the tongue, six on the dorsum of the tongue, and four sublingual points) with an intermediate distance of 2 mm. A dose of 12 J/cm² per session will be applied in continuous mode for 10 sessions. The 10 sessions will be applied twice a week for 5 consecutive weeks. The LASER will be applied perpendicularly in contact with the mucosa. All patients and the clinician will wear protective glasses.
  arm group label: local photobiomodulation
  other name: photodynamic therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Fernando O Costa, PhD
  role: Principal Investigator
  affiliation: Federal University of Minas Gerais
  last name: Fernando O Costa, PhD
  phone: +55 31 9954-0657
  email: focperio@uol.com.br
  responsible party type: Principal Investigator
  investigator affiliation: Federal University of Minas Gerais
  investigator full name: Fernando O Costa
  investigator title: Titular Professor
  mesh term: Burning Mouth Syndrome
  mesh term: Syndrome
  mesh term: Burns
  mesh term: Thioctic Acid
  mesh term: Clonazepam
  mesh term: Capsaicin
  sharing ipd: No
  ipd description: Individual patient data will not be shared.