<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/NCT02997410</url>
  </required_header>
  <id_info>
    <org_study_id>TCelakil</org_study_id>
    <nct_id>NCT02997410</nct_id>
  </id_info>
  <brief_title>Ozone Therapy for Masticatory Muscle Pain (OTMMP)</brief_title>
  <acronym>OTMMP</acronym>
  <official_title>Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the efficacy of bio-oxidative ozone application in the treatment of&#xD;
      TMD of muscular origin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ozone is a natural pale blue gas that can be found in the atmosphere. Medical grade ozone is&#xD;
      a powerful oxidizing agent which can be produced commercially in ozone generators. Ozone can&#xD;
      have effects on blood components and positively affect oxygen metabolism, cell energy,&#xD;
      immunomodulation and microcirculation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month</measure>
    <time_frame>Change from Baseline Pain Values (kg/cm2) at 1 month</time_frame>
    <description>Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months</measure>
    <time_frame>Change from Baseline Pain Values (kg/cm2) at 3 months</time_frame>
    <description>Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Pain Scores on the Visual Analog Scale at 1 month</measure>
    <time_frame>Change from Baseline Pain Scores at 1 month</time_frame>
    <description>The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Pain Scores on the Visual Analog Scale at 3 months</measure>
    <time_frame>Change from Baseline Pain Scores at 3 months</time_frame>
    <description>The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional examination</measure>
    <time_frame>Baseline, 1 month and 3 months</time_frame>
    <description>Functional examination is based on Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) including extra-oral and cervical muscle pains, joint pains, mouth openings, lateral excursions and protrusion. Vertical and horizontal movements are measured with a plastic millimetre-scale ruler. Participants are asked to report any pain during muscle and joint palpation, and this information is recorded using a verbal scale: 0, no pain; 1, mild pain; 2, moderate pain; and 3, severe pain.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Orofacial Pain</condition>
  <condition>Temporomandibular Joint Disorders</condition>
  <arm_group>
    <arm_group_label>Ozone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Occlusal splint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Occlusal splint use every night over a period of 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ozone</intervention_name>
    <arm_group_label>Ozone</arm_group_label>
    <other_name>OzonytroneX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo (for Ozone)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dental treatment with occlusal splint</intervention_name>
    <arm_group_label>Occlusal splint</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of myofascial pain according to the Research Diagnostic Criteria for&#xD;
             Temporomandibular Disorder (RDC/TMD)&#xD;
&#xD;
          -  Natural posterior occlusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any TMJ internal derangement&#xD;
&#xD;
          -  Inflammatory connective tissue disease&#xD;
&#xD;
          -  Psychiatric problem&#xD;
&#xD;
          -  Tumour&#xD;
&#xD;
          -  Hearth disease or pacemaker&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Other orofacial region disease symptoms (e.g. toothache, neuralgia, migraine)&#xD;
&#xD;
          -  Treatment or medication use for headache or bruxism in the last 2 years&#xD;
&#xD;
          -  Local skin infection over the masseter or temporal muscle&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Dogan M, Ozdemir Dogan D, Duger C, Ozdemir Kol I, Akpinar A, Mutaf B, Akar T. Effects of high-frequency bio-oxidative ozone therapy in temporomandibular disorder-related pain. Med Princ Pract. 2014;23(6):507-10. doi: 10.1159/000365355. Epub 2014 Sep 3.</citation>
    <PMID>25196631</PMID>
  </reference>
  <reference>
    <citation>Daif ET. Role of intra-articular ozone gas injection in the management of internal derangement of the temporomandibular joint. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):e10-4. doi: 10.1016/j.tripleo.2011.08.006. Epub 2012 Feb 28.</citation>
    <PMID>22677023</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>June 15, 2017</last_update_submitted>
  <last_update_submitted_qc>June 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Tamer Celakil</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Ozone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Facial Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02997410
org study id: TCelakil
nct id: NCT02997410
lead sponsor: 
has dmc: Yes
This study investigates the efficacy of bio-oxidative ozone application in the treatment of
      TMD of muscular origin.
Ozone is a natural pale blue gas that can be found in the atmosphere. Medical grade ozone is
      a powerful oxidizing agent which can be produced commercially in ozone generators. Ozone can
      have effects on blood components and positively affect oxygen metabolism, cell energy,
      immunomodulation and microcirculation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month
time frame: Change from Baseline Pain Values (kg/cm2) at 1 month
description: Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
measure: Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months
time frame: Change from Baseline Pain Values (kg/cm2) at 3 months
description: Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
measure: Change From Baseline in Pain Scores on the Visual Analog Scale at 1 month
time frame: Change from Baseline Pain Scores at 1 month
description: The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
measure: Change From Baseline in Pain Scores on the Visual Analog Scale at 3 months
time frame: Change from Baseline Pain Scores at 3 months
description: The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
measure: Functional examination
time frame: Baseline, 1 month and 3 months
description: Functional examination is based on Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) including extra-oral and cervical muscle pains, joint pains, mouth openings, lateral excursions and protrusion. Vertical and horizontal movements are measured with a plastic millimetre-scale ruler. Participants are asked to report any pain during muscle and joint palpation, and this information is recorded using a verbal scale: 0, no pain; 1, mild pain; 2, moderate pain; and 3, severe pain.
arm group label: Ozone
arm group type: Experimental
description: Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
arm group label: Occlusal splint
arm group type: Experimental
description: Occlusal splint use every night over a period of 4 weeks.
intervention type: Device
intervention name: Ozone
arm group label: Ozone
other name: OzonytroneX
intervention type: Device
intervention name: Placebo (for Ozone)
arm group label: Placebo
intervention type: Device
intervention name: Dental treatment with occlusal splint
arm group label: Occlusal splint
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
citation: Dogan M, Ozdemir Dogan D, Duger C, Ozdemir Kol I, Akpinar A, Mutaf B, Akar T. Effects of high-frequency bio-oxidative ozone therapy in temporomandibular disorder-related pain. Med Princ Pract. 2014;23(6):507-10. doi: 10.1159/000365355. Epub 2014 Sep 3.
PMID: 25196631
citation: Daif ET. Role of intra-articular ozone gas injection in the management of internal derangement of the temporomandibular joint. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):e10-4. doi: 10.1016/j.tripleo.2011.08.006. Epub 2012 Feb 28.
PMID: 22677023
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Tamer Celakil
investigator title: Research Assistant
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Myalgia
mesh term: Facial Pain
mesh term: Salicylic Acid