<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/NCT03773640</url>
  </required_header>
  <id_info>
    <org_study_id>1072.6120.116.2018</org_study_id>
    <nct_id>NCT03773640</nct_id>
  </id_info>
  <brief_title>The Application of Radio Frequency Waves</brief_title>
  <official_title>The Application of Radio Frequency Waves in Supportive Treatment of Temporomandibular Joint Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jagiellonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jagiellonian University</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>
      The aim of the study was to evaluate the influence of radio waves on the functioning of&#xD;
      masseter muscles in the course of painful functional disorders of the organ, and thus the&#xD;
      usefulness of these procedures in the treatment supporting temporomandibular joint&#xD;
      dysfunction.&#xD;
&#xD;
      Material and method The study group I (20 patients) and control group II (20 patients)&#xD;
      consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting&#xD;
      Room of Temporomandibular Joint Dysfunction in Institute of Dentistry in Krakow to undertake&#xD;
      prosthetic treatment of pain form of temporomandibular disorders with the dominant muscle&#xD;
      component.&#xD;
&#xD;
      Study group (I) consist of patients who were treated with the occlusal splints and radio&#xD;
      frequency currents. In the case of application of radiation to the muscle area, the energy&#xD;
      was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar&#xD;
      technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for&#xD;
      ultrasound examinations.&#xD;
&#xD;
      The control group ( II) consisted of 20 patients treated with occlusion splints and&#xD;
      sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were&#xD;
      applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical&#xD;
      substance was 25%Voltaren gel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, the number of patients applying for prosthetic treatment due to painful&#xD;
      forms of temporomandibular joint dysfunction has been increasing. Temporomandibular joints&#xD;
      disorders (TMJD )include dysfunction of the masticatory muscles of the stomatognathic system,&#xD;
      temporomandibular joints and the surrounding structures. There are often associated with&#xD;
      abnormal conditions of occlusion.&#xD;
&#xD;
      The aim of the study was to evaluate the influence of radio waves on the functioning of&#xD;
      masseter muscles in the course of painful functional disorders of the organ, and thus the&#xD;
      usefulness of these procedures in the treatment supporting temporomandibular joint&#xD;
      dysfunction.&#xD;
&#xD;
      Material and method The study group I (20 patients) and control group II (20 patients)&#xD;
      consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting&#xD;
      Room of Temporomandibular Joint Dysfunction in Institute of Dentistry in Krakow to undertake&#xD;
      prosthetic treatment of pain form of temporomandibular disorders with the dominant muscle&#xD;
      component.&#xD;
&#xD;
      Study group (I) consist of patients who were treated with the occlusal splints and radio&#xD;
      frequency currents. In the case of application of radiation to the muscle area, the energy&#xD;
      was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar&#xD;
      technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for&#xD;
      ultrasound examinations.&#xD;
&#xD;
      The control group ( II) consisted of 20 patients treated with occlusion splints and&#xD;
      sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were&#xD;
      applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical&#xD;
      substance was 25%Voltaren gel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">December 5, 2018</completion_date>
  <primary_completion_date type="Actual">December 5, 2018</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>
    <intervention_model_description>The study group I (20 patients) and control group II (20 patients) consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting Room of Temporomandibular Joint Dysfunction at The Institute of Dentistry in Krakow to undertake prosthetic treatment of pain form of temporomandibular disorders, with the dominant muscle component.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of intensity of pain (VAS - scale)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessment of intensity of pain of mastication muscles with the use of combined VAS and WNRS scales in own description.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Temporomandibular Joint Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>The study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radio frequency currents</intervention_name>
    <description>Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.</description>
    <arm_group_label>The study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sonophoresis</intervention_name>
    <description>The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.</description>
    <arm_group_label>The control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pain form of temporomandibular joints dysfunction,&#xD;
&#xD;
          -  the required age range,&#xD;
&#xD;
          -  good general state of health,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the will (consent) of the patient,&#xD;
&#xD;
          -  the presence of a general diseases,&#xD;
&#xD;
          -  the presence of traumas,&#xD;
&#xD;
          -  the presence of local inflammations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jagiellonian University Department of Prosthetic Dentistry</name>
      <address>
        <city>Kraków</city>
        <state>Małopolskie</state>
        <zip>31-155</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jagiellonian University</investigator_affiliation>
    <investigator_full_name>Malgorzata Pihut</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>temporomandibular joint dysfunction,</keyword>
  <keyword>supportive treatment,</keyword>
  <keyword>occlusal splint,</keyword>
  <keyword>radiofreqency,</keyword>
  <keyword>physiotherapy</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>
  </condition_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/NCT03773640
org study id: 1072.6120.116.2018
nct id: NCT03773640
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to evaluate the influence of radio waves on the functioning of
      masseter muscles in the course of painful functional disorders of the organ, and thus the
      usefulness of these procedures in the treatment supporting temporomandibular joint
      dysfunction.

      Material and method The study group I (20 patients) and control group II (20 patients)
      consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting
      Room of Temporomandibular Joint Dysfunction in Institute of Dentistry in Krakow to undertake
      prosthetic treatment of pain form of temporomandibular disorders with the dominant muscle
      component.

      Study group (I) consist of patients who were treated with the occlusal splints and radio
      frequency currents. In the case of application of radiation to the muscle area, the energy
      was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar
      technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for
      ultrasound examinations.

      The control group ( II) consisted of 20 patients treated with occlusion splints and
      sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were
      applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical
      substance was 25%Voltaren gel.
In recent years, the number of patients applying for prosthetic treatment due to painful
      forms of temporomandibular joint dysfunction has been increasing. Temporomandibular joints
      disorders (TMJD )include dysfunction of the masticatory muscles of the stomatognathic system,
      temporomandibular joints and the surrounding structures. There are often associated with
      abnormal conditions of occlusion.

      The aim of the study was to evaluate the influence of radio waves on the functioning of
      masseter muscles in the course of painful functional disorders of the organ, and thus the
      usefulness of these procedures in the treatment supporting temporomandibular joint
      dysfunction.

      Material and method The study group I (20 patients) and control group II (20 patients)
      consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting
      Room of Temporomandibular Joint Dysfunction in Institute of Dentistry in Krakow to undertake
      prosthetic treatment of pain form of temporomandibular disorders with the dominant muscle
      component.

      Study group (I) consist of patients who were treated with the occlusal splints and radio
      frequency currents. In the case of application of radiation to the muscle area, the energy
      was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar
      technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for
      ultrasound examinations.

      The control group ( II) consisted of 20 patients treated with occlusion splints and
      sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were
      applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical
      substance was 25%Voltaren gel.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study group I (20 patients) and control group II (20 patients) consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting Room of Temporomandibular Joint Dysfunction at The Institute of Dentistry in Krakow to undertake prosthetic treatment of pain form of temporomandibular disorders, with the dominant muscle component.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assessment of intensity of pain (VAS - scale)
time frame: 10 weeks
description: Assessment of intensity of pain of mastication muscles with the use of combined VAS and WNRS scales in own description.
arm group label: The study group
arm group type: Experimental
description: Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.
arm group label: The control group
arm group type: Active Comparator
description: The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.
intervention type: Device
intervention name: Radio frequency currents
description: Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.
arm group label: The study group
intervention type: Drug
intervention name: Sonophoresis
description: The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.
arm group label: The control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Jagiellonian University
investigator full name: Malgorzata Pihut
investigator title: Associate Professor
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome