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/NCT05962619</url>
    </required_header>
    <id_info>
      <org_study_id>AHAI</org_study_id>
      <nct_id>NCT05962619</nct_id>
    </id_info>
    <brief_title>Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection</brief_title>
    <official_title>Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection in Management of Temporomandibular Joint Dysfunction in the Form of Anterior Disc Displacement With Reduction : a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Comparison between Arthrocentesis alone arthrocentesis with hyaluronic acid injection in&#xD;
        management of temporomandibular joint dysfunction in the form of anterior disc displacement&#xD;
        with reduction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Temporomandibular joint (TMJ) anterior disc displacement (ADD) is one of the most common TMJ&#xD;
        disorders.It can occur in all age groups, with a high prevalence in adolescents .&#xD;
  &#xD;
        ADD often presents with clicking, joint pain, a limited range of mouth opening.&#xD;
        Furthermore,ADD might lead to osteoarthrosis .&#xD;
  &#xD;
        Since ADD of the TMJ can lead to various harmful outcomes, how to manage ADD is considered a&#xD;
        key problem for most TMJ experts. It has been difficult for most clinicians to select a&#xD;
        suitable method for ADD patients with different grades of severitis ). Initially, these&#xD;
        conditions can be managed conservatively by employing techniques such as occlusal splint&#xD;
        therapy, physiotherapy, pharmacotherapy and occlusal treatments. If Medical treatment fails,&#xD;
        minimally invasive (sodium hyaluronate or corticosteroid infiltrations and arthrocentesis)&#xD;
        and invasive treatments (arthroscopy, arthroplasty, arthrotomy, discectomy, condylotomy) are&#xD;
        formed ). Sodium hyaluronate is a buffered solution of hyaluronate acid sodium salt, which is&#xD;
        an essential component of the cartilage.It acts against the disintegration of the&#xD;
        extracellular matrix.It reduces friction, and it features an anti-inflamatory effect. It is&#xD;
        indicated for the treatment of osteoarthritic symptoms and inflammatory degenerative joint&#xD;
        disease). Intra-articular hyaluronic acid injection provides long-term palliative effects on&#xD;
        symptoms and signs of TMJ pain .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mouth opening</measure>
      <time_frame>Three months</time_frame>
      <description>Maximum inter-incisal opening (MIO): measured by Vernier caliper in millimeters (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors. Preoperative and postoperative measurement of MIO would help in evaluation of improvement in mouth opening after arthrocentesis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tempero mandibular joint pain</measure>
      <time_frame>One month</time_frame>
      <description>Pain was assessed using visual analogue scale (VAS):&#xD;
  which ranges from zero to 10 (where zero refers to no pain, 1:3 mild pain, 4:6 moderate pain, 7:9 severe pain and 10 maximum pain) assessing pre and post operative will provide good evidence about effect of arthrocentesis in decrease Tempero mandibular joint pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clicking</measure>
      <time_frame>Three months</time_frame>
      <description>Clicking was assessed as its presence or absence where zero refers to absence of clicking, 1 indicates decrease in sound and frequency of clicking, and 2 indicates presence of clicking.Assessment of clicking showed that there was statistically significant difference between the two groups along the evaluation intervals. There was statistically significant difference between clicking scores at the baseline when compared to the follow-up intervals within both groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Temporomandibular Joint Dysfunction Syndrome</condition>
    <condition>Arthrocenteses</condition>
    <condition>Hyaluronic Acid</condition>
    <arm_group>
      <arm_group_label>Arthrocentesis alone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Arthrocentesis alone in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.by lavage by normal saline and during the lavage the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>arthrocentesis with hyaluronic acid injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction. after arthrocentesis is completed, lavage is done by hyaluronic acid injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>arthrocentesis alone</intervention_name>
      <description>The procedure is done under general anesthesia. The patient is seated inclined at a 45 degree angle with the head turned to contralateral side. The points of needle insertion on the skin, are as follow: a line is drawn from the middle of the tragus to the outer canthus of the eye. The posterior entrance point is located along the canthotragal line, 10 mm from the middle of the tragus line and 2 mm below, the anterior entrance point is placed 10 mm further forward along the line and 10 mm below it . A needle connected to a 10 ml syringe with the Ringer's lactate solution is then inserted into the superior compartment (posterior point), and solution is injected . Another needle is then inserted into the area of articular eminence to enable the free flow of solution through the superior compartment. During the lavage, the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions</description>
      <arm_group_label>Arthrocentesis alone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>arthrocentesis with hyaluronic acid injection</intervention_name>
      <description>in this group Once arthrocentesis is completed, an ampule of sodium HA (Hyalgan 1 ml) is connected to the needle in situ And 0.5 ml injected into the superior joint space. Pressure dressing is placed in site of injection. so We use arthrocentesis hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction</description>
      <arm_group_label>arthrocentesis with hyaluronic acid injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults with age between( 18-45) years&#xD;
  &#xD;
            -  Both genders&#xD;
  &#xD;
            -  The cases ciinically have either of ( limitation of mouth opening , pre-auricular pain&#xD;
               , headache, temporal, and occipital tenderness ) and radiologically (MRI) diagnosed as&#xD;
               ADD with reduction&#xD;
  &#xD;
            -  The patients have symptom durations for more than 3 months with medical treatment.&#xD;
  &#xD;
            -  Patients whom did not respond to medical treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous TMJ surgery or previous arthrocentesis.&#xD;
  &#xD;
            -  Patients with arthritis or history of condylar trauma&#xD;
  &#xD;
            -  Patients with degenerative change of the condylar head and with facial asymmetry,&#xD;
               retrognathism, or prognathism&#xD;
  &#xD;
            -  Severe co-morbid conditions (uncontrolled diabetes, Hypertenion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahmed Hussien, MBBH</last_name>
      <phone>01014417626</phone>
      <email>ahmed.s7s1929@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammed MD Osman, MD</last_name>
      <phone>01223971586</phone>
      <email>dr.osman@aun.edu.eg</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Ahmed Mohammed Hussein Ali</investigator_full_name>
      <investigator_title>Principle investigator</investigator_title>
    </responsible_party>
    <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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyaluronic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05962619
  org study id: AHAI
  nct id: NCT05962619
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Comparison between Arthrocentesis alone arthrocentesis with hyaluronic acid injection in
        management of temporomandibular joint dysfunction in the form of anterior disc displacement
        with reduction.
  Temporomandibular joint (TMJ) anterior disc displacement (ADD) is one of the most common TMJ
        disorders.It can occur in all age groups, with a high prevalence in adolescents .
  
        ADD often presents with clicking, joint pain, a limited range of mouth opening.
        Furthermore,ADD might lead to osteoarthrosis .
  
        Since ADD of the TMJ can lead to various harmful outcomes, how to manage ADD is considered a
        key problem for most TMJ experts. It has been difficult for most clinicians to select a
        suitable method for ADD patients with different grades of severitis ). Initially, these
        conditions can be managed conservatively by employing techniques such as occlusal splint
        therapy, physiotherapy, pharmacotherapy and occlusal treatments. If Medical treatment fails,
        minimally invasive (sodium hyaluronate or corticosteroid infiltrations and arthrocentesis)
        and invasive treatments (arthroscopy, arthroplasty, arthrotomy, discectomy, condylotomy) are
        formed ). Sodium hyaluronate is a buffered solution of hyaluronate acid sodium salt, which is
        an essential component of the cartilage.It acts against the disintegration of the
        extracellular matrix.It reduces friction, and it features an anti-inflamatory effect. It is
        indicated for the treatment of osteoarthritic symptoms and inflammatory degenerative joint
        disease). Intra-articular hyaluronic acid injection provides long-term palliative effects on
        symptoms and signs of TMJ pain .
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Mouth opening
  time frame: Three months
  description: Maximum inter-incisal opening (MIO): measured by Vernier caliper in millimeters (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors. Preoperative and postoperative measurement of MIO would help in evaluation of improvement in mouth opening after arthrocentesis
  measure: Tempero mandibular joint pain
  time frame: One month
  description: Pain was assessed using visual analogue scale (VAS):
  which ranges from zero to 10 (where zero refers to no pain, 1:3 mild pain, 4:6 moderate pain, 7:9 severe pain and 10 maximum pain) assessing pre and post operative will provide good evidence about effect of arthrocentesis in decrease Tempero mandibular joint pain
  measure: Clicking
  time frame: Three months
  description: Clicking was assessed as its presence or absence where zero refers to absence of clicking, 1 indicates decrease in sound and frequency of clicking, and 2 indicates presence of clicking.Assessment of clicking showed that there was statistically significant difference between the two groups along the evaluation intervals. There was statistically significant difference between clicking scores at the baseline when compared to the follow-up intervals within both groups
  arm group label: Arthrocentesis alone
  arm group type: Experimental
  description: Arthrocentesis alone in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.by lavage by normal saline and during the lavage the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions.
  arm group label: arthrocentesis with hyaluronic acid injection
  arm group type: Experimental
  description: arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction. after arthrocentesis is completed, lavage is done by hyaluronic acid injection
  intervention type: Procedure
  intervention name: arthrocentesis alone
  description: The procedure is done under general anesthesia. The patient is seated inclined at a 45 degree angle with the head turned to contralateral side. The points of needle insertion on the skin, are as follow: a line is drawn from the middle of the tragus to the outer canthus of the eye. The posterior entrance point is located along the canthotragal line, 10 mm from the middle of the tragus line and 2 mm below, the anterior entrance point is placed 10 mm further forward along the line and 10 mm below it . A needle connected to a 10 ml syringe with the Ringer's lactate solution is then inserted into the superior compartment (posterior point), and solution is injected . Another needle is then inserted into the area of articular eminence to enable the free flow of solution through the superior compartment. During the lavage, the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions
  arm group label: Arthrocentesis alone
  intervention type: Procedure
  intervention name: arthrocentesis with hyaluronic acid injection
  description: in this group Once arthrocentesis is completed, an ampule of sodium HA (Hyalgan 1 ml) is connected to the needle in situ And 0.5 ml injected into the superior joint space. Pressure dressing is placed in site of injection. so We use arthrocentesis hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction
  arm group label: arthrocentesis with hyaluronic acid injection
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Ahmed Hussien, MBBH
  phone: 01014417626
  email: ahmed.s7s1929@gmail.com
  last name: Mohammed MD Osman, MD
  phone: 01223971586
  email: dr.osman@aun.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Ahmed Mohammed Hussein Ali
  investigator title: Principle investigator
  mesh term: Joint Diseases
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Hyaluronic Acid
  sharing ipd: No