<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/NCT02237040</url>
  </required_header>
  <id_info>
    <org_study_id>SYSU-Clinical Treatment</org_study_id>
    <nct_id>NCT02237040</nct_id>
  </id_info>
  <brief_title>A New Treatment Protocol for Paediatric Mandibular Condylar Fractures</brief_title>
  <official_title>Management of Paediatric Mandibular Condylar Fractures Simply With a Mandibular Manipulation Technique and Mouth Opening Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar&#xD;
      fractures in pediatrics treated simply with a mandibular manipulation technique accompanied&#xD;
      by mouth opening training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a consensus on nonsurgical approach is a priority for paediatric condylar fractures,&#xD;
      but a recognized nonsurgical method for treating children with condylar fractures is still a&#xD;
      highly debated theme. The purpose of this study is to investigate the effect of a new&#xD;
      nonsurgical method simply using a mandibular manipulation technique and mouth opening&#xD;
      training in managing children with condylar fractures.&#xD;
&#xD;
      Spiral computed tomography (CT) or Cone beam computed tomography (CBCT) will be taken before&#xD;
      treatment when the patients present to the department. Condylar fracture classification is&#xD;
      defined according to SPIESSL &amp; SCHROLL.&#xD;
&#xD;
      These patients are then treated termly with a mandibular manipulation technique reported by&#xD;
      Farrar, which is an effective treatment method to reset the physiological positional&#xD;
      relationship between condyle and disc. Neither intermaxillary fixation nor guiding elastics&#xD;
      will be used after hand manipulation. Then patients are told to persist in mouth opening&#xD;
      training at home everyday. The mouth opening training is performed as follow: patients are&#xD;
      told to try to close his mouth in intercuspal position at first, then open their mouth as&#xD;
      wide as possible(the reference maximal mouth opening is as wide as the mouth opening after&#xD;
      treatment in last time), then closed back to the intercuspal position again. Patients are&#xD;
      recommended to follow up at every week at first two months, then every 2 weeks at third&#xD;
      months, 6th months, 1 year after first treatment, then yearly afterward. The mandibular&#xD;
      manipulation is performed at every follow-up. Meanwhile, the maximal mouth opening (MMO) is&#xD;
      recorded before and after hand manipulation treatment. So do the occlusion status, deviation&#xD;
      during opening, as well as subjective symptoms of temporomandibular joints. At first moth,&#xD;
      3rd month, 6th month, 1 year, then every year after first treatment, CBCT is performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2010</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with accepted anatomical and functional recovery</measure>
    <time_frame>up to 1 year</time_frame>
    <description>&quot;accepted anatomical and functional recover&quot; was defined as follow:&#xD;
the maximal mouth opening is more than 32 millimeter&#xD;
the fractured condylar with complete remodeling&#xD;
No joint pain, clicking of the TMJ, and opening deviation(Normal mandibular movement without pathologic deviation was defined as lateral sliding less than 5 millimeter out of the midline of face during opening), unacceptable malocclusion(accepted occlusion is defined as stable intercuspidation between dental arches), dietary limitation was detected.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Fractures</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are treated with the mandibular manipulation technique termly and mouth opening training</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mandibular manipulation technique</intervention_name>
    <description>patients are treated with The mandibular manipulation technique reported by Farrar, which was an effective treatment method to reset the physiological positional relationship between condyle and disc.Then patients are told to persist in mouth opening training at home everyday. The mouth opening training is performed as follow: patients are told to try to close his mouth in intercuspal position at first, then open their mouth as wide as possible(the reference maximal mouth opening is as wide as the mouth opening after treatment in last time), then close back to the intercuspal position again.</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suffer mandibular condylar fracture&#xD;
&#xD;
          -  voluntary Patient&#xD;
&#xD;
          -  with no concomitant displaced jaw fractures&#xD;
&#xD;
          -  the fracture-treatment interval time is less than 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life-threatening Patient&#xD;
&#xD;
          -  Patient can not do the Guide Line&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhang zhiguang, master</last_name>
    <role>Study Chair</role>
    <affiliation>UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zhang zhiguang, master</last_name>
    <phone>8602083870387</phone>
    <email>kouqiangzzg@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University</name>
      <address>
        <city>Guang Zhou</city>
        <state>Guangdong</state>
        <zip>510055</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhang zhiguang, master</last_name>
      <phone>8602083870387</phone>
      <email>kouqiangzzg@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Zhang zhiguang, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>May 19, 2015</last_update_submitted>
  <last_update_submitted_qc>May 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>zhang zhiguang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>mandible</keyword>
  <keyword>condylar fracture</keyword>
  <keyword>conservative treatment</keyword>
  <keyword>functional treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT02237040
org study id: SYSU-Clinical Treatment
nct id: NCT02237040
lead sponsor: 
has dmc: Yes
This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar
      fractures in pediatrics treated simply with a mandibular manipulation technique accompanied
      by mouth opening training.
There is a consensus on nonsurgical approach is a priority for paediatric condylar fractures,
      but a recognized nonsurgical method for treating children with condylar fractures is still a
      highly debated theme. The purpose of this study is to investigate the effect of a new
      nonsurgical method simply using a mandibular manipulation technique and mouth opening
      training in managing children with condylar fractures.

      Spiral computed tomography (CT) or Cone beam computed tomography (CBCT) will be taken before
      treatment when the patients present to the department. Condylar fracture classification is
      defined according to SPIESSL & SCHROLL.

      These patients are then treated termly with a mandibular manipulation technique reported by
      Farrar, which is an effective treatment method to reset the physiological positional
      relationship between condyle and disc. Neither intermaxillary fixation nor guiding elastics
      will be used after hand manipulation. Then patients are told to persist in mouth opening
      training at home everyday. The mouth opening training is performed as follow: patients are
      told to try to close his mouth in intercuspal position at first, then open their mouth as
      wide as possible(the reference maximal mouth opening is as wide as the mouth opening after
      treatment in last time), then closed back to the intercuspal position again. Patients are
      recommended to follow up at every week at first two months, then every 2 weeks at third
      months, 6th months, 1 year after first treatment, then yearly afterward. The mandibular
      manipulation is performed at every follow-up. Meanwhile, the maximal mouth opening (MMO) is
      recorded before and after hand manipulation treatment. So do the occlusion status, deviation
      during opening, as well as subjective symptoms of temporomandibular joints. At first moth,
      3rd month, 6th month, 1 year, then every year after first treatment, CBCT is performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants with accepted anatomical and functional recovery
time frame: up to 1 year
description: "accepted anatomical and functional recover" was defined as follow:
the maximal mouth opening is more than 32 millimeter
the fractured condylar with complete remodeling
No joint pain, clicking of the TMJ, and opening deviation(Normal mandibular movement without pathologic deviation was defined as lateral sliding less than 5 millimeter out of the midline of face during opening), unacceptable malocclusion(accepted occlusion is defined as stable intercuspidation between dental arches), dietary limitation was detected.
arm group label: treatment group
arm group type: Experimental
description: Patients are treated with the mandibular manipulation technique termly and mouth opening training
intervention type: Procedure
intervention name: Mandibular manipulation technique
description: patients are treated with The mandibular manipulation technique reported by Farrar, which was an effective treatment method to reset the physiological positional relationship between condyle and disc.Then patients are told to persist in mouth opening training at home everyday. The mouth opening training is performed as follow: patients are told to try to close his mouth in intercuspal position at first, then open their mouth as wide as possible(the reference maximal mouth opening is as wide as the mouth opening after treatment in last time), then close back to the intercuspal position again.
arm group label: treatment group
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Years
healthy volunteers: No
last name: zhang zhiguang, master
role: Study Chair
affiliation: UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
last name: zhang zhiguang, master
phone: 8602083870387
email: kouqiangzzg@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: zhang zhiguang
investigator title: Professor
mesh term: Fractures, Bone