<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/NCT02992379</url>
  </required_header>
  <id_info>
    <org_study_id>cairo ss-ps</org_study_id>
    <nct_id>NCT02992379</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint</brief_title>
  <official_title>Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint as Treatment for TMJ Anterior Disc Displacement Without Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw&#xD;
      exercise together with stabilizing splints for treatment of TMJ anterior disc displacement&#xD;
      without reduction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw&#xD;
      exercise together with stabilizing splints for treatment of TMJ anterior disc displacement&#xD;
      without reduction&#xD;
&#xD;
      PICO:&#xD;
&#xD;
      Population (P): Patients with symptomatic anterior disc displacement without reduction.&#xD;
&#xD;
      Intervention (I): pivot splint.&#xD;
&#xD;
      Comparator (C): stabilizing repositioning splint (ARS).&#xD;
&#xD;
      Outcome (O):&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      Patients' subjective pain experience. Each patient will be asked to rate his or her current&#xD;
      and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and&#xD;
      ten corresponds to the worst pain that the patient ever had.&#xD;
&#xD;
      Secondary outcome:&#xD;
&#xD;
        1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the&#xD;
           distance in mm between the incisal edges of the upper and lower central incisors using a&#xD;
           ruler.&#xD;
&#xD;
        2. Lateral excursion. Assessment of lateral excursion will be performed by measuring the&#xD;
           distance in mm between midline of upper and lower jaws&#xD;
&#xD;
        3. Protrusion. distance in mm from the incisal edge of the maxillary central incisor to the&#xD;
           incisor edge of the mandibular incisor will measured in the maximum protruded position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' subjective pain experience (numerical rating scale)</measure>
    <time_frame>6 months</time_frame>
    <description>Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum mouth opening (Unit: mm)</measure>
    <time_frame>6 months</time_frame>
    <description>measuring the distance between the incisal edges of the upper and lower central incisors using a ruler. Unit: mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lateral excursion (Unit: mm)</measure>
    <time_frame>6 months</time_frame>
    <description>measuring the distance between midline of upper and lower jaws. Unit: mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protrusion (distance in mm)</measure>
    <time_frame>6 months</time_frame>
    <description>The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>TMJ Disc Disorder</condition>
  <arm_group>
    <arm_group_label>stabilizing splint</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Comparator: stabilizing splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pivot splint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: pivot splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks.&#xD;
Other Names: PS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pivot splint</intervention_name>
    <description>A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of selfcuring acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe.</description>
    <arm_group_label>pivot splint</arm_group_label>
    <arm_group_label>stabilizing splint</arm_group_label>
    <other_name>PS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stabilizing splint</intervention_name>
    <description>A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint</description>
    <arm_group_label>pivot splint</arm_group_label>
    <arm_group_label>stabilizing splint</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient from 15 to 50 years old&#xD;
&#xD;
          -  Report of pain in preauricular region worsened by functional activities, such as&#xD;
             chewing and talking&#xD;
&#xD;
          -  Presence of disc displacement with reduction and joint clicking&#xD;
&#xD;
          -  Positive diagnosis of unilateral or bilateral anterior disc displacement with&#xD;
             reduction by means of magnetic resonance imaging (MRI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with systemic diseases that can affect TMJ&#xD;
&#xD;
          -  History of TMJ surgery&#xD;
&#xD;
          -  Individuals with osteoarthritis&#xD;
&#xD;
          -  Individuals under TMD management&#xD;
&#xD;
          -  Individuals wearing full or partial dentures&#xD;
&#xD;
          -  Reducing dislocations of the articular disc&#xD;
&#xD;
          -  Consequences of condyle fractures and/or fracture of another maxillofacial zone&#xD;
&#xD;
          -  In therapy for the same pathologies&#xD;
&#xD;
          -  Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis,&#xD;
             psoriasis arthritis)&#xD;
&#xD;
          -  Individuals with a recent history of trauma in the face and/or neck area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia Galal, Ass.prof</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hesham M safa, master</last_name>
    <phone>01001720677</phone>
    <email>Dr.hesham_dent@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omniya Abdelaziz, lecturer</last_name>
    <phone>01001203583</phone>
    <email>omniya.abdelaziz@gmail.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Ebrahim S, Montoya L, Busse JW, Carrasco-Labra A, Guyatt GH; Medically Unexplained Syndromes Research Group. The effectiveness of splint therapy in patients with temporomandibular disorders: a systematic review and meta-analysis. J Am Dent Assoc. 2012 Aug;143(8):847-57. doi: 10.14219/jada.archive.2012.0289.</citation>
    <PMID>22855899</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 10, 2016</last_update_submitted>
  <last_update_submitted_qc>December 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hesham Mohamed mohamed elsayed safa</investigator_full_name>
    <investigator_title>Resident at National Cancer Institute</investigator_title>
  </responsible_party>
  <keyword>Anterior disc displacement</keyword>
  <keyword>Stabilizing splint</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02992379
org study id: cairo ss-ps
nct id: NCT02992379
lead sponsor: 
has dmc: No
To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw
      exercise together with stabilizing splints for treatment of TMJ anterior disc displacement
      without reduction
To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw
      exercise together with stabilizing splints for treatment of TMJ anterior disc displacement
      without reduction

      PICO:

      Population (P): Patients with symptomatic anterior disc displacement without reduction.

      Intervention (I): pivot splint.

      Comparator (C): stabilizing repositioning splint (ARS).

      Outcome (O):

      Primary outcome:

      Patients' subjective pain experience. Each patient will be asked to rate his or her current
      and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and
      ten corresponds to the worst pain that the patient ever had.

      Secondary outcome:

        1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the
           distance in mm between the incisal edges of the upper and lower central incisors using a
           ruler.

        2. Lateral excursion. Assessment of lateral excursion will be performed by measuring the
           distance in mm between midline of upper and lower jaws

        3. Protrusion. distance in mm from the incisal edge of the maxillary central incisor to the
           incisor edge of the mandibular incisor will measured in the maximum protruded position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients' subjective pain experience (numerical rating scale)
time frame: 6 months
description: Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.
measure: Maximum mouth opening (Unit: mm)
time frame: 6 months
description: measuring the distance between the incisal edges of the upper and lower central incisors using a ruler. Unit: mm
measure: Lateral excursion (Unit: mm)
time frame: 6 months
description: measuring the distance between midline of upper and lower jaws. Unit: mm
measure: Protrusion (distance in mm)
time frame: 6 months
description: The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.
arm group label: stabilizing splint
arm group type: Active Comparator
description: Active Comparator: stabilizing splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint
arm group label: pivot splint
arm group type: Experimental
description: Experimental: pivot splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks.
Other Names: PS
intervention type: Device
intervention name: pivot splint
description: A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of selfcuring acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe.
arm group label: pivot splint
arm group label: stabilizing splint
other name: PS
intervention type: Device
intervention name: stabilizing splint
description: A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint
arm group label: pivot splint
arm group label: stabilizing splint
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nadia Galal, Ass.prof
role: Study Director
affiliation: Cairo University
last name: hesham M safa, master
phone: 01001720677
email: Dr.hesham_dent@hotmail.com
last name: Omniya Abdelaziz, lecturer
phone: 01001203583
email: omniya.abdelaziz@gmail.com
citation: Ebrahim S, Montoya L, Busse JW, Carrasco-Labra A, Guyatt GH; Medically Unexplained Syndromes Research Group. The effectiveness of splint therapy in patients with temporomandibular disorders: a systematic review and meta-analysis. J Am Dent Assoc. 2012 Aug;143(8):847-57. doi: 10.14219/jada.archive.2012.0289.
PMID: 22855899
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hesham Mohamed mohamed elsayed safa
investigator title: Resident at National Cancer Institute
sharing ipd: No