<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/NCT04455672</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2020-06-29</org_study_id>
    <nct_id>NCT04455672</nct_id>
  </id_info>
  <brief_title>A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder</brief_title>
  <official_title>A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder (A Randomized Cross Over Clinical Trial)</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>Yes</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>
      • to compare the relief of pain for patients with anterior disc displacement with reduction&#xD;
      between two groups; in the first group a digitally formed stabilizing splint followed by an&#xD;
      anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints&#xD;
      followed by a stabilizing splints&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 26, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 26, 2021</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>pain relief</measure>
    <time_frame>6 months</time_frame>
    <description>questionnaire will be used to evaluate the pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>splints</intervention_name>
    <description>Scaning of the maxillary and mandibular cast in the centric relation.&#xD;
The CAD/ CAM splints will be designed using Exocad s.&#xD;
The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth.&#xD;
The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp.&#xD;
Both splints will be printed using Dent2 3D printer and then cured using Dentcure.&#xD;
All patient will be asked to wear their spints during sleeping only.&#xD;
In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months .</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • TMDs according to the research diagnostic criteria (RDC)8 which include: i. Painful&#xD;
             TMJ audible and palpable click unilateral or bilateral ii. Presence of clicking during&#xD;
             opening. iii. TMJ tenderness.&#xD;
&#xD;
               -  Fully dentate patients without any malocclusion (natural or restored by fixed&#xD;
                  prothesis) and good oral hygiene.&#xD;
&#xD;
               -  Co-operative patient that should show motivation to follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis,&#xD;
             osteoarthrosis, Myasthenia Gravis and fibromyalgia.&#xD;
&#xD;
               -  Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were&#xD;
                  excluded because such drugs could influence the results.&#xD;
&#xD;
               -  Patients with removable dental prosthesis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>mostafa mohamed sobhy</investigator_full_name>
    <investigator_title>the principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04455672
org study id: CEBD-CU-2020-06-29
nct id: NCT04455672
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
• to compare the relief of pain for patients with anterior disc displacement with reduction
      between two groups; in the first group a digitally formed stabilizing splint followed by an
      anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints
      followed by a stabilizing splints
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain relief
time frame: 6 months
description: questionnaire will be used to evaluate the pain
arm group label: interventional group
arm group type: Experimental
description: patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)
arm group label: control group
arm group type: Active Comparator
description: patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)
intervention type: Device
intervention name: splints
description: Scaning of the maxillary and mandibular cast in the centric relation.
The CAD/ CAM splints will be designed using Exocad s.
The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth.
The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp.
Both splints will be printed using Dent2 3D printer and then cured using Dentcure.
All patient will be asked to wear their spints during sleeping only.
In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months .
arm group label: control group
arm group label: interventional group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: mostafa mohamed sobhy
investigator title: the principle investigator
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome