<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/NCT03814070</url>
  </required_header>
  <id_info>
    <org_study_id>Nermeen Ahmed Hassan</org_study_id>
    <nct_id>NCT03814070</nct_id>
  </id_info>
  <brief_title>Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations</brief_title>
  <official_title>Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nermeen Ahmed Hassan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In immediate loading of implants of completely edentulous patients, the most common&#xD;
      post-surgical complication following the surgery noted in the dental literature is fracture&#xD;
      of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures&#xD;
      occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity&#xD;
      to withstand extended periods of heavy occlusal use.&#xD;
&#xD;
      Fractures of full arch provisional restorations during healing are concerning, because they&#xD;
      eliminate cross-arch stabilization and disrupt stress distribution patterns which might&#xD;
      jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it&#xD;
      is important to look for another material that has higher rigidity than PMMA and can&#xD;
      withstand masticatory forces for extended periods without fractures or load concentration on&#xD;
      the implants during the osseointegration period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</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>Prosthesis survival</measure>
    <time_frame>4 months</time_frame>
    <description>Clinical evaluation of any fracture in the prosthesis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant survival</measure>
    <time_frame>4 months</time_frame>
    <description>Clinical evaluation of implant loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant crestal bone loss during healing</measure>
    <time_frame>4 months</time_frame>
    <description>Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Completely Edentulous Patients</condition>
  <arm_group>
    <arm_group_label>Non-reinforced full arch acrylic restorations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>full arch acrylic restorations with fiber-reinforced framework</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fiber-reinforced framework</intervention_name>
    <description>Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations</description>
    <arm_group_label>full arch acrylic restorations with fiber-reinforced framework</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No framework</intervention_name>
    <description>Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.</description>
    <arm_group_label>Non-reinforced full arch acrylic restorations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completely edentulous patients.&#xD;
&#xD;
          -  Patients with proper amount of attached gingiva (≥2 mm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having a medical condition that absolutely contraindicates implant placement.&#xD;
&#xD;
          -  Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin&#xD;
             (HbA1c). (greater than 6.4 percent)&#xD;
&#xD;
          -  Potentially uncooperative patients who are not willing to go through the proposed&#xD;
             interventions.&#xD;
&#xD;
          -  Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).&#xD;
&#xD;
          -  Patients with history of bruxism&#xD;
&#xD;
          -  If insertion torque for the implants is less than 35 Ncm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nermeen Ahmed Hassan</investigator_full_name>
    <investigator_title>PhD candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</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/NCT03814070
org study id: Nermeen Ahmed Hassan
nct id: NCT03814070
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In immediate loading of implants of completely edentulous patients, the most common
      post-surgical complication following the surgery noted in the dental literature is fracture
      of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures
      occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity
      to withstand extended periods of heavy occlusal use.

      Fractures of full arch provisional restorations during healing are concerning, because they
      eliminate cross-arch stabilization and disrupt stress distribution patterns which might
      jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it
      is important to look for another material that has higher rigidity than PMMA and can
      withstand masticatory forces for extended periods without fractures or load concentration on
      the implants during the osseointegration period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prosthesis survival
time frame: 4 months
description: Clinical evaluation of any fracture in the prosthesis
measure: Implant survival
time frame: 4 months
description: Clinical evaluation of implant loss
measure: Peri-implant crestal bone loss during healing
time frame: 4 months
description: Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters
arm group label: Non-reinforced full arch acrylic restorations
arm group type: Active Comparator
arm group label: full arch acrylic restorations with fiber-reinforced framework
arm group type: Experimental
intervention type: Procedure
intervention name: Fiber-reinforced framework
description: Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations
arm group label: full arch acrylic restorations with fiber-reinforced framework
intervention type: Procedure
intervention name: No framework
description: Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.
arm group label: Non-reinforced full arch acrylic restorations
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Nermeen Ahmed Hassan
investigator title: PhD candidate
mesh term: Mouth, Edentulous