<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/NCT02996123</url>
  </required_header>
  <id_info>
    <org_study_id>EKF 54324</org_study_id>
    <nct_id>NCT02996123</nct_id>
  </id_info>
  <brief_title>Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases</brief_title>
  <official_title>Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases: A Randomized Controlled 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      measuring difference in biting force between (computer aided design/computer aided&#xD;
      manufacturing) maxillary dentures and conventional ones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      measuring difference in biting force using i-load device with followup period of 6 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases</measure>
    <time_frame>6 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Bites, Human</condition>
  <arm_group>
    <arm_group_label>cad/cam maxillary dentures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single maxillary dentures fabricated by cad/cam method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional dentures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>heat cured single maxillary dentures</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cad/cam maxillary dentures</intervention_name>
    <description>patients wearing cad/cam designed and milled dentures</description>
    <arm_group_label>cad/cam maxillary dentures</arm_group_label>
    <arm_group_label>conventional dentures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a&#xD;
             partially edentulous ridge.&#xD;
&#xD;
          2. Mean age of 50-75 years of age.&#xD;
&#xD;
          3. The edentulous ridges should be covered by firm healthy mucosa.&#xD;
&#xD;
          4. Systemically free; no history of diabetes, chemotherapy, and radiotherapy.&#xD;
&#xD;
          5. Co-operative patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with severely resorbed maxillary ridge&#xD;
&#xD;
          2. Previous history of radiotherapy or chemotherapy.&#xD;
&#xD;
          3. Patients with xerostomia&#xD;
&#xD;
          4. Patients with neuromuscular and hormonal disorders&#xD;
&#xD;
          5. Patients with severe bony or soft tissue undercuts&#xD;
&#xD;
          6. Patients with large tongue&#xD;
&#xD;
          7. Patients with limited mouth opening&#xD;
&#xD;
          8. Patients with known history of allergy, especially to acrylic resin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Cairo Governorate</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Erfan Gamal El Dein</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bites, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>charts with measurements and readings collected will be recorded and available</ipd_description>
  </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/NCT02996123
org study id: EKF 54324
nct id: NCT02996123
lead sponsor: 
has dmc: Yes
measuring difference in biting force between (computer aided design/computer aided
      manufacturing) maxillary dentures and conventional ones.
measuring difference in biting force using i-load device with followup period of 6 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases
time frame: 6 month
arm group label: cad/cam maxillary dentures
arm group type: Experimental
description: single maxillary dentures fabricated by cad/cam method
arm group label: conventional dentures
arm group type: Active Comparator
description: heat cured single maxillary dentures
intervention type: Other
intervention name: cad/cam maxillary dentures
description: patients wearing cad/cam designed and milled dentures
arm group label: cad/cam maxillary dentures
arm group label: conventional dentures
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Erfan Gamal El Dein
investigator title: Dr
mesh term: Bites, Human
sharing ipd: Yes
ipd description: charts with measurements and readings collected will be recorded and available