<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/NCT03006757</url>
  </required_header>
  <id_info>
    <org_study_id>900</org_study_id>
    <nct_id>NCT03006757</nct_id>
  </id_info>
  <brief_title>Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic</brief_title>
  <official_title>Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>emad gamal ismail</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>
      The purpose of this study is to compare the effect of rapid heat cured acrylic resin material&#xD;
      with titanium dioxide nanoparticles added to conventional acrylic resin material on the&#xD;
      biting force of the single maxillary complete denture .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bite force is one indicator of the functional state of the masticatory system that results&#xD;
      from the action of jaw elevator muscles modified by the craniomandibular biomechanics&#xD;
      .Determination of individual bite force level has been widely used in dentistry, mainly to&#xD;
      understand the mechanics of mastication for evaluation of the therapeutic effects of&#xD;
      prosthetic devices and to provide reference values for studies on the biomechanics of&#xD;
      prosthetic devices. In addition, bite force has been considered important in the diagnosis of&#xD;
      the disturbances of the stomatognathic system .&#xD;
&#xD;
      Twenty (20) single maxillary completely edentulous patients were selected from the&#xD;
      out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental&#xD;
      Medicine, Cairo University.&#xD;
&#xD;
      The primary outcome is to measure the biting force of single maxillary complete denture by I&#xD;
      Load star sensor .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2</enrollment>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>Column titanium dioxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient take titanium dioxide denture participants will receive titanium dioxide denture ( made from conventional acrylic resin modified by titanium dioxide nanoparticles ) for 1 month in the initial phase of the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>column placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient will take denture with conventional acrylic ( 20 minutes cure ) for 1 month in the initial phase</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>titanium dioxide denture base</intervention_name>
    <arm_group_label>Column titanium dioxide</arm_group_label>
    <arm_group_label>column placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  completely edentulous maxillary arch and full or partial dentate mandibular arch with&#xD;
             adequate inter arch space&#xD;
&#xD;
          -  edentuluos arches should be covered by firm healthy mucosa angle class 1&#xD;
             maxillomandibular relationship&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with bad habits&#xD;
&#xD;
          -  previous history of radiotherapy or chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>mahmoud adly radwan, master</last_name>
    <phone>00201009714746</phone>
    <phone_ext>cairo</phone_ext>
    <email>mahmoud_omega@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mahmoud adly radwan, bachelor</last_name>
    <phone>00201009714746</phone>
    <phone_ext>cairo</phone_ext>
    <email>mahmoud_omega@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mahmoud Adly</name>
      <address>
        <city>Giza</city>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mahmoudd 002 radwan, bachelor</last_name>
      <phone>00201009714746</phone>
      <phone_ext>002</phone_ext>
      <email>mahmoud_omega@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>emad 002 gamal, bachelor</last_name>
      <phone>01009714746</phone>
      <phone_ext>002</phone_ext>
      <email>mahmoud_omega@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>emad gamal ismail</investigator_full_name>
    <investigator_title>principal invistigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Titanium dioxide</mesh_term>
  </intervention_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/NCT03006757
org study id: 900
nct id: NCT03006757
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the effect of rapid heat cured acrylic resin material
      with titanium dioxide nanoparticles added to conventional acrylic resin material on the
      biting force of the single maxillary complete denture .
Bite force is one indicator of the functional state of the masticatory system that results
      from the action of jaw elevator muscles modified by the craniomandibular biomechanics
      .Determination of individual bite force level has been widely used in dentistry, mainly to
      understand the mechanics of mastication for evaluation of the therapeutic effects of
      prosthetic devices and to provide reference values for studies on the biomechanics of
      prosthetic devices. In addition, bite force has been considered important in the diagnosis of
      the disturbances of the stomatognathic system .

      Twenty (20) single maxillary completely edentulous patients were selected from the
      out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental
      Medicine, Cairo University.

      The primary outcome is to measure the biting force of single maxillary complete denture by I
      Load star sensor .
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor
time frame: 3 months
arm group label: Column titanium dioxide
arm group type: Experimental
description: patient take titanium dioxide denture participants will receive titanium dioxide denture ( made from conventional acrylic resin modified by titanium dioxide nanoparticles ) for 1 month in the initial phase of the trial.
arm group label: column placebo
arm group type: Experimental
description: patient will take denture with conventional acrylic ( 20 minutes cure ) for 1 month in the initial phase
intervention type: Other
intervention name: titanium dioxide denture base
arm group label: Column titanium dioxide
arm group label: column placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mahmoud adly radwan, master
phone: 00201009714746
phone ext: cairo
email: mahmoud_omega@yahoo.com
last name: mahmoud adly radwan, bachelor
phone: 00201009714746
phone ext: cairo
email: mahmoud_omega@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: emad gamal ismail
investigator title: principal invistigator
mesh term: Titanium dioxide