xml: <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/NCT05999760</url>
    </required_header>
    <id_info>
      <org_study_id>Elhotieby.M</org_study_id>
      <nct_id>NCT05999760</nct_id>
    </id_info>
    <brief_title>Retention, Chewing Efficiency and Masticatory Performance of Partial Dentures Opposing Implant Retained Prosthesis.</brief_title>
    <official_title>Retention, Chewing Efficiency and Masticatory Performance of Maxillary Flexible Versus Computer Aided Design/Computer Aided Manufacture(CAD/CAM) Partial Dentures Opposing Fixed Implant Retained Prosthesis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Research Centre, Egypt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Research Centre, Egypt</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>
        This study aims to evaluate retention ,chewing efficiency and masticatory performance of&#xD;
        flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        in this study 22 patients will be selected following inclusion and exclusion criteria. The&#xD;
        patients will be divided randomly into two groups.&#xD;
  &#xD;
        Group I patients will receive Versacrylic removable partial denture. group II patients will&#xD;
        receive CAD/CAM removable partial denture all patients will be given the home care&#xD;
        instructions at night and brush cleaning of the dentures.&#xD;
  &#xD;
        Measurements of retention using universal testing machine, masticatory performance using&#xD;
        T-scan III computerized system and chewing efficiency using chewing function questionnaire&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 15, 2022</start_date>
    <completion_date type="Actual">January 20, 2023</completion_date>
    <primary_completion_date type="Actual">January 15, 2023</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>
      <masking_description>each patient was not informed about material of received prosthesis</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>evaluation of change of retention of versacrylic and CAD/CAM partial denture</measure>
      <time_frame>on day 1 ,1 month and 2months of prosthesis delivery</time_frame>
      <description>measurement of retention of partial dentures made of Versacryle and CAD/CAM technology</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture</measure>
      <time_frame>on day 1 ,1 month and 2months of prosthesis delivery</time_frame>
      <description>measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture</measure>
      <time_frame>on day 1,1 month and 2months of prosthesis delivery</time_frame>
      <description>measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">22</enrollment>
    <condition>Implant Site Reaction</condition>
    <condition>Implant Complication</condition>
    <arm_group>
      <arm_group_label>Group I (patients received Versacryle removable partial denture)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients having Kennedy class I received maxillary Versacryle removable partial denture</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II (patients received CAD/CAM fabricated removable partial denture)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients having Kennedy class I received maxillary CAD/CAM fabricated removable partial denture</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge</intervention_name>
      <description>Evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.</description>
      <arm_group_label>Group I (patients received Versacryle removable partial denture)</arm_group_label>
      <arm_group_label>Group II (patients received CAD/CAM fabricated removable partial denture)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>chewing efficiency by electromyograph(E.M.G)</intervention_name>
      <description>Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.</description>
      <arm_group_label>Group I (patients received Versacryle removable partial denture)</arm_group_label>
      <arm_group_label>Group II (patients received CAD/CAM fabricated removable partial denture)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>masticatory performance(questionnaire)</intervention_name>
      <description>Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery.</description>
      <arm_group_label>Group I (patients received Versacryle removable partial denture)</arm_group_label>
      <arm_group_label>Group II (patients received CAD/CAM fabricated removable partial denture)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-smoker male Patients&#xD;
  &#xD;
            -  Age ranging from 40-50 years.&#xD;
  &#xD;
            -  Highly cooperative and motivated patients.&#xD;
  &#xD;
            -  Patients Systemically free from any immunosuppressive diseases.&#xD;
  &#xD;
            -  Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.&#xD;
  &#xD;
            -  Patients not receiving any Radiotherapy or chemotherapy treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Female patients&#xD;
  &#xD;
            -  Smoker patients.&#xD;
  &#xD;
            -  Age exceeding 50 years&#xD;
  &#xD;
            -  Uncooperative and unmotivated patients.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Menatallah Elhotieby, Researcher</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Research Centre, Egypt</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Research Centre</name>
        <address>
          <city>Giza</city>
          <zip>12622</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Research Centre, Egypt</investigator_affiliation>
      <investigator_full_name>Menatallah Mohamed Elhotieby</investigator_full_name>
      <investigator_title>Principle investigator Researcher fixed and removable prosthodontics</investigator_title>
    </responsible_party>
    <keyword>Retention</keyword>
    <keyword>Chewing efficiency</keyword>
    <keyword>Removable Prosthodontics</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999760
  org study id: Elhotieby.M
  nct id: NCT05999760
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate retention ,chewing efficiency and masticatory performance of
        flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.
  in this study 22 patients will be selected following inclusion and exclusion criteria. The
        patients will be divided randomly into two groups.
  
        Group I patients will receive Versacrylic removable partial denture. group II patients will
        receive CAD/CAM removable partial denture all patients will be given the home care
        instructions at night and brush cleaning of the dentures.
  
        Measurements of retention using universal testing machine, masticatory performance using
        T-scan III computerized system and chewing efficiency using chewing function questionnaire
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: each patient was not informed about material of received prosthesis
  measure: evaluation of change of retention of versacrylic and CAD/CAM partial denture
  time frame: on day 1 ,1 month and 2months of prosthesis delivery
  description: measurement of retention of partial dentures made of Versacryle and CAD/CAM technology
  measure: evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture
  time frame: on day 1 ,1 month and 2months of prosthesis delivery
  description: measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology
  measure: evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture
  time frame: on day 1,1 month and 2months of prosthesis delivery
  description: measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology
  arm group label: Group I (patients received Versacryle removable partial denture)
  arm group type: Active Comparator
  description: patients having Kennedy class I received maxillary Versacryle removable partial denture
  arm group label: Group II (patients received CAD/CAM fabricated removable partial denture)
  arm group type: Active Comparator
  description: patients having Kennedy class I received maxillary CAD/CAM fabricated removable partial denture
  intervention type: Device
  intervention name: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge
  description: Evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.
  arm group label: Group I (patients received Versacryle removable partial denture)
  arm group label: Group II (patients received CAD/CAM fabricated removable partial denture)
  intervention type: Device
  intervention name: chewing efficiency by electromyograph(E.M.G)
  description: Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.
  arm group label: Group I (patients received Versacryle removable partial denture)
  arm group label: Group II (patients received CAD/CAM fabricated removable partial denture)
  intervention type: Other
  intervention name: masticatory performance(questionnaire)
  description: Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery.
  arm group label: Group I (patients received Versacryle removable partial denture)
  arm group label: Group II (patients received CAD/CAM fabricated removable partial denture)
  criteria: 
  gender: Male
  minimum age: 40 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Menatallah Elhotieby, Researcher
  role: Principal Investigator
  affiliation: National Research Centre, Egypt
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: National Research Centre, Egypt
  investigator full name: Menatallah Mohamed Elhotieby
  investigator title: Principle investigator Researcher fixed and removable prosthodontics