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/NCT05974215</url>
    </required_header>
    <id_info>
      <org_study_id>1431022023</org_study_id>
      <nct_id>NCT05974215</nct_id>
    </id_info>
    <brief_title>Peri Implant Marginal Bone Height and Bone Density</brief_title>
    <official_title>Peri Implant Marginal Bone Height and Density Supporting Different Prosthesis Restoring Single Edentulous Mandible</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Menatallah Mohamed Elhotieby</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 the effect of mandibular implant supported removable overdenture&#xD;
        on bone height and density and compare it with implant supported fixed overdenture in single&#xD;
        mandibular overdenture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study 10 patients will be selected following inclusion and exclusion criteria. In&#xD;
        each group 5 patients (each patient will receive 6 implants) will be divided randomly into&#xD;
        two groups.&#xD;
  &#xD;
        Group I patients will receive mandibular implant supported removable overdenture, while Group&#xD;
        II will receive mandibular implant supported fixed overdenture.&#xD;
  &#xD;
        All patients will be given the usual home care instructions about wearing and caring of&#xD;
        dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with&#xD;
        denture brush and mild soap will be required. Measurements of Bone height and Bone density&#xD;
        will be obtained by using Cone Beam Computed Tomography (CBCT).&#xD;
  &#xD;
        Measurements will be obtained at denture insertion, after 1 month and after 3 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">July 5, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 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>
      <intervention_model_description>group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>each patient was not informed about type of received restoration</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>assessment of change of bone height around dental implants</measure>
      <time_frame>on the first day, on 30th day, 90th day</time_frame>
      <description>bone height was assessed by cone beam computed tomography</description>
    </primary_outcome>
    <primary_outcome>
      <measure>assessment of change of bone density around dental implants</measure>
      <time_frame>on the first day, on 30th day, 90th day</time_frame>
      <description>bone density was assessed by cone beam computed tomography</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Implant Site Reaction</condition>
    <arm_group>
      <arm_group_label>group 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients received mandibular implant supported removable overdenture</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients received mandibular implant supported fixed overdenture</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>assessment of change in bone height by cone beam computed tomography</intervention_name>
      <description>bone height was measured at 1 ,30 ,90 days after denture insertion</description>
      <arm_group_label>group 1</arm_group_label>
      <arm_group_label>group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-smoker Patients&#xD;
  &#xD;
            -  Highly cooperative and motivated patients.&#xD;
  &#xD;
            -  Patients Systemically free from any immunosuppressive diseases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetic, hypertensive, cancer patients.&#xD;
  &#xD;
            -  Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and&#xD;
               foreign bodies.&#xD;
  &#xD;
            -  Patients with temporo-mandibular joint disorders and bad oral habits.&#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>Cairo</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>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>National Research Centre, Egypt</investigator_affiliation>
      <investigator_full_name>Menatallah Mohamed Elhotieby</investigator_full_name>
      <investigator_title>researcher fixed and removable prosthodontics</investigator_title>
    </responsible_party>
    <keyword>Bone height</keyword>
    <keyword>Bone density</keyword>
    <keyword>Implant supported</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/NCT05974215
  org study id: 1431022023
  nct id: NCT05974215
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the effect of mandibular implant supported removable overdenture
        on bone height and density and compare it with implant supported fixed overdenture in single
        mandibular overdenture.
  In this study 10 patients will be selected following inclusion and exclusion criteria. In
        each group 5 patients (each patient will receive 6 implants) will be divided randomly into
        two groups.
  
        Group I patients will receive mandibular implant supported removable overdenture, while Group
        II will receive mandibular implant supported fixed overdenture.
  
        All patients will be given the usual home care instructions about wearing and caring of
        dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with
        denture brush and mild soap will be required. Measurements of Bone height and Bone density
        will be obtained by using Cone Beam Computed Tomography (CBCT).
  
        Measurements will be obtained at denture insertion, after 1 month and after 3 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: each patient was not informed about type of received restoration
  measure: assessment of change of bone height around dental implants
  time frame: on the first day, on 30th day, 90th day
  description: bone height was assessed by cone beam computed tomography
  measure: assessment of change of bone density around dental implants
  time frame: on the first day, on 30th day, 90th day
  description: bone density was assessed by cone beam computed tomography
  arm group label: group 1
  arm group type: Active Comparator
  description: patients received mandibular implant supported removable overdenture
  arm group label: group 2
  arm group type: Active Comparator
  description: patients received mandibular implant supported fixed overdenture
  intervention type: Device
  intervention name: assessment of change in bone height by cone beam computed tomography
  description: bone height was measured at 1 ,30 ,90 days after denture insertion
  arm group label: group 1
  arm group label: group 2
  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: Sponsor-Investigator
  investigator affiliation: National Research Centre, Egypt
  investigator full name: Menatallah Mohamed Elhotieby
  investigator title: researcher fixed and removable prosthodontics