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/NCT05972538</url>
    </required_header>
    <id_info>
      <org_study_id>64312012023</org_study_id>
      <nct_id>NCT05972538</nct_id>
    </id_info>
    <brief_title>Clinical Performance and Stability of Different Types of Implant Supported Overdenture</brief_title>
    <official_title>Clinical Performance and Stability of Different Types of Implant Supported Overdenture</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>
        A Total number of 36 implants were installed in 6 patients having mandibular single denture.&#xD;
  &#xD;
        The patients were divided into two groups according to the definitive prosthesis.&#xD;
  &#xD;
        Group I received ball and socket retained mandibular implant overdenture while Group II&#xD;
        received cement retained implant supported fixed bridges.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Implant's stability, clinical performance (gingival index, pocket depth, plaque index and&#xD;
        bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days&#xD;
        after prosthesis delivery&#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>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>participants don't know which treatment type they received.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of change in implant stability</measure>
      <time_frame>on the 15th, 30th, 60th and 90th days of overdenture insertion</time_frame>
      <description>Assessment of implant stability by device ( Ostell device)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of change in implants clinical performance throughout the follow-up period.</measure>
      <time_frame>on the 15th, 30th, 60th and 90th days of over denture insertion.</time_frame>
      <description>Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of patient satisfaction</measure>
      <time_frame>on the 90th day of prosthesis delivery</time_frame>
      <description>A questionnaire was used to evaluate patient satisfaction</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">6</enrollment>
    <condition>Complete Edentulism</condition>
    <arm_group>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Osstell ( Osstell AB, Goteborg, Sweden).</intervention_name>
      <description>Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein</intervention_name>
      <description>Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
      <other_name>- Assessment of implants clinical performance</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>questionnaire for patient satisfaction</intervention_name>
      <description>A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  highly co-operative&#xD;
  &#xD;
            -  non-smoker&#xD;
  &#xD;
            -  systemically free from any chronic diseases&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  immunocompromised patients&#xD;
  &#xD;
            -  patients having knife edge, flat or flabby ridge,&#xD;
  &#xD;
            -  patients having T. M. J disorders&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Asmaa N. Elboraey, Asso, Prof</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>
          <state>Dokki</state>
          <zip>12622</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Asmaa Nabil Elboraey</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Implant stability</keyword>
    <keyword>Pocket depth</keyword>
    <keyword>Patient Satisfaction</keyword>
    <keyword>Overdentures</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/NCT05972538
  org study id: 64312012023
  nct id: NCT05972538
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A Total number of 36 implants were installed in 6 patients having mandibular single denture.
  
        The patients were divided into two groups according to the definitive prosthesis.
  
        Group I received ball and socket retained mandibular implant overdenture while Group II
        received cement retained implant supported fixed bridges.
  Implant's stability, clinical performance (gingival index, pocket depth, plaque index and
        bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days
        after prosthesis delivery
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: participants don't know which treatment type they received.
  measure: Assessment of change in implant stability
  time frame: on the 15th, 30th, 60th and 90th days of overdenture insertion
  description: Assessment of implant stability by device ( Ostell device)
  measure: Assessment of change in implants clinical performance throughout the follow-up period.
  time frame: on the 15th, 30th, 60th and 90th days of over denture insertion.
  description: Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.
  measure: Assessment of patient satisfaction
  time frame: on the 90th day of prosthesis delivery
  description: A questionnaire was used to evaluate patient satisfaction
  arm group label: Group I
  arm group type: Active Comparator
  description: patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.
  arm group label: Group II
  arm group type: Experimental
  description: patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.
  intervention type: Device
  intervention name: Osstell ( Osstell AB, Goteborg, Sweden).
  description: Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery
  arm group label: Group I
  arm group label: Group II
  intervention type: Device
  intervention name: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
  description: Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
  arm group label: Group I
  arm group label: Group II
  other name: - Assessment of implants clinical performance
  intervention type: Other
  intervention name: questionnaire for patient satisfaction
  description: A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.
  arm group label: Group I
  arm group label: Group II
  criteria: 
  gender: Male
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Asmaa N. Elboraey, Asso, Prof
  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: Asmaa Nabil Elboraey
  investigator title: Associate Professor