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/NCT06034132</url>
    </required_header>
    <id_info>
      <org_study_id>Implants_2022_MP8</org_study_id>
      <nct_id>NCT06034132</nct_id>
    </id_info>
    <brief_title>Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid</brief_title>
    <official_title>Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Numerous materials are nowadays used in the fabrication of healing abutments to be used for&#xD;
        dental implants. soft tissue response to different healing abutment materials is still to be&#xD;
        unraveled. the Aim of this study is to compare the soft tissue response to titanium stock&#xD;
        healing abutments to customized composite healing abutments through assessing the level of&#xD;
        matrix metalloproteinase-8 in the peri-implant crevicular fluid&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in MMP8 levels</measure>
      <time_frame>at 2 weeks and 4 weeks</time_frame>
      <description>Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in gingival condition</measure>
      <time_frame>at 2 weeks and 4 weeks</time_frame>
      <description>Modified gingival index was used to assess gingival condition The MGI uses a rating score between 0 and 4 0 = absence of inflammation&#xD;
  = mild inflammation&#xD;
  = mild inflammation&#xD;
  = moderate inflmmation&#xD;
  = severe inflammation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in gingival bleeding</measure>
      <time_frame>at 2 weeks and 4 weeks</time_frame>
      <description>Bleeding index will be recorded as present or absent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in plaque accumulation</measure>
      <time_frame>at 2 weeks and 4 weeks</time_frame>
      <description>Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.&#xD;
  Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.&#xD;
  Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Dental Implants</condition>
    <arm_group>
      <arm_group_label>Test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stock healing abutments</intervention_name>
      <description>2ND stage surgery will be performed and stock healing abutment were placed</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Compoiste healing abutments</intervention_name>
      <description>2ND stage surgery will be performed and composite healing abutment were placed</description>
      <arm_group_label>Test group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with no systemic and/or oral health disease&#xD;
  &#xD;
            -  absence of any lesions in the oral cavity&#xD;
  &#xD;
            -  wide band of keratinized tissue more than 1mm at implant site&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  smoking more than 20 cigarettes per day&#xD;
  &#xD;
            -  localized radiation therapy of the oral cavity,&#xD;
  &#xD;
            -  antitumor chemotherapy, liver diseases, blood diseases, kidney diseases,&#xD;
               immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory&#xD;
               and autoimmune diseases of the oral cavity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alexandria Faculty of Dentistry</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
      <investigator_title>Assistant lecturer of DPH and Clinical statistician</investigator_title>
    </responsible_party>
    <!-- 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/NCT06034132
  org study id: Implants_2022_MP8
  nct id: NCT06034132
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Numerous materials are nowadays used in the fabrication of healing abutments to be used for
        dental implants. soft tissue response to different healing abutment materials is still to be
        unraveled. the Aim of this study is to compare the soft tissue response to titanium stock
        healing abutments to customized composite healing abutments through assessing the level of
        matrix metalloproteinase-8 in the peri-implant crevicular fluid
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in MMP8 levels
  time frame: at 2 weeks and 4 weeks
  description: Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit
  measure: Change in gingival condition
  time frame: at 2 weeks and 4 weeks
  description: Modified gingival index was used to assess gingival condition The MGI uses a rating score between 0 and 4 0 = absence of inflammation
  = mild inflammation
  = mild inflammation
  = moderate inflmmation
  = severe inflammation
  measure: Change in gingival bleeding
  time frame: at 2 weeks and 4 weeks
  description: Bleeding index will be recorded as present or absent
  measure: Change in plaque accumulation
  time frame: at 2 weeks and 4 weeks
  description: Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
  Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
  Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
  arm group label: Test group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Stock healing abutments
  description: 2ND stage surgery will be performed and stock healing abutment were placed
  arm group label: Control group
  intervention type: Other
  intervention name: Compoiste healing abutments
  description: 2ND stage surgery will be performed and composite healing abutment were placed
  arm group label: Test group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Hams Hamed Abdelrahman
  investigator title: Assistant lecturer of DPH and Clinical statistician