<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/NCT03792425</url>
  </required_header>
  <id_info>
    <org_study_id>2121992</org_study_id>
    <nct_id>NCT03792425</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Pink Esthetic Score</brief_title>
  <official_title>Clinical Evaluation of Pink Esthetic Score Following Delayed Implant Placement With Connective Tissue Graft With and Without Temporization in the Maxillary Esthetic Zone With Thin Gingival Biotype</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Clinical evaluation of pink esthetic score in delayed implants in thin gingival biotype with&#xD;
      and without temporization in the esthetic zone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical evaluation of the pink esthetic score with and withiut temporization in thin&#xD;
      gingival biotype in the maxillary esthetic zone with subepithelial connective tissue graft in&#xD;
      bith groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pink esthetic score</measure>
    <time_frame>1 year from the base line</time_frame>
    <description>Clinical assessment accotding to furhausser et al</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Thin Gingiva</condition>
  <arm_group>
    <arm_group_label>implant with immediate temporization</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Immediate nonfunctional loading</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed implant without temporization</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional loading protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Connective tissue graft and implant placement</intervention_name>
    <description>Augmenting soft tissue with connective tissue graft</description>
    <arm_group_label>Delayed implant without temporization</arm_group_label>
    <arm_group_label>implant with immediate temporization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with missing teeth in the maxillary esthetic zone with thin gingival biotype&#xD;
             and adequate arch space&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deficient ridge , crowns on the adjacent teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maha 1 Abd allah, Bch</last_name>
    <phone>01008585509</phone>
    <email>Mahafawzy212@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manal 1 Abdallah, Bsh</last_name>
    <phone>01007100388</phone>
    <email>Mahi.21@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Maha fawzy el sayed ali abd allah</investigator_full_name>
    <investigator_title>Teaching assistant at el Ahram canadian university</investigator_title>
  </responsible_party>
  <!-- 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/NCT03792425
org study id: 2121992
nct id: NCT03792425
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Clinical evaluation of pink esthetic score in delayed implants in thin gingival biotype with
      and without temporization in the esthetic zone
Clinical evaluation of the pink esthetic score with and withiut temporization in thin
      gingival biotype in the maxillary esthetic zone with subepithelial connective tissue graft in
      bith groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Pink esthetic score
time frame: 1 year from the base line
description: Clinical assessment accotding to furhausser et al
arm group label: implant with immediate temporization
arm group type: Other
description: Immediate nonfunctional loading
arm group label: Delayed implant without temporization
arm group type: Other
description: Conventional loading protocol
intervention type: Procedure
intervention name: Connective tissue graft and implant placement
description: Augmenting soft tissue with connective tissue graft
arm group label: Delayed implant without temporization
arm group label: implant with immediate temporization
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maha 1 Abd allah, Bch
phone: 01008585509
email: Mahafawzy212@gmail.com
last name: Manal 1 Abdallah, Bsh
phone: 01007100388
email: Mahi.21@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Maha fawzy el sayed ali abd allah
investigator title: Teaching assistant at el Ahram canadian university