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/NCT06040788</url>
    </required_header>
    <id_info>
      <org_study_id>IDCE.N5</org_study_id>
      <nct_id>NCT06040788</nct_id>
    </id_info>
    <brief_title>Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment</brief_title>
    <official_title>Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment. A 1-Year Randomized Clinical Trial</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>
        The goal of this clinical trial is to investigate the effect of different anatomical&#xD;
        variations in terms of root angulation, alveolar bone and basal bone morphology on soft and&#xD;
        hard tissue alterations in patients with non-restorable teeth in the inter-canine region&#xD;
        undergoing immediate implantation. The main question it aims to answer are:&#xD;
  &#xD;
          -  Will the amount of collapse be greater when the root is proclined or outside the bone&#xD;
             housing?&#xD;
  &#xD;
          -  Will no additional intervention be needed with immediate implants in the esthetic zone&#xD;
             if we have better anatomy that will help hinder the collapse? Participants will receive&#xD;
             immediate dental implants with customized healing abutments&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Amount of labiopalatal ridge collapse</measure>
      <time_frame>1 year</time_frame>
      <description>radiographic Labiopalatal ridge collapse via CBCT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Amount of bone labial to the implant</measure>
      <time_frame>1 year</time_frame>
      <description>Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amount of vertical crestal bone resorption in millimeters</measure>
      <time_frame>1 year</time_frame>
      <description>Vertical crestal bone changes via CBCT in mm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of change in buccal soft issue contour in mm3</measure>
      <time_frame>1 year</time_frame>
      <description>volumetric analysis of the amount of change in buccal soft issue contour in mm3</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of Mid facial recession in millimeters</measure>
      <time_frame>1 year</time_frame>
      <description>Mid facial recession in n millimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pink esthetic score</measure>
      <time_frame>1 year</time_frame>
      <description>1-14 scale</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Immediate Implant</condition>
    <condition>Esthetic Zone</condition>
    <condition>Customized Healing Abutment</condition>
    <condition>Tissue Collapse</condition>
    <condition>Tissue Dimensional Changes</condition>
    <arm_group>
      <arm_group_label>immediate implant placement with customized healing abutment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>immediate implant placement with customized healing abutment</intervention_name>
      <description>immediate implant placement with customized healing abutment</description>
      <arm_group_label>immediate implant placement with customized healing abutment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patient-related criteria:&#xD;
  &#xD;
            -  Adults at or above the age of 21.&#xD;
  &#xD;
            -  Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant&#xD;
               placing therapy.&#xD;
  &#xD;
            -  The failing tooth will have adjacent and opposing natural teeth.&#xD;
  &#xD;
            -  Sufficient mesial-distal and interocclusal space for placement of the implant and&#xD;
               definitive restoration.&#xD;
  &#xD;
            -  Able to tolerate surgical periodontal procedures.&#xD;
  &#xD;
            -  Good oral hygiene.&#xD;
  &#xD;
            -  Compliance with the maintenance program.&#xD;
  &#xD;
            -  Provide informed consent.&#xD;
  &#xD;
            -  Accepts the one-year follow-up period.&#xD;
  &#xD;
          Teeth related criteria:&#xD;
  &#xD;
            -  Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.&#xD;
  &#xD;
            -  Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.&#xD;
  &#xD;
            -  Sufficient apical bone to place an immediate implant with minimum primary stability of&#xD;
               30Ncm.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patients diagnosed with periodontal diseases.&#xD;
  &#xD;
            -  Current or previous smokers.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Patients with medical conditions that would compromise the surgical procedures;&#xD;
               uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of&#xD;
               osteoporosis.&#xD;
  &#xD;
            -  Patients with active infection related at the site of implant/bone graft placement.&#xD;
  &#xD;
            -  Patients with parafunctional habits&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Nesma Mohamed Fouad Shemais</investigator_full_name>
      <investigator_title>Lecturer in the department of Oral Medicine &amp; Periodontology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shock</mesh_term>
    </condition_browse>
    <!-- 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/NCT06040788
  org study id: IDCE.N5
  nct id: NCT06040788
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the effect of different anatomical
        variations in terms of root angulation, alveolar bone and basal bone morphology on soft and
        hard tissue alterations in patients with non-restorable teeth in the inter-canine region
        undergoing immediate implantation. The main question it aims to answer are:
  
          -  Will the amount of collapse be greater when the root is proclined or outside the bone
             housing?
  
          -  Will no additional intervention be needed with immediate implants in the esthetic zone
             if we have better anatomy that will help hinder the collapse? Participants will receive
             immediate dental implants with customized healing abutments
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Amount of labiopalatal ridge collapse
  time frame: 1 year
  description: radiographic Labiopalatal ridge collapse via CBCT
  measure: Amount of bone labial to the implant
  time frame: 1 year
  description: Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT
  measure: Amount of vertical crestal bone resorption in millimeters
  time frame: 1 year
  description: Vertical crestal bone changes via CBCT in mm
  measure: Amount of change in buccal soft issue contour in mm3
  time frame: 1 year
  description: volumetric analysis of the amount of change in buccal soft issue contour in mm3
  measure: amount of Mid facial recession in millimeters
  time frame: 1 year
  description: Mid facial recession in n millimeters
  measure: Pink esthetic score
  time frame: 1 year
  description: 1-14 scale
  arm group label: immediate implant placement with customized healing abutment
  arm group type: Experimental
  intervention type: Procedure
  intervention name: immediate implant placement with customized healing abutment
  description: immediate implant placement with customized healing abutment
  arm group label: immediate implant placement with customized healing abutment
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Nesma Mohamed Fouad Shemais
  investigator title: Lecturer in the department of Oral Medicine & Periodontology
  mesh term: Shock