<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/NCT03007316</url>
  </required_header>
  <id_info>
    <org_study_id>0</org_study_id>
    <nct_id>NCT03007316</nct_id>
  </id_info>
  <brief_title>Evaluation of Esthetics Around Immediate Implants in VIP - CT Grafted vs Non-grafted Sites.RCT</brief_title>
  <official_title>Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implants in Vascularized Interpositional Periosteal Connective Tissue Grafted Versus Non-grafted Sites. A Randomized Controlled 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>
      An array of soft tissue augmentation techniques have been employed concomitant to implant&#xD;
      placement, as free connective tissue grafts or pedicle grafts for keratinized tissue&#xD;
      thickening in attempt not only to augment the soft tissue for better resistance to&#xD;
      inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.&#xD;
&#xD;
      Results obtained from the literature were controversial regarding the need of soft tissue&#xD;
      augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature&#xD;
      was found, that monitored the ridge alterations following implant placement.&#xD;
&#xD;
      Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and&#xD;
      buccal bone resorption during the process of remodeling in a measurable way.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alveolar bone remodeling following extraction could not be prevented by immediate implant&#xD;
      placement. Soft tissue augmentaion techniques have been suggested in order to overcome the&#xD;
      alterations of buccal bone during remodeling. Nevertheless, it is still inconclusive whether&#xD;
      soft tissue augmentation procedures actually have a protective role in preserving buccal bone&#xD;
      thickness in immediate implants.&#xD;
&#xD;
      Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal&#xD;
      bone resorption and pink esthetics around immediately placed implants in maxillary anterior&#xD;
      teeth after 24 months following implant placement. 18 non-restorable maxillary anterior teeth&#xD;
      randomly assigned into 2 groups: (test group) immediately placed implants with simultaneous&#xD;
      vascular interpositional periosteal connective tissue (VIP-CT) grafting versus non-augmented&#xD;
      implant sites (control group). Buccal bone changes were assessed at implant placement (0) and&#xD;
      at 4,9,12 and 24 months from baseline by specially manufactured device and at 24 months by&#xD;
      cone beam computed tomography scans (CBCT). Pink esthetic score (PES) was evaluated at 6, 9,&#xD;
      12 and 24 months intervals. Pain and satisfaction were assessed through questionnaires to the&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">March 12, 2020</completion_date>
  <primary_completion_date type="Actual">December 17, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>&quot;PES&quot; Pink Esthetic Score</measure>
    <time_frame>2 years</time_frame>
    <description>esthetic assessment by the pink esthetic score introduced by furhauser et al 2005</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Buccal Bone Loss in Immediate Implants</condition>
  <arm_group>
    <arm_group_label>Immediate Implants + VIP graft.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediate implants placed with simultaneous vascularized interpositional periosteal (VIP) connective tissue graft augmentation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Implants only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Immediate Implants only without soft tissue augmentation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VIP graft</intervention_name>
    <description>surgical soft tissue grafting concomitant to implant placement</description>
    <arm_group_label>Immediate Implants + VIP graft.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have at least one unrestorable tooth in the esthetic zone that needs to&#xD;
             be extracted.&#xD;
&#xD;
          -  Patients with healthy systemic condition.&#xD;
&#xD;
          -  Buccal bone thickness should be at least 1mm.&#xD;
&#xD;
          -  Availability of bone apical and palatal to the socket to provide primary stability.&#xD;
&#xD;
          -  Good oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with signs of acute infection related to the area of interest.&#xD;
&#xD;
          -  Current and former smokers&#xD;
&#xD;
          -  Pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hani El Nahass, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Greater Cairo</state>
        <zip>12613</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Suzy Nabil Naiem</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03007316
org study id: 0
nct id: NCT03007316
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
An array of soft tissue augmentation techniques have been employed concomitant to implant
      placement, as free connective tissue grafts or pedicle grafts for keratinized tissue
      thickening in attempt not only to augment the soft tissue for better resistance to
      inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.

      Results obtained from the literature were controversial regarding the need of soft tissue
      augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature
      was found, that monitored the ridge alterations following implant placement.

      Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and
      buccal bone resorption during the process of remodeling in a measurable way.
Alveolar bone remodeling following extraction could not be prevented by immediate implant
      placement. Soft tissue augmentaion techniques have been suggested in order to overcome the
      alterations of buccal bone during remodeling. Nevertheless, it is still inconclusive whether
      soft tissue augmentation procedures actually have a protective role in preserving buccal bone
      thickness in immediate implants.

      Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal
      bone resorption and pink esthetics around immediately placed implants in maxillary anterior
      teeth after 24 months following implant placement. 18 non-restorable maxillary anterior teeth
      randomly assigned into 2 groups: (test group) immediately placed implants with simultaneous
      vascular interpositional periosteal connective tissue (VIP-CT) grafting versus non-augmented
      implant sites (control group). Buccal bone changes were assessed at implant placement (0) and
      at 4,9,12 and 24 months from baseline by specially manufactured device and at 24 months by
      cone beam computed tomography scans (CBCT). Pink esthetic score (PES) was evaluated at 6, 9,
      12 and 24 months intervals. Pain and satisfaction were assessed through questionnaires to the
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: "PES" Pink Esthetic Score
time frame: 2 years
description: esthetic assessment by the pink esthetic score introduced by furhauser et al 2005
arm group label: Immediate Implants + VIP graft.
arm group type: Experimental
description: Immediate implants placed with simultaneous vascularized interpositional periosteal (VIP) connective tissue graft augmentation.
arm group label: Immediate Implants only
arm group type: No Intervention
description: Immediate Implants only without soft tissue augmentation.
intervention type: Procedure
intervention name: VIP graft
description: surgical soft tissue grafting concomitant to implant placement
arm group label: Immediate Implants + VIP graft.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hani El Nahass, PhD
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Suzy Nabil Naiem
investigator title: Principal Investigator