<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/NCT03802370</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2019-01-10</org_study_id>
    <nct_id>NCT03802370</nct_id>
  </id_info>
  <brief_title>Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone</brief_title>
  <official_title>Soft Tissue Augmentation Using The Dome Technique Around Immediate Implants In The Esthetic Zone. A Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Following tooth loss, a considerable reduction in hard- and soft-tissue volume can be&#xD;
      expected (Tan WL, et al., 2012), (AraujoMG, et al., 2015). In the anterior maxilla, tissue&#xD;
      loss can make future implant restorations more challenging and less predictable in terms of&#xD;
      achieving and maintaining favorable soft-tissue-emergence profiles. Even with careful implant&#xD;
      planning and placement, marginal gingival recession of 0.5-1 mm has been a common finding&#xD;
      with single-tooth implants (Nisapakultorn K, et al., 2010), (Suphanantachat S, et al., 2012).&#xD;
      This is partly attributed to bone remodeling after implant surgery, and occurs regardless of&#xD;
      implant-placement protocol used (Hof M, et al., 2015).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dome technique addresses the placement of the CT, as it is layered over the implant and&#xD;
      takes the shape of an inverted dome. The advantage of the dome CT technique is that it allows&#xD;
      for both buccal and coronal augmentation of local soft tissue, while maximizing blood supply&#xD;
      to the area by using tunneling-technique principles. It enhances and augments the&#xD;
      peri-implant tissue foundation for a favorable facial and interproximal restorative emergence&#xD;
      profile. As this technique does not involve raising an independent buccal flap, the gingival&#xD;
      tissue of the adjacent teeth is not compromised, and thus the risk of recession and formation&#xD;
      of black triangles on the adjacent teeth is minimized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</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>
    <intervention_model_description>single arm groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pink esthetic score (PES)</measure>
    <time_frame>6 months</time_frame>
    <description>The PES is based on seven variables mesial papilla, distal papilla, soft - tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture . The PES is based on seven variables mesial papilla, distal papilla, soft - tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture . it's numerical</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival Thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth implant until it contacts bone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post - Surgical Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>A 3 - item questionnaire is asked and the patients shall use a 7point answer scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Recession, Gingival</condition>
  <arm_group>
    <arm_group_label>single am</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>single arm , superiority trial , tunneling technique in connective tissue graft around dental implants</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>connective tissue grafting by Dome Technique</intervention_name>
    <description>The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome</description>
    <arm_group_label>single am</arm_group_label>
    <other_name>Dome technique</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with healthy systemic condition&#xD;
&#xD;
          -  Patients aged from 20 to 45 years old Availability of bone apical and palatal to the&#xD;
             socket to provide primary stability.&#xD;
&#xD;
          -  Presence of adequate gingival architecture with the surrounding dentition&#xD;
&#xD;
          -  Patient provides an informed consent&#xD;
&#xD;
          -  Adequate Inter-arch space for implant placement&#xD;
&#xD;
          -  Favorable occlusion (no traumatic occlusion)&#xD;
&#xD;
          -  Good oral hygiene&#xD;
&#xD;
          -  Accepts 6-month follow-up period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with signs of acute infection related to the area of interest&#xD;
&#xD;
          -  Patients with habits that may jeopardize the implant longevity and affect the results&#xD;
             of the study such as para-functional habits&#xD;
&#xD;
          -  Current and former smokers&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  HIV or Hepatitis; 5/Physical handicaps that would interfere with the ability to&#xD;
             perform adequate oral hygiene&#xD;
&#xD;
          -  Alcoholism or chronic drug abuse; 7/ Heavy smokers &gt;10/cigarettes per day&#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>
  <reference>
    <citation>Irinakis T, Aldahlawi S. The dome technique: a new surgical technique to enhance soft-tissue margins and emergence profiles around implants placed in the esthetic zone. Clin Cosmet Investig Dent. 2018 Feb 14;10:1-7. doi: 10.2147/CCIDE.S154152. eCollection 2018.</citation>
    <PMID>29491722</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yasmine Abbas Elsayed</investigator_full_name>
    <investigator_title>professor: Mona Shoeib , associated professor: Enji ahmed mahmoud</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03802370
org study id: CEBD-CU-2019-01-10
nct id: NCT03802370
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Following tooth loss, a considerable reduction in hard- and soft-tissue volume can be
      expected (Tan WL, et al., 2012), (AraujoMG, et al., 2015). In the anterior maxilla, tissue
      loss can make future implant restorations more challenging and less predictable in terms of
      achieving and maintaining favorable soft-tissue-emergence profiles. Even with careful implant
      planning and placement, marginal gingival recession of 0.5-1 mm has been a common finding
      with single-tooth implants (Nisapakultorn K, et al., 2010), (Suphanantachat S, et al., 2012).
      This is partly attributed to bone remodeling after implant surgery, and occurs regardless of
      implant-placement protocol used (Hof M, et al., 2015).
The dome technique addresses the placement of the CT, as it is layered over the implant and
      takes the shape of an inverted dome. The advantage of the dome CT technique is that it allows
      for both buccal and coronal augmentation of local soft tissue, while maximizing blood supply
      to the area by using tunneling-technique principles. It enhances and augments the
      peri-implant tissue foundation for a favorable facial and interproximal restorative emergence
      profile. As this technique does not involve raising an independent buccal flap, the gingival
      tissue of the adjacent teeth is not compromised, and thus the risk of recession and formation
      of black triangles on the adjacent teeth is minimized.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single arm groups
primary purpose: Treatment
masking: None (Open Label)
measure: Pink esthetic score (PES)
time frame: 6 months
description: The PES is based on seven variables mesial papilla, distal papilla, soft - tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture . The PES is based on seven variables mesial papilla, distal papilla, soft - tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture . it's numerical
measure: Gingival Thickness
time frame: 6 months
description: Will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth implant until it contacts bone
measure: Post - Surgical Patient Satisfaction
time frame: 6 months
description: A 3 - item questionnaire is asked and the patients shall use a 7point answer scale
arm group label: single am
arm group type: Other
description: single arm , superiority trial , tunneling technique in connective tissue graft around dental implants
intervention type: Procedure
intervention name: connective tissue grafting by Dome Technique
description: The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome
arm group label: single am
other name: Dome technique
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Irinakis T, Aldahlawi S. The dome technique: a new surgical technique to enhance soft-tissue margins and emergence profiles around implants placed in the esthetic zone. Clin Cosmet Investig Dent. 2018 Feb 14;10:1-7. doi: 10.2147/CCIDE.S154152. eCollection 2018.
PMID: 29491722
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yasmine Abbas Elsayed
investigator title: professor: Mona Shoeib , associated professor: Enji ahmed mahmoud
mesh term: Gingival Recession
sharing ipd: Undecided