<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/NCT03768297</url>
  </required_header>
  <id_info>
    <org_study_id>2508</org_study_id>
    <nct_id>NCT03768297</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implant Using Dual Zone Therapeutic Concept Versus Buccal Gap Fill to Bone Level</brief_title>
  <official_title>Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implant Using Dual Zone Therapeutic Concept Versus Buccal Gap Fill to Bone Level.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>
      Immediate implant placement in the esthetic zone is very challenging procedure although it is&#xD;
      documented as a promising procedure (Berglundh, Persson and Klinge, 2002)(Cosyn et al.,&#xD;
      2011). Extraction is usually accompanied by remodeling of the hard tissues which is more&#xD;
      crucial in the anterior maxilla as it affects soft tissue esthetics(Araujo and Lindhe,&#xD;
      2005)(Covani et al., 2004)(Juodzbalys and Wang, 2007). It is well established that implant&#xD;
      placement without filling the buccal gap leads to noticeable amount of bone loss at the&#xD;
      alveolar contour(Botticelli, Berglundh and Lindhe, 2004)(Sanz et al., 2010). The protocol of&#xD;
      immediate implant and temporization serves to provide acceptable esthetic results but soft&#xD;
      tissue stability around the implant restoration is not always satisfactory(Noelken et al.,&#xD;
      2018).Amount of soft tissue recession can be specified following immediate implant placement,&#xD;
      even with flapless technique there is a limited risk of midfacial recession(Cosyn, Hooghe and&#xD;
      De Bruyn, 2012).It was found that inadequate bone grafting in the facial defect increases the&#xD;
      chance of mid facial recession(Le, Borzabadi-Farahani and Pluemsakunthai, 2014).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By definition, the dual zone can be divided into soft tissue zone and bone zone; the soft&#xD;
      tissue zone is the vertical dimension change measured from the free gingival margin to the&#xD;
      mid crest labially, the bone zone is the hard tissues measured from the crestal bone towards&#xD;
      the apex(Chu et al., 2012). The concept of the dual zone aims to maintain the hard, soft&#xD;
      tissue volume and the blood clot where the grafting material act as a scaffold containing&#xD;
      them and this will enhance the initial healing compared to the classic protocol of bone&#xD;
      filling till the buccal bone level(Chu et al., 2012). A recent study claims that the&#xD;
      xenograft particles can be successfully incorporated within the soft tissue without&#xD;
      inflammation enhancing the soft tissue profile(Araujo and Lindhe, 2005). The temporary&#xD;
      restoration has shown socket sealing property which protect and contain the blood clot and&#xD;
      the graft material enhancing healing,thus filling the gap without involvement of the soft&#xD;
      tissue has been the rational for immediate implant placement(Trimpou G, Weigl P, Krebs M,&#xD;
      2010).The main benefit of the dual zone concept is maintaining the blood supply from the&#xD;
      periosteum and endosteum producing maximum healing potential with preserving the soft tissue&#xD;
      stability by filling the soft tissue zone with bone graft in addition to immediate&#xD;
      temporization acting as socket seal(Chu et al., 2012).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 20, 2018</start_date>
  <completion_date type="Anticipated">November 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 20, 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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pink Esthetic Score</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, softtissuecontour, alveolar process deficiency,soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score,with 2 being the best and 0 being thepoorest score.The mesial and distal papilla will be evaluatedfor completeness, incompleteness orabsence. All other variables will be assessedby comparison to a reference tooth.(Fürhauser et al., 2005)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Buccal bone thickness</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>using a specially designed device that will be screwed to the fixture. (Merheb et al., 2016)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Thickness</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>Will be measured using an anesthetic needle with a rubber stopper,transgingivally piercing tissues horizontally,perpendicular to the long axis of the tooth/implant until it contacts bone, at 9 different points; three readings: mesially, midbuccally and distally at three different levels; 2mm, 4mm and 6mm apical to the gingival margin.The lengthof the part of the instrument that penetratedinto the soft tissue is measured in mm.(Wiesner et al., 2010)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratinized tissue width</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative swelling</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area), assessed during the first 7 postoperative days. (García et al., 2008)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Surgical Patient Satisfaction: Questionnaire</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>A 3-item questionnaire is asked and the patients shall use a 7 point answer scale. (Kiyak et al., 1984)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Immediate Implant and Bone Graft</condition>
  <arm_group>
    <arm_group_label>immediate implant with dual zone therapeutic concept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>immediate implant with buccal bone fill</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>dual zone concept</intervention_name>
    <description>immediate implant with bone fill till soft tissue level</description>
    <arm_group_label>immediate implant with buccal bone fill</arm_group_label>
    <arm_group_label>immediate implant with dual zone therapeutic concept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have at least one non restorable tooth in the esthetic zone that needs to&#xD;
             be extracted.&#xD;
&#xD;
          2. Patients with healthy systemic condition.(Brightman. 1994)&#xD;
&#xD;
          3. Patients aged from 20 to 45 years old.&#xD;
&#xD;
          4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014)&#xD;
&#xD;
          5. Availability of bone apical and palatal to the socket to provide primary&#xD;
             stability.(Morton et al., 2014)&#xD;
&#xD;
          6. Good oral hygiene.(Wiesner et al., 2010)&#xD;
&#xD;
          7. Accepts one year follow-up period (cooperative patients).&#xD;
&#xD;
          8. Patient provides an informed consent.&#xD;
&#xD;
          9. Adequate Inter-arch space for implant placement.&#xD;
&#xD;
         10. favorable occlusion (no traumatic occlusion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with signs of acute infection related to the area of interest.&#xD;
&#xD;
          2. Patients with habits that may jeopardize the implant longevity and affect the results&#xD;
             of the study such as parafunctional habits (Lobbezoo et al., 2006).&#xD;
&#xD;
          3. Current and former smokers (Lambert, Morris and Ochi, 2000)&#xD;
&#xD;
          4. Pregnant females.&#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>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>RWGWanis</investigator_full_name>
    <investigator_title>Clinical Evaluation of soft tissue esthetics around immediate implant using dual zone therapeutic concept versus buccal gap fill to bone level</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/NCT03768297
org study id: 2508
nct id: NCT03768297
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Immediate implant placement in the esthetic zone is very challenging procedure although it is
      documented as a promising procedure (Berglundh, Persson and Klinge, 2002)(Cosyn et al.,
      2011). Extraction is usually accompanied by remodeling of the hard tissues which is more
      crucial in the anterior maxilla as it affects soft tissue esthetics(Araujo and Lindhe,
      2005)(Covani et al., 2004)(Juodzbalys and Wang, 2007). It is well established that implant
      placement without filling the buccal gap leads to noticeable amount of bone loss at the
      alveolar contour(Botticelli, Berglundh and Lindhe, 2004)(Sanz et al., 2010). The protocol of
      immediate implant and temporization serves to provide acceptable esthetic results but soft
      tissue stability around the implant restoration is not always satisfactory(Noelken et al.,
      2018).Amount of soft tissue recession can be specified following immediate implant placement,
      even with flapless technique there is a limited risk of midfacial recession(Cosyn, Hooghe and
      De Bruyn, 2012).It was found that inadequate bone grafting in the facial defect increases the
      chance of mid facial recession(Le, Borzabadi-Farahani and Pluemsakunthai, 2014).
By definition, the dual zone can be divided into soft tissue zone and bone zone; the soft
      tissue zone is the vertical dimension change measured from the free gingival margin to the
      mid crest labially, the bone zone is the hard tissues measured from the crestal bone towards
      the apex(Chu et al., 2012). The concept of the dual zone aims to maintain the hard, soft
      tissue volume and the blood clot where the grafting material act as a scaffold containing
      them and this will enhance the initial healing compared to the classic protocol of bone
      filling till the buccal bone level(Chu et al., 2012). A recent study claims that the
      xenograft particles can be successfully incorporated within the soft tissue without
      inflammation enhancing the soft tissue profile(Araujo and Lindhe, 2005). The temporary
      restoration has shown socket sealing property which protect and contain the blood clot and
      the graft material enhancing healing,thus filling the gap without involvement of the soft
      tissue has been the rational for immediate implant placement(Trimpou G, Weigl P, Krebs M,
      2010).The main benefit of the dual zone concept is maintaining the blood supply from the
      periosteum and endosteum producing maximum healing potential with preserving the soft tissue
      stability by filling the soft tissue zone with bone graft in addition to immediate
      temporization acting as socket seal(Chu et al., 2012).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double blinded
measure: Pink Esthetic Score
time frame: 12 months post surgery
description: The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, softtissuecontour, alveolar process deficiency,soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score,with 2 being the best and 0 being thepoorest score.The mesial and distal papilla will be evaluatedfor completeness, incompleteness orabsence. All other variables will be assessedby comparison to a reference tooth.(Fürhauser et al., 2005)
measure: Buccal bone thickness
time frame: 12 months post surgery
description: using a specially designed device that will be screwed to the fixture. (Merheb et al., 2016)
measure: Gingival Thickness
time frame: 12 months post surgery
description: Will be measured using an anesthetic needle with a rubber stopper,transgingivally piercing tissues horizontally,perpendicular to the long axis of the tooth/implant until it contacts bone, at 9 different points; three readings: mesially, midbuccally and distally at three different levels; 2mm, 4mm and 6mm apical to the gingival margin.The lengthof the part of the instrument that penetratedinto the soft tissue is measured in mm.(Wiesner et al., 2010)
measure: Keratinized tissue width
time frame: 12 months post surgery
description: Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.
measure: Post operative swelling
time frame: 12 months post surgery
description: Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area), assessed during the first 7 postoperative days. (García et al., 2008)
measure: Post Surgical Patient Satisfaction: Questionnaire
time frame: 12 months post surgery
description: A 3-item questionnaire is asked and the patients shall use a 7 point answer scale. (Kiyak et al., 1984)
arm group label: immediate implant with dual zone therapeutic concept
arm group type: Experimental
arm group label: immediate implant with buccal bone fill
arm group type: Active Comparator
intervention type: Procedure
intervention name: dual zone concept
description: immediate implant with bone fill till soft tissue level
arm group label: immediate implant with buccal bone fill
arm group label: immediate implant with dual zone therapeutic concept
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: RWGWanis
investigator title: Clinical Evaluation of soft tissue esthetics around immediate implant using dual zone therapeutic concept versus buccal gap fill to bone level