<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/NCT03770975</url>
  </required_header>
  <id_info>
    <org_study_id>Dinaosamaperio</org_study_id>
    <nct_id>NCT03770975</nct_id>
  </id_info>
  <brief_title>Comparison of Peri Implant Soft Tissue Esthetics With Immediate Temporization With and Without Subepithelial Connective Tissue Graft</brief_title>
  <official_title>Comparison of Peri-implant Soft Tissue Esthetics Around Single Delayed Implant With Immediate Provisionalization Placed in The Esthetic Zone With and Without Using Subepithelial Connective Tissue Graft: A 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>
    <has_dmc>No</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>
      The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around&#xD;
      single delayed implants in the esthetic zone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics&#xD;
      along with immediate temporization to immediate temporization only.&#xD;
&#xD;
      Population (P): patients with a single missing tooth in the esthetic zone Intervention (I):&#xD;
      Delayed implant placement with immediate temporization and subepithelial connective tissue&#xD;
      graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome:&#xD;
      Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical&#xD;
      trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>Phase 3</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>Pink Esthetic Score</measure>
    <time_frame>3 months post definitive prosthesis</time_frame>
    <description>Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction by Visual analogue scale (VAS)</measure>
    <time_frame>3 months post definitive</time_frame>
    <description>Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled &quot;much less than natural teeth&quot; which is marked by zero and the left anchor labeled &quot;much more&quot; which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Buccal peri-implant soft tissue thickness</measure>
    <time_frame>3 months post definitive</time_frame>
    <description>the soft tissue thickness buccal to the implant by using an anesthesia needle and digital caliper</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recession of the buccal peri-implant mucosa</measure>
    <time_frame>3 months post definitive</time_frame>
    <description>measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants</condition>
  <arm_group>
    <arm_group_label>Delayed implant placement with immediate provisionalization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Implant with immediate temporization and soft tissue graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>delayed implant with immediate provisionaliztion and soft tissue graft</intervention_name>
    <description>delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal</description>
    <arm_group_label>Delayed implant placement with immediate provisionalization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>delayed implant placement with immediate provisionalization</intervention_name>
    <description>delayed implant placement with immediate provisionalization</description>
    <arm_group_label>Implant with immediate temporization and soft tissue graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years old&#xD;
&#xD;
          2. Good medical and psychological health&#xD;
&#xD;
          3. Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If&#xD;
             patients required periodontal treatment (non-surgical and/or surgical), this was&#xD;
             arranged outside the study protocol and completed at least 30 days prior to the&#xD;
             enrolment&#xD;
&#xD;
          4. Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar)&#xD;
             region&#xD;
&#xD;
          5. Willingness to sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any known disease (not including controlled diabetes mellitus), infections or recent&#xD;
             surgical procedures within 30 days of study initiation;&#xD;
&#xD;
          2. Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral&#xD;
             status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within&#xD;
             1 month before baseline visit;&#xD;
&#xD;
          3. Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin&#xD;
             (more than 81 mg);&#xD;
&#xD;
          4. HIV or Hepatitis;&#xD;
&#xD;
          5. Physical handicaps that would interfere with the ability to perform adequate oral&#xD;
             hygiene;&#xD;
&#xD;
          6. Alcoholism or chronic drug abuse;&#xD;
&#xD;
          7. Heavy smokers (&gt;10/cigarettes per day);&#xD;
&#xD;
          8. Lack of adequate primary stability at implant insertion that enables immediate&#xD;
             provisionalization (insertion torque ca 30 Ncm).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Azza Ezz AlArab, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor in the department of Oral Medicine and Periodontology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dina Osama, Bachelor</last_name>
    <phone>01003808409</phone>
    <phone_ext>002</phone_ext>
    <email>dina.osama@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hany ElNahass, PHD</last_name>
    <phone>01000252603</phone>
    <phone_ext>002</phone_ext>
    <email>Nahass77@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Hany ElNahass, PHD</last_name>
      <email>Nahass77@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dina Osama Abdelwahab Megahed</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03770975
org study id: Dinaosamaperio
nct id: NCT03770975
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around
      single delayed implants in the esthetic zone.
To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics
      along with immediate temporization to immediate temporization only.

      Population (P): patients with a single missing tooth in the esthetic zone Intervention (I):
      Delayed implant placement with immediate temporization and subepithelial connective tissue
      graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome:
      Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical
      trial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pink Esthetic Score
time frame: 3 months post definitive prosthesis
description: Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
measure: Patient satisfaction by Visual analogue scale (VAS)
time frame: 3 months post definitive
description: Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled "much less than natural teeth" which is marked by zero and the left anchor labeled "much more" which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line.
measure: Buccal peri-implant soft tissue thickness
time frame: 3 months post definitive
description: the soft tissue thickness buccal to the implant by using an anesthesia needle and digital caliper
measure: Recession of the buccal peri-implant mucosa
time frame: 3 months post definitive
description: measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins.
arm group label: Delayed implant placement with immediate provisionalization
arm group type: Active Comparator
description: Single delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery
arm group label: Implant with immediate temporization and soft tissue graft
arm group type: Experimental
description: Single delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery
intervention type: Procedure
intervention name: delayed implant with immediate provisionaliztion and soft tissue graft
description: delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal
arm group label: Delayed implant placement with immediate provisionalization
intervention type: Procedure
intervention name: delayed implant placement with immediate provisionalization
description: delayed implant placement with immediate provisionalization
arm group label: Implant with immediate temporization and soft tissue graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Azza Ezz AlArab, PHD
role: Study Chair
affiliation: Professor in the department of Oral Medicine and Periodontology
last name: Dina Osama, Bachelor
phone: 01003808409
phone ext: 002
email: dina.osama@dentistry.cu.edu.eg
last name: Hany ElNahass, PHD
phone: 01000252603
phone ext: 002
email: Nahass77@gmail.com
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dina Osama Abdelwahab Megahed
investigator title: Resident
sharing ipd: No