<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/NCT02996370</url>
  </required_header>
  <id_info>
    <org_study_id>EGE-OP 2013</org_study_id>
    <nct_id>NCT02996370</nct_id>
  </id_info>
  <brief_title>Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial</brief_title>
  <official_title>Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Regenerating a predictable inter-implant papilla is the most complex and challenging aspect&#xD;
      of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision&#xD;
      technique and conventional midcrestal incision technique for interimplant papilla&#xD;
      reconstruction in a 6 month clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 40 implants were placed in 12 patients. Groups were determined at second stage&#xD;
      surgery, I shape technique used in test group and mid-crestal technique used in control&#xD;
      group. The clinical parameters, including modified plaque index, modified sulcus bleeding&#xD;
      index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The&#xD;
      vertical distance between the crests top-contact point was evaluated with digital periapical&#xD;
      radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3&#xD;
      and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in&#xD;
      the taking of standardized images. With these images the ratio of the papilla area in&#xD;
      proportion to the embrasure area and the papilla classification was measured. Non-parametric&#xD;
      test were used for statistically analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>papilla fill index</measure>
    <time_frame>baseline</time_frame>
    <description>Baseline will be 1 week after cementation of the crowns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>papilla fill index</measure>
    <time_frame>3 month</time_frame>
    <description>Papilla fill index will be recorded 3rd month after baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>papilla fill index</measure>
    <time_frame>6 month</time_frame>
    <description>Papilla fill index will be recorded 6th month after baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>crestal bone loss</measure>
    <time_frame>Change from baseline crestal bone level up to 3 months</time_frame>
    <description>Crestal bone loss was measured on radiographs between baseline-3rd month.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>crestal bone loss</measure>
    <time_frame>Change from baseline crestal bone level up to 6 months</time_frame>
    <description>Crestal bone loss was measured on radiographs between baseline-6th month.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>vertical distance</measure>
    <time_frame>baseline, 3 and 6 month</time_frame>
    <description>Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>baseline</time_frame>
    <description>The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>3 month</time_frame>
    <description>The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>6 month</time_frame>
    <description>The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified sulcus bleeding index</measure>
    <time_frame>Modified sulcus bleeding index was recorded at baseline</time_frame>
    <description>Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified sulcus bleeding index</measure>
    <time_frame>Modified sulcus bleeding index was recorded at 3 month</time_frame>
    <description>Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified sulcus bleeding index</measure>
    <time_frame>Modified sulcus bleeding index was recorded at 6 month</time_frame>
    <description>Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified plaque index</measure>
    <time_frame>Modified plaque index was recorded at baseline</time_frame>
    <description>The dichotomous presence of supra gingival plaque was recorded at four sites of implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified plaque index</measure>
    <time_frame>Modified plaque index was recorded at 3 month</time_frame>
    <description>The dichotomous presence of supra gingival plaque was recorded at four sites of implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified plaque index</measure>
    <time_frame>Modified plaque index was recorded at 6 month</time_frame>
    <description>The dichotomous presence of supra gingival plaque was recorded at four sites of implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratinized tissue level</measure>
    <time_frame>Keratinized tissue level was recorded at baseline</time_frame>
    <description>Keratinized tissue level measured with a plastic periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratinized tissue level</measure>
    <time_frame>Keratinized tissue level was recorded at 3 month</time_frame>
    <description>Keratinized tissue level measured with a plastic periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratinized tissue level</measure>
    <time_frame>Keratinized tissue level was recorded at 6 month</time_frame>
    <description>Keratinized tissue level measured with a plastic periodontal probe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Tooth Loss</condition>
  <condition>Bone Loss</condition>
  <arm_group>
    <arm_group_label>Test group- ı shape incision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Second stage surgery was made I shape incision technique .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group- midcrestal incision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group second stage surgery was made using the conventional method, midcrestal technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>papilla fill index</intervention_name>
    <description>The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.</description>
    <arm_group_label>Control group- midcrestal incision</arm_group_label>
    <arm_group_label>Test group- ı shape incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>crestal bone loss</intervention_name>
    <description>Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)</description>
    <arm_group_label>Control group- midcrestal incision</arm_group_label>
    <arm_group_label>Test group- ı shape incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>probing depth</intervention_name>
    <description>The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)</description>
    <arm_group_label>Control group- midcrestal incision</arm_group_label>
    <arm_group_label>Test group- ı shape incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified sulcus bleeding index</intervention_name>
    <description>Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.</description>
    <arm_group_label>Control group- midcrestal incision</arm_group_label>
    <arm_group_label>Test group- ı shape incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified plaque index</intervention_name>
    <description>Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.</description>
    <arm_group_label>Control group- midcrestal incision</arm_group_label>
    <arm_group_label>Test group- ı shape incision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No sistemic condition, and age &gt; 18 years,&#xD;
&#xD;
          -  healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,&#xD;
&#xD;
          -  in a need of at least two collateral implants in the maxilla from second premolar to&#xD;
             second premolar&#xD;
&#xD;
          -  sufficient keratinized tissue&#xD;
&#xD;
          -  no bone augmentation procedures before implant placement&#xD;
&#xD;
          -  use of tobacco 10N ≥ cigarettes daily&#xD;
&#xD;
          -  sufficient distance between opposite occluding dentition at the proposed implant sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of aggressive periodontitis,&#xD;
&#xD;
          -  systemic diseases such as diabetes&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  radiation therapy in the head and neck area wihtin the previous 12 months,&#xD;
&#xD;
          -  heavy smokers&#xD;
&#xD;
          -  bruxism.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Özge PEHLİVANOĞLU</investigator_full_name>
    <investigator_title>Özge PEHLİVANOĞLU, PhD,DDS Ege University, School of Dentistry</investigator_title>
  </responsible_party>
  <keyword>esthetic</keyword>
  <keyword>inter-implant papilla</keyword>
  <keyword>soft tissue tickness</keyword>
  <keyword>crestal bone loss</keyword>
  <keyword>second stage surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</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/NCT02996370
org study id: EGE-OP 2013
nct id: NCT02996370
lead sponsor: 
has dmc: No
Regenerating a predictable inter-implant papilla is the most complex and challenging aspect
      of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision
      technique and conventional midcrestal incision technique for interimplant papilla
      reconstruction in a 6 month clinical trial.
A total of 40 implants were placed in 12 patients. Groups were determined at second stage
      surgery, I shape technique used in test group and mid-crestal technique used in control
      group. The clinical parameters, including modified plaque index, modified sulcus bleeding
      index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The
      vertical distance between the crests top-contact point was evaluated with digital periapical
      radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3
      and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in
      the taking of standardized images. With these images the ratio of the papilla area in
      proportion to the embrasure area and the papilla classification was measured. Non-parametric
      test were used for statistically analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: papilla fill index
time frame: baseline
description: Baseline will be 1 week after cementation of the crowns.
measure: papilla fill index
time frame: 3 month
description: Papilla fill index will be recorded 3rd month after baseline
measure: papilla fill index
time frame: 6 month
description: Papilla fill index will be recorded 6th month after baseline
measure: crestal bone loss
time frame: Change from baseline crestal bone level up to 3 months
description: Crestal bone loss was measured on radiographs between baseline-3rd month.
measure: crestal bone loss
time frame: Change from baseline crestal bone level up to 6 months
description: Crestal bone loss was measured on radiographs between baseline-6th month.
measure: vertical distance
time frame: baseline, 3 and 6 month
description: Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
measure: Probing depth
time frame: baseline
description: The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
measure: Probing depth
time frame: 3 month
description: The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.
measure: Probing depth
time frame: 6 month
description: The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.
measure: Modified sulcus bleeding index
time frame: Modified sulcus bleeding index was recorded at baseline
description: Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
measure: Modified sulcus bleeding index
time frame: Modified sulcus bleeding index was recorded at 3 month
description: Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
measure: Modified sulcus bleeding index
time frame: Modified sulcus bleeding index was recorded at 6 month
description: Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
measure: Modified plaque index
time frame: Modified plaque index was recorded at baseline
description: The dichotomous presence of supra gingival plaque was recorded at four sites of implants
measure: Modified plaque index
time frame: Modified plaque index was recorded at 3 month
description: The dichotomous presence of supra gingival plaque was recorded at four sites of implants
measure: Modified plaque index
time frame: Modified plaque index was recorded at 6 month
description: The dichotomous presence of supra gingival plaque was recorded at four sites of implants
measure: Keratinized tissue level
time frame: Keratinized tissue level was recorded at baseline
description: Keratinized tissue level measured with a plastic periodontal probe
measure: Keratinized tissue level
time frame: Keratinized tissue level was recorded at 3 month
description: Keratinized tissue level measured with a plastic periodontal probe
measure: Keratinized tissue level
time frame: Keratinized tissue level was recorded at 6 month
description: Keratinized tissue level measured with a plastic periodontal probe
arm group label: Test group- ı shape incision
arm group type: Active Comparator
description: Second stage surgery was made I shape incision technique .
arm group label: Control group- midcrestal incision
arm group type: Active Comparator
description: In the control group second stage surgery was made using the conventional method, midcrestal technique.
intervention type: Other
intervention name: papilla fill index
description: The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.
arm group label: Control group- midcrestal incision
arm group label: Test group- ı shape incision
intervention type: Other
intervention name: crestal bone loss
description: Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
arm group label: Control group- midcrestal incision
arm group label: Test group- ı shape incision
intervention type: Other
intervention name: probing depth
description: The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)
arm group label: Control group- midcrestal incision
arm group label: Test group- ı shape incision
intervention type: Other
intervention name: Modified sulcus bleeding index
description: Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
arm group label: Control group- midcrestal incision
arm group label: Test group- ı shape incision
intervention type: Other
intervention name: Modified plaque index
description: Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.
arm group label: Control group- midcrestal incision
arm group label: Test group- ı shape incision
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Özge PEHLİVANOĞLU
investigator title: Özge PEHLİVANOĞLU, PhD,DDS Ege University, School of Dentistry
mesh term: Tooth Loss
sharing ipd: Undecided