<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/NCT02210143</url>
  </required_header>
  <id_info>
    <org_study_id>CUDHF-2011-8-6</org_study_id>
    <nct_id>NCT02210143</nct_id>
  </id_info>
  <brief_title>An Explorative Study To Develop A Predictive Model Based On Avascular Exposed Root Surface Area For Root Coverage</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova University</source>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the reliability of the avascular root surface area as a&#xD;
      prognostic identification criterion for gingival recessions and to compare the predictive&#xD;
      value of the Miller classification and avascular root surface area (AERSA) calculation on the&#xD;
      final root coverage outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complete root coverage</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean root coverage</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">91</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>AERSA-I gingival recession</arm_group_label>
    <description>The AERSA classification was developed based on 15 mm2 which is the lowest cut-off point and the group of AERSA ≤ 15 mm2 named as AERSA-I (low risk group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AERSA-II gingival recession</arm_group_label>
    <description>AERSA &gt; 15 mm2 named as AERSA-II (high risk group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miller gingival recession</arm_group_label>
    <description>Gingival recessions classified according to Miller</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Ninety one patients, 41 females and 50 males, aged between 21-41 years, with 91 isolated&#xD;
        single gingival recessions (32 Miller I, 29 Miller II, 30 Miller III defects) located at&#xD;
        upper and lower incisors and canines.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of isolated Miller I, II or III recession, (Miller 1985a)&#xD;
&#xD;
          -  Presence of identifiable cementoenamel junction (CEJ); presence of a step ≤ 2mm at CEJ&#xD;
             level and/or the presence of a root abrasion, but with an identifiable CEJ,&#xD;
&#xD;
          -  Full-mouth plaque score and Full-mouth bleeding score of &lt; 15% (four sites/tooth),&#xD;
&#xD;
          -  No occlusal interferences;&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tooth with a prosthetic restoration involving CEJ,&#xD;
&#xD;
          -  Patients with a history of periodontitis or abscess formation,&#xD;
&#xD;
          -  Presence of systemic disease or taking medications known to interfere with periodontal&#xD;
             tissue health&#xD;
&#xD;
          -  Pregnant or nursing patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>41 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cukurova University Ethics Comitee</name>
      <address>
        <city>Adana</city>
        <state>Balcali</state>
        <zip>01130</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Onur Ozcelik</investigator_full_name>
    <investigator_title>Prof.</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>
  <!-- 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/NCT02210143
org study id: CUDHF-2011-8-6
nct id: NCT02210143
lead sponsor: 
The aim of this study was to evaluate the reliability of the avascular root surface area as a
      prognostic identification criterion for gingival recessions and to compare the predictive
      value of the Miller classification and avascular root surface area (AERSA) calculation on the
      final root coverage outcomes.
time perspective: Prospective
measure: Complete root coverage
time frame: 6 months
measure: mean root coverage
time frame: 6 months
arm group label: AERSA-I gingival recession
description: The AERSA classification was developed based on 15 mm2 which is the lowest cut-off point and the group of AERSA ≤ 15 mm2 named as AERSA-I (low risk group)
arm group label: AERSA-II gingival recession
description: AERSA > 15 mm2 named as AERSA-II (high risk group).
arm group label: Miller gingival recession
description: Gingival recessions classified according to Miller
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 41 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Onur Ozcelik
investigator title: Prof.
mesh term: Gingival Recession