<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/NCT03273010</url>
  </required_header>
  <id_info>
    <org_study_id>Ordu Uni</org_study_id>
    <nct_id>NCT03273010</nct_id>
  </id_info>
  <brief_title>The Use of Cyanoacrylate on Palatal Wound</brief_title>
  <official_title>The Efficacy of Cyanoacrylate on Palatal Wound Healing and Postoperative Complaints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The palatal donor site of autogenous free gingival grafts significantly influences the&#xD;
      patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate&#xD;
      on palatal wound healing and postoperative complaints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 35 patients were included in the study. In the test group (19 patient),&#xD;
      cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients&#xD;
      were allowed to heal in a conventional way without cyanoacrylate.&#xD;
&#xD;
      Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of&#xD;
      epithelization were assessed following free gingival graft operation. As a result, compared&#xD;
      to the control group it was determined that the cyanoacrylate tissue adhesive could reduce&#xD;
      the postoperative morbidity and improve the wound healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary bleeding time</measure>
    <time_frame>baseline</time_frame>
    <description>The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>1-7 days after operation</time_frame>
    <description>The changes in postoperative pain level after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic consumption</measure>
    <time_frame>1-7 days after operation</time_frame>
    <description>The changes in the number of painkiller taken to relieve pain after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of epithelization</measure>
    <time_frame>Once a week for a month after the operation</time_frame>
    <description>The epithelization assessed by the peroxide test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>Periacryl group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Free gingival graft was harvested from palatal region and left to heal without applying periacryl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Free gingival graft</intervention_name>
    <description>Free gingival graft was harvested from palatal donor site</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Periacryl group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cyanoacrylate application</intervention_name>
    <description>Periacyrl was applied on palatal wounds</description>
    <arm_group_label>Periacryl group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no systemic diseases&#xD;
&#xD;
          -  no coagulation disorders&#xD;
&#xD;
          -  no drug intake in the previous 6 months that might effect the periodontal health&#xD;
             status&#xD;
&#xD;
          -  no pregnancy or lactation&#xD;
&#xD;
          -  no smoking habit&#xD;
&#xD;
          -  &lt;1 mm attached gingiva width on one or two lower anterior teeth&#xD;
&#xD;
          -  Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematologic disorders&#xD;
&#xD;
          -  No cooperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Ceren Gökmenoğlu</investigator_full_name>
    <investigator_title>Assistant Professor</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/NCT03273010
org study id: Ordu Uni
nct id: NCT03273010
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The palatal donor site of autogenous free gingival grafts significantly influences the
      patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate
      on palatal wound healing and postoperative complaints.
A total of 35 patients were included in the study. In the test group (19 patient),
      cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients
      were allowed to heal in a conventional way without cyanoacrylate.

      Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of
      epithelization were assessed following free gingival graft operation. As a result, compared
      to the control group it was determined that the cyanoacrylate tissue adhesive could reduce
      the postoperative morbidity and improve the wound healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary bleeding time
time frame: baseline
description: The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.
measure: Visual Analog Scale (VAS)
time frame: 1-7 days after operation
description: The changes in postoperative pain level after the operation
measure: Analgesic consumption
time frame: 1-7 days after operation
description: The changes in the number of painkiller taken to relieve pain after the operation
measure: Completion of epithelization
time frame: Once a week for a month after the operation
description: The epithelization assessed by the peroxide test
arm group label: Periacryl group
arm group type: Experimental
description: Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis
arm group label: Control group
arm group type: Active Comparator
description: Free gingival graft was harvested from palatal region and left to heal without applying periacryl.
intervention type: Procedure
intervention name: Free gingival graft
description: Free gingival graft was harvested from palatal donor site
arm group label: Control group
arm group label: Periacryl group
intervention type: Procedure
intervention name: Cyanoacrylate application
description: Periacyrl was applied on palatal wounds
arm group label: Periacryl group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Ceren Gökmenoğlu
investigator title: Assistant Professor
mesh term: Gingival Recession