<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/NCT04403503</url>
  </required_header>
  <id_info>
    <org_study_id>Cyanoacrylate</org_study_id>
    <nct_id>NCT04403503</nct_id>
  </id_info>
  <brief_title>The Influence of Tissue Adhesive to Palatal Donor Site Healing.</brief_title>
  <official_title>The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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>
      CTG was harvested from 21 patients in each group. Donor site was treated with either GS&#xD;
      (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and&#xD;
      primary bleeding time were recorded intraoperatively. Patients recorded the quantity of&#xD;
      analgesics (QA) taken, presence of secondary bleeding (SB) and pain perception (PP) daily for&#xD;
      first postoperative week. Sensation loss (SL), color match (CM), epithelization level (EL)&#xD;
      were evaluated at days 7, 14, 21 and 28.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>One author (H.G.K.) randomly assigned the patients, with 1:1 allocation ratio, into GS and GS+CY groups by making simple randomization without blocking (computer-generated randomization scheme) (Figure 1). Number-labeled opaque envelopes containing the name of assigned method were used for allocation concealment. The surgical procedures were carried out by (B.T.Y.) whereas another author (E.C.) acquired the intra- and post-operative data. No information regarding to the applied hemostatic was given to the patients to preserve the patient blinding.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Donor site pain perception (PP)</measure>
    <time_frame>first week</time_frame>
    <description>Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary bleeding time (PBT)</measure>
    <time_frame>during surgery</time_frame>
    <description>Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft height (GH)</measure>
    <time_frame>during surgery</time_frame>
    <description>Dimensions were measured with periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft width (GW)</measure>
    <time_frame>during surgery</time_frame>
    <description>Dimensions were measured with periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft thickness (GT)</measure>
    <time_frame>during surgery</time_frame>
    <description>Dimensions were measured with periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working time (WT)</measure>
    <time_frame>during surgery</time_frame>
    <description>Harvesting process was recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of analgesics (QA)</measure>
    <time_frame>first week</time_frame>
    <description>Patients recorded the quantity of analgesics (QA) taken</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary bleeding (SB)</measure>
    <time_frame>first week</time_frame>
    <description>Patients recorded presence/absence of secondary bleeding (SB) (yes or no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensation loss (SL)</measure>
    <time_frame>first week, second week , third week, fourth week.</time_frame>
    <description>Sensation loss (SL) was scored as none, medium or severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Color match (CM)</measure>
    <time_frame>first week, second week, third week, fourth week.</time_frame>
    <description>Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epithelization level (EL)</measure>
    <time_frame>first week, second week, third week, fourth week.</time_frame>
    <description>Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Donor Site Complication</condition>
  <arm_group>
    <arm_group_label>Gelatine Sponge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gelatine sponge +Cyanoacrylate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]</intervention_name>
    <description>Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)</description>
    <arm_group_label>Gelatine Sponge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyanoacrylate, Isobutyl</intervention_name>
    <description>Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).</description>
    <arm_group_label>Gelatine sponge +Cyanoacrylate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥18;&#xD;
&#xD;
          -  PPS indication that needs CTG in anterior mandible;&#xD;
&#xD;
          -  stable periodontium after phase I therapy;&#xD;
&#xD;
          -  full-mouth plaque and bleeding scores &lt;15%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous palatal harvesting history;&#xD;
&#xD;
          -  unstable endodontic conditions;&#xD;
&#xD;
          -  tooth mobility at surgical site;&#xD;
&#xD;
          -  systemic disease;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  use of medications with potential adverse effects to periodontal tissues&#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>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Gencay Keceli</investigator_full_name>
    <investigator_title>Assoc. Prof. Dr.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombin</mesh_term>
    <mesh_term>Gelatin Sponge, Absorbable</mesh_term>
  </intervention_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/NCT04403503
org study id: Cyanoacrylate
nct id: NCT04403503
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
CTG was harvested from 21 patients in each group. Donor site was treated with either GS
      (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and
      primary bleeding time were recorded intraoperatively. Patients recorded the quantity of
      analgesics (QA) taken, presence of secondary bleeding (SB) and pain perception (PP) daily for
      first postoperative week. Sensation loss (SL), color match (CM), epithelization level (EL)
      were evaluated at days 7, 14, 21 and 28.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: One author (H.G.K.) randomly assigned the patients, with 1:1 allocation ratio, into GS and GS+CY groups by making simple randomization without blocking (computer-generated randomization scheme) (Figure 1). Number-labeled opaque envelopes containing the name of assigned method were used for allocation concealment. The surgical procedures were carried out by (B.T.Y.) whereas another author (E.C.) acquired the intra- and post-operative data. No information regarding to the applied hemostatic was given to the patients to preserve the patient blinding.
measure: Donor site pain perception (PP)
time frame: first week
description: Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)
measure: Primary bleeding time (PBT)
time frame: during surgery
description: Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT).
measure: Graft height (GH)
time frame: during surgery
description: Dimensions were measured with periodontal probe
measure: Graft width (GW)
time frame: during surgery
description: Dimensions were measured with periodontal probe
measure: Graft thickness (GT)
time frame: during surgery
description: Dimensions were measured with periodontal probe
measure: Working time (WT)
time frame: during surgery
description: Harvesting process was recorded
measure: Quantity of analgesics (QA)
time frame: first week
description: Patients recorded the quantity of analgesics (QA) taken
measure: Secondary bleeding (SB)
time frame: first week
description: Patients recorded presence/absence of secondary bleeding (SB) (yes or no).
measure: Sensation loss (SL)
time frame: first week, second week , third week, fourth week.
description: Sensation loss (SL) was scored as none, medium or severe
measure: Color match (CM)
time frame: first week, second week, third week, fourth week.
description: Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony)
measure: Epithelization level (EL)
time frame: first week, second week, third week, fourth week.
description: Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery
arm group label: Gelatine Sponge
arm group type: Active Comparator
description: After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA)
arm group label: Gelatine sponge +Cyanoacrylate
arm group type: Active Comparator
description: After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group)
intervention type: Drug
intervention name: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]
description: Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)
arm group label: Gelatine Sponge
intervention type: Drug
intervention name: Cyanoacrylate, Isobutyl
description: Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).
arm group label: Gelatine sponge +Cyanoacrylate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Gencay Keceli
investigator title: Assoc. Prof. Dr.
mesh term: Thrombin
mesh term: Gelatin Sponge, Absorbable