<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/NCT03814707</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-09-17</org_study_id>
    <nct_id>NCT03814707</nct_id>
  </id_info>
  <brief_title>Platelet Rich Fibrin VS Hyaloronic Acid in Management of Pain After Harvesting a Free Gingival Graft</brief_title>
  <official_title>Clinical Comparison of Platelet Rich Fibrin Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Wound Healing After Free Gingival Graft Harvesting: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>mostafa soliman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs&#xD;
      platelet rich fibrin in decreasing a postoperative pain following free gingival graft&#xD;
      procedure .&#xD;
&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Patients of both groups will be subjected to:&#xD;
&#xD;
        1. Case history including personal data, medical, surgical history and family history.&#xD;
&#xD;
        2. Clinical Examination.&#xD;
&#xD;
      After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was&#xD;
      prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal&#xD;
      extension.. The free gingival graft extended from the mesial line angle upper 5 and distal&#xD;
      line angle of upper 6 .&#xD;
&#xD;
      The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival&#xD;
      margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to&#xD;
      obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the&#xD;
      graft during the surgery by using an endodontic file then the grafts will be positioned, and&#xD;
      firmly adapted to the bed, and stabilized with simple periosteal sutures.&#xD;
&#xD;
      Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was&#xD;
      introduced by Choukroun &amp; coworkers. PRF requires around 10 ml of blood to be collected from&#xD;
      the forearm of patient without anticoagulant in a glass coated plastic tubes. After&#xD;
      collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12&#xD;
      minutes. After the completion of cycle, the blood become separated into three distinct&#xD;
      layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base&#xD;
      in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with&#xD;
      attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the&#xD;
      palatal donor site and stabilized by criss cross resorbable suture then covered by&#xD;
      periodontal pack&#xD;
&#xD;
      control group Control group: As the intervention group but the palatal wound will receive a&#xD;
      .2% hyaluronic acid gel then covered by periodontal dressing&#xD;
&#xD;
      ..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">June 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>
    <intervention_model_description>Parallel Assignment&#xD;
A randomized clinical trial.&#xD;
Parallel group study.&#xD;
A trial will be carried out in department of periodontology - Faculty of Oral and Dental medicine - Cairo University .&#xD;
Equal randomization : participants with equal probabilities for intervention.&#xD;
Positive controlled : Both groups receiving treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>both the participants and the investigator can't be blinded only outcome assessor will be blinded .</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>post operative pain</measure>
    <time_frame>1 week</time_frame>
    <description>Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wound healing</measure>
    <time_frame>2 months</time_frame>
    <description>Early Wound Healing Index (EHI) , measuring unit Binary (YES/NO)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Topical application 0.2%Hyaluronic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Platelet Rich Fibrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical application of 0.2% hyaluronic acid gel</intervention_name>
    <description>Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting</description>
    <arm_group_label>Topical application 0.2%Hyaluronic Acid</arm_group_label>
    <other_name>gengigel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet rich fibrin</intervention_name>
    <description>Placement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack.</description>
    <arm_group_label>Platelet Rich Fibrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for participants:&#xD;
&#xD;
          -  Patients with mucogingival defects scheduled for free gingival graft&#xD;
&#xD;
          -  Age at least 18 years.&#xD;
&#xD;
          -  Not having any systemic disease that could compromise wound healing&#xD;
&#xD;
          -  No previous periodontal surgery on the experimental sites.&#xD;
&#xD;
        Exclusion Criteria for participants:&#xD;
&#xD;
          -  Systemic diseases that may be a contraindication for any surgeries.&#xD;
&#xD;
          -  Loss of maxillary premolars and molars.&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Smoking&#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>
  <overall_official>
    <last_name>Mona M Shoeib, P.H.D</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mostafa M Soliman, B.D.S</last_name>
    <phone>002-01007034062</phone>
    <email>drshoo_2010@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mona M Shoeib, P.H.D</last_name>
    <phone>002-01223102216</phone>
    <email>monashoeib@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Dental Medicine - Cairo University -</name>
      <address>
        <city>Giza</city>
        <zip>12613</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mostafa M Soliman, B.D.S</last_name>
      <phone>002-01007034062</phone>
      <email>drshoo_2010@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Mona M Shoeib, P.H.D</last_name>
      <phone>002-01223102216</phone>
      <email>monashoeib@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>mostafa soliman</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>gingival recession</keyword>
  <keyword>gingival augmentation</keyword>
  <keyword>free gingival graft</keyword>
  <keyword>platelet rich fibrin in wound healing</keyword>
  <keyword>2 steps free gingival graft</keyword>
  <keyword>hyaluronic acid in wound healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <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/NCT03814707
org study id: CEBD-CU-2018-09-17
nct id: NCT03814707
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs
      platelet rich fibrin in decreasing a postoperative pain following free gingival graft
      procedure .

      .
- Patients of both groups will be subjected to:

        1. Case history including personal data, medical, surgical history and family history.

        2. Clinical Examination.

      After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was
      prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal
      extension.. The free gingival graft extended from the mesial line angle upper 5 and distal
      line angle of upper 6 .

      The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival
      margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to
      obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the
      graft during the surgery by using an endodontic file then the grafts will be positioned, and
      firmly adapted to the bed, and stabilized with simple periosteal sutures.

      Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was
      introduced by Choukroun & coworkers. PRF requires around 10 ml of blood to be collected from
      the forearm of patient without anticoagulant in a glass coated plastic tubes. After
      collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12
      minutes. After the completion of cycle, the blood become separated into three distinct
      layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base
      in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with
      attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the
      palatal donor site and stabilized by criss cross resorbable suture then covered by
      periodontal pack

      control group Control group: As the intervention group but the palatal wound will receive a
      .2% hyaluronic acid gel then covered by periodontal dressing

      ..
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
A randomized clinical trial.
Parallel group study.
A trial will be carried out in department of periodontology - Faculty of Oral and Dental medicine - Cairo University .
Equal randomization : participants with equal probabilities for intervention.
Positive controlled : Both groups receiving treatment.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: both the participants and the investigator can't be blinded only outcome assessor will be blinded .
measure: post operative pain
time frame: 1 week
description: Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst
measure: wound healing
time frame: 2 months
description: Early Wound Healing Index (EHI) , measuring unit Binary (YES/NO)
arm group label: Topical application 0.2%Hyaluronic Acid
arm group type: Active Comparator
description: Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack
arm group label: Platelet Rich Fibrin
arm group type: Experimental
description: Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.
intervention type: Drug
intervention name: Topical application of 0.2% hyaluronic acid gel
description: Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting
arm group label: Topical application 0.2%Hyaluronic Acid
other name: gengigel
intervention type: Biological
intervention name: Platelet rich fibrin
description: Placement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack.
arm group label: Platelet Rich Fibrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mona M Shoeib, P.H.D
role: Study Director
affiliation: Cairo University
last name: Mostafa M Soliman, B.D.S
phone: 002-01007034062
email: drshoo_2010@hotmail.com
last name: Mona M Shoeib, P.H.D
phone: 002-01223102216
email: monashoeib@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: mostafa soliman
investigator title: Principle Investigator
mesh term: Pain, Postoperative
mesh term: Hyaluronic Acid
sharing ipd: No