xml: <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/NCT05990049</url>
    </required_header>
    <id_info>
      <org_study_id>05-PA-30-V-2/2022.</org_study_id>
      <nct_id>NCT05990049</nct_id>
    </id_info>
    <brief_title>Hyaluronic Acid and Free Gingival Graft Healing</brief_title>
    <official_title>Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Zagreb</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Zagreb</source>
    <oversight_info>
      <has_dmc>No</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>
        This study aims to evaluate the impact of locally applied hyaluronic acid on free gingival&#xD;
        graft wound bed healing and palatal donor site wound healing.&#xD;
  &#xD;
        Forty subjects will be randomly divided in two separate groups. Test group will be treated&#xD;
        with hyaluronic acid during the procedure and the control group without.&#xD;
  &#xD;
        Periodontal parameters and other clinical measurements will be taken on baseline, 7 days&#xD;
        postoperative, 14 days postoperative, 1 month, 3 months and 6 months postoperative.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Free gingival graft is common, simple and predictable surgical procedure. Patients who have&#xD;
        keratinized tissue width less than 2 mm will undergo the surgery after passing the inclusion&#xD;
        criteria together with initial periodontal therapy. Total number of 40 patients will be&#xD;
        divided in two separate groups; test group (hyaluronic acid) and control group based on&#xD;
        random choice.The randomization will be examiner blind.&#xD;
  &#xD;
        After the application of local anaesthesia, surgical procedure will be done in the same&#xD;
        groups equally. In the recipient site, an horizontal incision will be performed on the&#xD;
        mucogingival junction or 1-2 mm above it to include the free marginal gingiva. Partial&#xD;
        thickness flap will be dissected in order to ensure the vascularisation of the graft. The&#xD;
        size of the incision and graft will depend on the keratinized tissue width of the teeth area.&#xD;
  &#xD;
        The graft will be taken from the donor site on the anterior palate in the area of premolars&#xD;
        and molars. The graft will be measured with periodontal probe (UNC-15) in 3 dimensions over&#xD;
        the flat surface and after the harvesting will be put in glass with saline. Donor site will&#xD;
        be sutured using fibrin sponge and non-resorbable sutures. The size of recipient site and&#xD;
        graft will depend on number of teeth with keratinized tissue width less than 2 mm.&#xD;
  &#xD;
        The graft will be positioned on the recipient site and stabilised using non-resorbable suture&#xD;
        performing single sutures and a sling suture around the tooth. The group of patients who will&#xD;
        receive the hyaluronic acid will be treated on donor and recipient site before the suturing,&#xD;
        applied once on the wound bed.&#xD;
  &#xD;
        Postoperatively, patients will be instructed to rinse with 0.12% chlorhexidine digluconate&#xD;
        twice a day. The patients will be asked to keep a diary for 7 days about pain sensations&#xD;
        using VAS scale for donor and recipient site. An analgetic treatment will be prescribed if&#xD;
        needed.&#xD;
  &#xD;
        Recall visits will be 7 and 14 days postoperatively. The 7th day postoperatively will be&#xD;
        removed sutures from donor site, and on 14th day the sutures from the graft and recipient&#xD;
        site.&#xD;
  &#xD;
        Clinical measurements with periodontal indices will be taken on 1, 3, and 6 months follow up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Keratinized tissue gain</measure>
      <time_frame>baseline to 1 month postoperatively</time_frame>
      <description>changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Keratinized tissue gain</measure>
      <time_frame>baseline to 3 months postoperatively</time_frame>
      <description>changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Keratinized tissue gain</measure>
      <time_frame>baseline to 6 months postoperatively</time_frame>
      <description>changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shrinkage of the graft</measure>
      <time_frame>baseline to 1 month postoperatively</time_frame>
      <description>changes of the graft in apico - coronal and mesio-distal dimensions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shrinkage of the graft</measure>
      <time_frame>baseline to 3 months postoperatively</time_frame>
      <description>changes of the graft in apico - coronal and mesio-distal dimensions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shrinkage of the graft</measure>
      <time_frame>baseline to 6 months postoperatively</time_frame>
      <description>changes of the graft in apico - coronal and mesio-distal dimensions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dimensional changes in gingival recessions</measure>
      <time_frame>baseline to 1 month postoperative</time_frame>
      <description>reduction of gingival recessions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dimensional changes in gingival recessions</measure>
      <time_frame>baseline to 3 months postoperative</time_frame>
      <description>reduction of gingival recessions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dimensional changes in gingival recessions</measure>
      <time_frame>baseline to 6 months postoperative</time_frame>
      <description>reduction of gingival recessions</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hyaluronic Acid</condition>
    <condition>Gingival Recession, Localized</condition>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>Hyaluronic acid</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>After the harvesting of the graft from the donor site, the wound will be sutured using only saline to clean the wound.&#xD;
  On the recipient site, before positioning the graft, only saline will be used.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hyadent BG</intervention_name>
      <description>Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)</description>
      <arm_group_label>Hyaluronic acid</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  no systemic disease&#xD;
  &#xD;
            -  healthy&#xD;
  &#xD;
            -  non-smokers&#xD;
  &#xD;
            -  at least one tooth with keratinized tissue width less than 2 mm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  heavy smokers&#xD;
  &#xD;
            -  younger than 18years old&#xD;
  &#xD;
            -  using drugs&#xD;
  &#xD;
            -  allergy on anesthesia&#xD;
  &#xD;
            -  using drugs or alcohol&#xD;
  &#xD;
            -  undergoing chemotherapy&#xD;
  &#xD;
            -  undergoing radiotherapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ana Badovinac, assoc prof</last_name>
      <role>Study Director</role>
      <affiliation>School of Dental Medicine University of Zagreb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ana Badovinac</last_name>
      <phone>+38598413512</phone>
      <email>badovinac@sfzg.hr</email>
    </overall_contact>
    <location>
      <facility>
        <name>School of Dental Medicine University of Zagreb</name>
        <address>
          <city>Zagreb</city>
          <zip>10000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ana Badovinac</last_name>
        <phone>098413512</phone>
        <email>badovinac@sfzg.hr</email>
      </contact>
      <contact_backup>
        <last_name>Marcela Daria Balic</last_name>
        <email>balic.marcela@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Zagreb</investigator_affiliation>
      <investigator_full_name>Ana Badovinac</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>keratinized tissue width</keyword>
    <keyword>shrinkage</keyword>
    <keyword>hyaluronic acid</keyword>
    <keyword>free gingival graft</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingival Recession</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990049
  org study id: 05-PA-30-V-2/2022.
  nct id: NCT05990049
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the impact of locally applied hyaluronic acid on free gingival
        graft wound bed healing and palatal donor site wound healing.
  
        Forty subjects will be randomly divided in two separate groups. Test group will be treated
        with hyaluronic acid during the procedure and the control group without.
  
        Periodontal parameters and other clinical measurements will be taken on baseline, 7 days
        postoperative, 14 days postoperative, 1 month, 3 months and 6 months postoperative.
  Free gingival graft is common, simple and predictable surgical procedure. Patients who have
        keratinized tissue width less than 2 mm will undergo the surgery after passing the inclusion
        criteria together with initial periodontal therapy. Total number of 40 patients will be
        divided in two separate groups; test group (hyaluronic acid) and control group based on
        random choice.The randomization will be examiner blind.
  
        After the application of local anaesthesia, surgical procedure will be done in the same
        groups equally. In the recipient site, an horizontal incision will be performed on the
        mucogingival junction or 1-2 mm above it to include the free marginal gingiva. Partial
        thickness flap will be dissected in order to ensure the vascularisation of the graft. The
        size of the incision and graft will depend on the keratinized tissue width of the teeth area.
  
        The graft will be taken from the donor site on the anterior palate in the area of premolars
        and molars. The graft will be measured with periodontal probe (UNC-15) in 3 dimensions over
        the flat surface and after the harvesting will be put in glass with saline. Donor site will
        be sutured using fibrin sponge and non-resorbable sutures. The size of recipient site and
        graft will depend on number of teeth with keratinized tissue width less than 2 mm.
  
        The graft will be positioned on the recipient site and stabilised using non-resorbable suture
        performing single sutures and a sling suture around the tooth. The group of patients who will
        receive the hyaluronic acid will be treated on donor and recipient site before the suturing,
        applied once on the wound bed.
  
        Postoperatively, patients will be instructed to rinse with 0.12% chlorhexidine digluconate
        twice a day. The patients will be asked to keep a diary for 7 days about pain sensations
        using VAS scale for donor and recipient site. An analgetic treatment will be prescribed if
        needed.
  
        Recall visits will be 7 and 14 days postoperatively. The 7th day postoperatively will be
        removed sutures from donor site, and on 14th day the sutures from the graft and recipient
        site.
  
        Clinical measurements with periodontal indices will be taken on 1, 3, and 6 months follow up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Keratinized tissue gain
  time frame: baseline to 1 month postoperatively
  description: changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
  measure: Keratinized tissue gain
  time frame: baseline to 3 months postoperatively
  description: changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
  measure: Keratinized tissue gain
  time frame: baseline to 6 months postoperatively
  description: changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
  measure: Shrinkage of the graft
  time frame: baseline to 1 month postoperatively
  description: changes of the graft in apico - coronal and mesio-distal dimensions
  measure: Shrinkage of the graft
  time frame: baseline to 3 months postoperatively
  description: changes of the graft in apico - coronal and mesio-distal dimensions
  measure: Shrinkage of the graft
  time frame: baseline to 6 months postoperatively
  description: changes of the graft in apico - coronal and mesio-distal dimensions
  measure: Dimensional changes in gingival recessions
  time frame: baseline to 1 month postoperative
  description: reduction of gingival recessions
  measure: Dimensional changes in gingival recessions
  time frame: baseline to 3 months postoperative
  description: reduction of gingival recessions
  measure: Dimensional changes in gingival recessions
  time frame: baseline to 6 months postoperative
  description: reduction of gingival recessions
  arm group label: Hyaluronic acid
  arm group type: Active Comparator
  description: During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.
  arm group label: Control
  arm group type: No Intervention
  description: After the harvesting of the graft from the donor site, the wound will be sutured using only saline to clean the wound.
  On the recipient site, before positioning the graft, only saline will be used.
  intervention type: Drug
  intervention name: Hyadent BG
  description: Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
  arm group label: Hyaluronic acid
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ana Badovinac, assoc prof
  role: Study Director
  affiliation: School of Dental Medicine University of Zagreb
  last name: Ana Badovinac
  phone: +38598413512
  email: badovinac@sfzg.hr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Croatia
  responsible party type: Principal Investigator
  investigator affiliation: University of Zagreb
  investigator full name: Ana Badovinac
  investigator title: assistant professor
  mesh term: Gingival Recession
  mesh term: Pain, Postoperative
  sharing ipd: No