<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/NCT02975024</url>
  </required_header>
  <id_info>
    <org_study_id>3/2013</org_study_id>
    <nct_id>NCT02975024</nct_id>
  </id_info>
  <brief_title>Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hungarian Scientific Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Semmelweis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to&#xD;
      enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes&#xD;
      during wound healing in human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vestibuloplasty is the common name of those procedures designed to widen the zone of attached&#xD;
      gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or&#xD;
      with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently&#xD;
      used surgical techniques, however no data are available, how these graft tissues affect the&#xD;
      microcirculation of the healing gingiva.&#xD;
&#xD;
      LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different&#xD;
      tissues. This new method let us monitor the entire surgical area real-time during the healing&#xD;
      period.&#xD;
&#xD;
      The aim of the present study is to define blood flow patterns, which might characterize the&#xD;
      wound healing of such surgical procedures during the first 6 months of healing in order to&#xD;
      facilitate treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative blood flow changes of the oral mucosa</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Blood flow changes are measured by Laser Speckle Contrast Imager (LSCI) after mandibular vestibuloplasty. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the surgically unaffected surrounding mucosa measurements are calculated. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14, 21, 28 days, and 2, 3, 4, 5, 6 months. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative blood flow changes are compared between the two surgical techniques.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound fluid volume measurement</measure>
    <time_frame>14 days after surgery</time_frame>
    <description>Wound fluid sample is collected using a filter strip to withdraw the fluid around the wound. The filter strip is then inserted into Periotron 8010 instrument to score the volume on the paper. Scores are measured in an arbitrary unit. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14 days. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid changes are compared between the two surgical techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.</measure>
    <time_frame>Pre- and six month postoperative</time_frame>
    <description>Periodontal parameters are evaluated using a periodontal probe and will be expressed in mm. The following will be assessed at each tooth at the surgical site: probing depth, depth and width of recession, papilla height, and width and thickness of the keratinized gingiva. Surgical area is also measured apico-coronally and mesio-distally, during the whole follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid</measure>
    <time_frame>4 days after surgery</time_frame>
    <description>Wound fluid sample for VEGF is collected at the fourth postoperative day. For the quantitative determination of VEGF in samples the Human VEGF Quantikine ELISA Kit will be used. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid level of VEGF (expressed in conc pg/mL) are compared between the two surgical techniques.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Mucogingival Defect</condition>
  <arm_group>
    <arm_group_label>Mucograft</arm_group_label>
    <description>Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a xenogeneic collagen matrix (Mucograft).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>strip gingival graft + Mucograft</arm_group_label>
    <description>Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a strip gingival graft and a xenogeneic collagen matrix (Mucograft). The strip gingival graft is harvested from the patient's palate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser speckle contrast imaging of the oral mucosa</intervention_name>
    <description>Non-invasive method to measure tissue blood perfusion applied for oral mucosa</description>
    <arm_group_label>Mucograft</arm_group_label>
    <arm_group_label>strip gingival graft + Mucograft</arm_group_label>
    <other_name>LSCI Perimed PSI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>wound fluid measurement</intervention_name>
    <description>Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.</description>
    <arm_group_label>Mucograft</arm_group_label>
    <arm_group_label>strip gingival graft + Mucograft</arm_group_label>
    <other_name>Periotron 8010</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>quantitative determination of VEGF</intervention_name>
    <description>For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.</description>
    <arm_group_label>Mucograft</arm_group_label>
    <arm_group_label>strip gingival graft + Mucograft</arm_group_label>
    <other_name>Human VEGF Quantikine ELISA Kit</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Caucasians subjects presenting multiple Miller Class I. and II. gingival recessions&#xD;
        (Multiple Adjacent Recession Type Defects, MARTD) were recruited in the Department of&#xD;
        Periodontology in Semmelweis University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Ages Eligible for Study: 18 Years to 45 Years Genders Eligible for Study: Both Accepts&#xD;
        Healthy Volunteers: Yes&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        • clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front&#xD;
        region&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  heavy smoking&#xD;
&#xD;
          -  general diseases&#xD;
&#xD;
          -  taking medications or having treatments which have an effect on mucosal healing in&#xD;
             general (e.g. steroids, anti-inflammatory drugs)&#xD;
&#xD;
          -  taking any other medications in the last three months (except contraceptives)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janos Vag</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University, Dept. of Conservative Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Janos Vag</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Semmelweis University</investigator_affiliation>
    <investigator_full_name>Dr. Vag Janos</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>mandibular vestibuloplasty</keyword>
  <keyword>wound healing</keyword>
  <keyword>microcirculation</keyword>
  <keyword>Laser Speckle Contrast Imager</keyword>
  <keyword>Mucograft</keyword>
  <keyword>strip gingival graft</keyword>
  <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/NCT02975024
org study id: 3/2013
nct id: NCT02975024
lead sponsor: 
collaborator: 
has dmc: No
Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to
      enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes
      during wound healing in human subjects.
Vestibuloplasty is the common name of those procedures designed to widen the zone of attached
      gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or
      with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently
      used surgical techniques, however no data are available, how these graft tissues affect the
      microcirculation of the healing gingiva.

      LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different
      tissues. This new method let us monitor the entire surgical area real-time during the healing
      period.

      The aim of the present study is to define blood flow patterns, which might characterize the
      wound healing of such surgical procedures during the first 6 months of healing in order to
      facilitate treatment.
observational model: Cohort
time perspective: Prospective
measure: Postoperative blood flow changes of the oral mucosa
time frame: 6 months after surgery
description: Blood flow changes are measured by Laser Speckle Contrast Imager (LSCI) after mandibular vestibuloplasty. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the surgically unaffected surrounding mucosa measurements are calculated. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14, 21, 28 days, and 2, 3, 4, 5, 6 months. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative blood flow changes are compared between the two surgical techniques.
measure: Wound fluid volume measurement
time frame: 14 days after surgery
description: Wound fluid sample is collected using a filter strip to withdraw the fluid around the wound. The filter strip is then inserted into Periotron 8010 instrument to score the volume on the paper. Scores are measured in an arbitrary unit. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14 days. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid changes are compared between the two surgical techniques.
measure: Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.
time frame: Pre- and six month postoperative
description: Periodontal parameters are evaluated using a periodontal probe and will be expressed in mm. The following will be assessed at each tooth at the surgical site: probing depth, depth and width of recession, papilla height, and width and thickness of the keratinized gingiva. Surgical area is also measured apico-coronally and mesio-distally, during the whole follow-up period.
measure: Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid
time frame: 4 days after surgery
description: Wound fluid sample for VEGF is collected at the fourth postoperative day. For the quantitative determination of VEGF in samples the Human VEGF Quantikine ELISA Kit will be used. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid level of VEGF (expressed in conc pg/mL) are compared between the two surgical techniques.
arm group label: Mucograft
description: Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a xenogeneic collagen matrix (Mucograft).
arm group label: strip gingival graft + Mucograft
description: Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a strip gingival graft and a xenogeneic collagen matrix (Mucograft). The strip gingival graft is harvested from the patient's palate.
intervention type: Device
intervention name: laser speckle contrast imaging of the oral mucosa
description: Non-invasive method to measure tissue blood perfusion applied for oral mucosa
arm group label: Mucograft
arm group label: strip gingival graft + Mucograft
other name: LSCI Perimed PSI
intervention type: Device
intervention name: wound fluid measurement
description: Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.
arm group label: Mucograft
arm group label: strip gingival graft + Mucograft
other name: Periotron 8010
intervention type: Device
intervention name: quantitative determination of VEGF
description: For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.
arm group label: Mucograft
arm group label: strip gingival graft + Mucograft
other name: Human VEGF Quantikine ELISA Kit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janos Vag
role: Principal Investigator
affiliation: Semmelweis University, Dept. of Conservative Dentistry
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Semmelweis University
investigator full name: Dr. Vag Janos
investigator title: associate professor
sharing ipd: No