<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/NCT02986191</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-Perio-01-2016</org_study_id>
    <nct_id>NCT02986191</nct_id>
  </id_info>
  <brief_title>The Use of Mucograft® to Treat Gingival Recession</brief_title>
  <official_title>Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Twenty patients with gingival recession will be enrolled in this trial. Gingival recession&#xD;
      will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while&#xD;
      on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.&#xD;
&#xD;
      Patients will be followed for 3 and 6 months by measuring the clinical indexes and&#xD;
      statistical analyses will be performed to compare the results and to assess the success of&#xD;
      Mucograft®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many surgical techniques have used to treat gingival recession such aas repositioned flaps,&#xD;
      autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts&#xD;
      like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft®&#xD;
      (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue&#xD;
      regeneration and considered the ideal solution to autogenous soft tissue grafts and it&#xD;
      provides an ideal matrix for blood vessel and soft tissue ingrowth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Clinical Attachment Level Index</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
    <description>Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Probing Depth</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
    <description>Probing depth is going to be measuring using a specific tool (UNC-15 probe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival Recession</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
    <description>Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival Biotype</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
    <description>Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Root Coverage Index</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
    <description>The amount of root exposure will be measured and compared to the total length of the root</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resistance to Muscular Pull</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
    <description>The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Color Match Index</measure>
    <time_frame>Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shrinkage index at three months</measure>
    <time_frame>Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shrinkage index at six months</measure>
    <time_frame>Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>Mucograft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One side of the mouth will be subjected to Mucograft in this split-mouth study design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Connective tissue graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The opposite side of the mouth will be subjected to a connective tissue graft.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mucograft</intervention_name>
    <description>This method of grafting will be used to treat the gingival recession using coronally advanced flaps.</description>
    <arm_group_label>Mucograft</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Connective Tissue Graft</intervention_name>
    <description>This will be used in the traditional manner to correct gingival recession</description>
    <arm_group_label>Connective tissue graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of Type I or II (Miller Classification) of gingival recession&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  Presence of any systematic diseases can affect the periodontal surgery.&#xD;
&#xD;
          -  Subjects with significant moderate to severe periodontal disease.&#xD;
&#xD;
          -  Patients under orthodontic treatment&#xD;
&#xD;
          -  Presence of restorative materials (e.g. crown)&#xD;
&#xD;
          -  Effectiveness of frenum&#xD;
&#xD;
          -  Subjects have failed to maintain good plaque control.&#xD;
&#xD;
          -  Subjects having previous surgical treatment for covering the recession in the chosen&#xD;
             area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haydar Barakat, DDS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD Student in Periodontics, University of Damascus Dental School, Damascus, Syria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Suleiman Dayoub, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Periodontics, Department of Peridontics, Univ. of Damascus Dental School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Periodontics, University of Damascus Dental School</name>
      <address>
        <city>Damascus</city>
        <zip>DM20AM18</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Herford AS, Akin L, Cicciu M, Maiorana C, Boyne PJ. Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects. J Oral Maxillofac Surg. 2010 Jul;68(7):1463-70. doi: 10.1016/j.joms.2010.02.054. Epub 2010 Apr 22.</citation>
    <PMID>20417009</PMID>
  </reference>
  <reference>
    <citation>Nevins M, Nevins ML, Kim SW, Schupbach P, Kim DM. The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):367-73.</citation>
    <PMID>21837302</PMID>
  </reference>
  <reference>
    <citation>Rocchietta I, Schupbach P, Ghezzi C, Maschera E, Simion M. Soft tissue integration of a porcine collagen membrane: an experimental study in pigs. Int J Periodontics Restorative Dent. 2012 Feb;32(1):e34-40.</citation>
    <PMID>22254233</PMID>
  </reference>
  <reference>
    <citation>Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.</citation>
    <PMID>21721988</PMID>
  </reference>
  <reference>
    <citation>Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.</citation>
    <PMID>23050490</PMID>
  </reference>
  <reference>
    <citation>McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.</citation>
    <PMID>24597764</PMID>
  </reference>
  <reference>
    <citation>McGuire MK, Scheyer ET. Long-Term Results Comparing Xenogeneic Collagen Matrix and Autogenous Connective Tissue Grafts With Coronally Advanced Flaps for Treatment of Dehiscence-Type Recession Defects. J Periodontol. 2016 Mar;87(3):221-7. doi: 10.1902/jop.2015.150386. Epub 2015 Oct 15.</citation>
    <PMID>26469812</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 3, 2018</last_update_submitted>
  <last_update_submitted_qc>February 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gingival graft</keyword>
  <keyword>free gingival graft</keyword>
  <keyword>coronally advanced flap</keyword>
  <keyword>reduced keratinized gingiva</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_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/NCT02986191
org study id: UDDS-Perio-01-2016
nct id: NCT02986191
lead sponsor: 
has dmc: Yes
Twenty patients with gingival recession will be enrolled in this trial. Gingival recession
      will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while
      on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

      Patients will be followed for 3 and 6 months by measuring the clinical indexes and
      statistical analyses will be performed to compare the results and to assess the success of
      Mucograft®.
Many surgical techniques have used to treat gingival recession such aas repositioned flaps,
      autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts
      like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft®
      (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue
      regeneration and considered the ideal solution to autogenous soft tissue grafts and it
      provides an ideal matrix for blood vessel and soft tissue ingrowth.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Clinical Attachment Level Index
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
description: Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.
measure: Change in Probing Depth
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
description: Probing depth is going to be measuring using a specific tool (UNC-15 probe).
measure: Change in Gingival Recession
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
description: Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.
measure: Change in Gingival Biotype
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
description: Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).
measure: Change in Root Coverage Index
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
description: The amount of root exposure will be measured and compared to the total length of the root
measure: Change in Resistance to Muscular Pull
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
description: The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.
measure: Change in Color Match Index
time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
measure: Shrinkage index at three months
time frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.
measure: Shrinkage index at six months
time frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.
arm group label: Mucograft
arm group type: Experimental
description: One side of the mouth will be subjected to Mucograft in this split-mouth study design.
arm group label: Connective tissue graft
arm group type: Active Comparator
description: The opposite side of the mouth will be subjected to a connective tissue graft.
intervention type: Procedure
intervention name: Mucograft
description: This method of grafting will be used to treat the gingival recession using coronally advanced flaps.
arm group label: Mucograft
intervention type: Procedure
intervention name: Connective Tissue Graft
description: This will be used in the traditional manner to correct gingival recession
arm group label: Connective tissue graft
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Haydar Barakat, DDS MSc
role: Principal Investigator
affiliation: PhD Student in Periodontics, University of Damascus Dental School, Damascus, Syria
last name: Suleiman Dayoub, DDS MSc PhD
role: Study Director
affiliation: Associate Professor of Periodontics, Department of Peridontics, Univ. of Damascus Dental School
facility: 
country: Syrian Arab Republic
citation: Herford AS, Akin L, Cicciu M, Maiorana C, Boyne PJ. Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects. J Oral Maxillofac Surg. 2010 Jul;68(7):1463-70. doi: 10.1016/j.joms.2010.02.054. Epub 2010 Apr 22.
PMID: 20417009
citation: Nevins M, Nevins ML, Kim SW, Schupbach P, Kim DM. The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):367-73.
PMID: 21837302
citation: Rocchietta I, Schupbach P, Ghezzi C, Maschera E, Simion M. Soft tissue integration of a porcine collagen membrane: an experimental study in pigs. Int J Periodontics Restorative Dent. 2012 Feb;32(1):e34-40.
PMID: 22254233
citation: Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.
PMID: 21721988
citation: Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
PMID: 23050490
citation: McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.
PMID: 24597764
citation: McGuire MK, Scheyer ET. Long-Term Results Comparing Xenogeneic Collagen Matrix and Autogenous Connective Tissue Grafts With Coronally Advanced Flaps for Treatment of Dehiscence-Type Recession Defects. J Periodontol. 2016 Mar;87(3):221-7. doi: 10.1902/jop.2015.150386. Epub 2015 Oct 15.
PMID: 26469812
responsible party type: Sponsor
mesh term: Gingival Recession
sharing ipd: No