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/NCT05976451</url>
    </required_header>
    <id_info>
      <org_study_id>1011</org_study_id>
      <nct_id>NCT05976451</nct_id>
    </id_info>
    <brief_title>Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1</brief_title>
    <official_title>Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study was to evaluate time effect on the clinical&#xD;
        predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue&#xD;
        graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent&#xD;
        gingival recession (MAGR) in recession type one (RT1)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        this study was conducted to evaluate time effect on the clinical predictability of collagen&#xD;
        matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine&#xD;
        whether it is proposed to be an alternative in multiple adjacent gingival recession&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2020</start_date>
    <completion_date type="Actual">March 3, 2023</completion_date>
    <primary_completion_date type="Actual">April 1, 2022</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>interproximal clinical attachment level</measure>
      <time_frame>6-9 months</time_frame>
      <description>measured from CEJ to base of pocket depth by using periodontal prob</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing pocket depth (PPD)</measure>
      <time_frame>6-9 months</time_frame>
      <description>from gingival margin to pocket depth measured by mm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recession depth</measure>
      <time_frame>6-9 months</time_frame>
      <description>measure from CEJ to gingival margin by mm</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Keratinized tissue width</measure>
      <time_frame>6-9 months</time_frame>
      <description>from free gingival groove to MGJ</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">22</enrollment>
    <condition>Gingival Recession Types One(RT1)</condition>
    <arm_group>
      <arm_group_label>collagen matrix</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>connective tissue graft (CTG)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>melatonin with collagen matrix</intervention_name>
      <description>(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)</description>
      <arm_group_label>collagen matrix</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>connective tissue graft (CTG)</intervention_name>
      <description>control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)</description>
      <arm_group_label>connective tissue graft (CTG)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR&#xD;
               depth ≥2 mm,&#xD;
  &#xD;
            -  patients &gt;18 years old,&#xD;
  &#xD;
            -  Full mouth plaque index score &lt;20%&#xD;
  &#xD;
            -  Systemically and periodontally healthy patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Patients with periodontitis stage III and IV were previous surgical treatment of GR,&#xD;
  &#xD;
            -  Pregnant or breastfeeding women; P&#xD;
  &#xD;
            -  Patients with para-functional habits or any source of occlusal trauma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <state>Al Qahirah</state>
          <zip>11566</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>mahetab mohamed abdel el wahab</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingival Recession</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melatonin</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05976451
  org study id: 1011
  nct id: NCT05976451
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The primary objective of this study was to evaluate time effect on the clinical
        predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue
        graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent
        gingival recession (MAGR) in recession type one (RT1)
  this study was conducted to evaluate time effect on the clinical predictability of collagen
        matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine
        whether it is proposed to be an alternative in multiple adjacent gingival recession
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: interproximal clinical attachment level
  time frame: 6-9 months
  description: measured from CEJ to base of pocket depth by using periodontal prob
  measure: Probing pocket depth (PPD)
  time frame: 6-9 months
  description: from gingival margin to pocket depth measured by mm
  measure: Recession depth
  time frame: 6-9 months
  description: measure from CEJ to gingival margin by mm
  measure: Keratinized tissue width
  time frame: 6-9 months
  description: from free gingival groove to MGJ
  arm group label: collagen matrix
  arm group type: Experimental
  description: melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)
  arm group label: connective tissue graft (CTG)
  arm group type: Active Comparator
  description: connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)
  intervention type: Combination Product
  intervention name: melatonin with collagen matrix
  description: (CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)
  arm group label: collagen matrix
  intervention type: Combination Product
  intervention name: connective tissue graft (CTG)
  description: control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)
  arm group label: connective tissue graft (CTG)
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: mahetab mohamed abdel el wahab
  investigator title: lecturer
  mesh term: Gingival Recession
  mesh term: Melatonin