<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/NCT03767309</url>
  </required_header>
  <id_info>
    <org_study_id>1788</org_study_id>
    <nct_id>NCT03767309</nct_id>
  </id_info>
  <brief_title>Management of Miller Class I &amp; II Gingival Recession</brief_title>
  <official_title>Management of Miller Class I &amp; II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Halla Gamal Mohammed Esmail</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Management of Miller class I &amp; II gingival recession using coronally advanced flap combined&#xD;
      with conventional de-epithelialized free gingival graft versus coronally advanced flap&#xD;
      combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients&#xD;
      with Miller class I and II gingival recession, there is no difference between coronally&#xD;
      advanced flap with conventional de-epithelialized free gingival graft and coronally advanced&#xD;
      flap with abrasive de-epithelized connective tissue graft in recession depth reduction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Direct Post-operative pain</measure>
    <time_frame>7 days</time_frame>
    <description>Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Indirect Post-operative pain</measure>
    <time_frame>7 days</time_frame>
    <description>Indirectly will be evaluated on the basis of the mean consumption of analgesics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Root Coverage</measure>
    <time_frame>6 months</time_frame>
    <description>CRC evaluated in patients by single operator clinically using a periodontal probe. Root coverage was deemed complete when the gingival margin is at or above the level of CEJ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recession depth.</measure>
    <time_frame>6 months</time_frame>
    <description>Measured from the CEJ to the most apical extension of the gingival margin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Recession Width</measure>
    <time_frame>6 months</time_frame>
    <description>measured at the level of the CEJ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Width Of Keratinized Gingiva</measure>
    <time_frame>6 months</time_frame>
    <description>Measured from the gingival margin to the mucogingival line</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Root Coverage Esthetic Score</measure>
    <time_frame>6 months</time_frame>
    <description>The RES system evaluates five variables 6 months following surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival thickness</measure>
    <time_frame>6 months</time_frame>
    <description>It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical chair time</measure>
    <time_frame>at the time of surgery</time_frame>
    <description>measured by Stop watch</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>coronally advanced flap with abrasive de-epithelized graft.</intervention_name>
    <description>SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>coronally advanced flap with de-epithelized graft.</intervention_name>
    <description>SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Systemically healthy patients.&#xD;
&#xD;
          -  Miller's Class I and II recession defects with recession depth ≥ 2mm.&#xD;
&#xD;
          -  Presence of identifiable cemento-enamel junction (CEJ).&#xD;
&#xD;
          -  Clinical indication and/or patient request for recession coverage.&#xD;
&#xD;
          -  Smoking ≤ 10 cigarettes/day.&#xD;
&#xD;
          -  Cooperative patients able and accept to come for follow up appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Smoking ˃ 10 cigarettes/day.&#xD;
&#xD;
          -  Contraindication for periodontal surgery.&#xD;
&#xD;
          -  Patients with poor oral hygiene.&#xD;
&#xD;
          -  Recession defects associated with caries or restoration as well as&#xD;
&#xD;
          -  Teeth with evidence of a pulpal pathology&#xD;
&#xD;
          -  Molar teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Halla Gamal Mohammed Esmail</investigator_full_name>
    <investigator_title>Dentist</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03767309
org study id: 1788
nct id: NCT03767309
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Management of Miller class I & II gingival recession using coronally advanced flap combined
      with conventional de-epithelialized free gingival graft versus coronally advanced flap
      combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients
      with Miller class I and II gingival recession, there is no difference between coronally
      advanced flap with conventional de-epithelialized free gingival graft and coronally advanced
      flap with abrasive de-epithelized connective tissue graft in recession depth reduction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Direct Post-operative pain
time frame: 7 days
description: Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.
measure: Indirect Post-operative pain
time frame: 7 days
description: Indirectly will be evaluated on the basis of the mean consumption of analgesics
measure: Complete Root Coverage
time frame: 6 months
description: CRC evaluated in patients by single operator clinically using a periodontal probe. Root coverage was deemed complete when the gingival margin is at or above the level of CEJ
measure: Recession depth.
time frame: 6 months
description: Measured from the CEJ to the most apical extension of the gingival margin
measure: Gingival Recession Width
time frame: 6 months
description: measured at the level of the CEJ.
measure: Width Of Keratinized Gingiva
time frame: 6 months
description: Measured from the gingival margin to the mucogingival line
measure: Root Coverage Esthetic Score
time frame: 6 months
description: The RES system evaluates five variables 6 months following surgery
measure: Gingival thickness
time frame: 6 months
description: It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues.
measure: Surgical chair time
time frame: at the time of surgery
description: measured by Stop watch
arm group label: Test group
arm group type: Experimental
description: SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)
arm group label: Control group
arm group type: Active Comparator
description: SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft)
intervention type: Procedure
intervention name: coronally advanced flap with abrasive de-epithelized graft.
description: SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur
arm group label: Test group
intervention type: Procedure
intervention name: coronally advanced flap with de-epithelized graft.
description: SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Halla Gamal Mohammed Esmail
investigator title: Dentist
mesh term: Gingival Recession
sharing ipd: Undecided