<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/NCT03032094</url>
  </required_header>
  <id_info>
    <org_study_id>AAAN2667</org_study_id>
    <nct_id>NCT03032094</nct_id>
  </id_info>
  <brief_title>Connective Tissue Grafting for Single Tooth Recession &amp; the Impact of the Thickness of the Palatal Harvest Tissue</brief_title>
  <official_title>Connective Tissue Grafting for Single Tooth Recession Defects &amp; the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
      The purpose of this study is to test if the thickness of the graft taken from the roof of the&#xD;
      mouth, has a significant effect on the amount of attached tissue and the amount of root&#xD;
      coverage that are attained when treating a single tooth with gingival recession.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the study is to determine if the thickness of a tissue graft taken from the roof&#xD;
      of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the&#xD;
      root coverage, the health of the resulting tissue, as well as postoperative pain as reported&#xD;
      by the patient. Connective tissue grafts will be harvested in different thicknesses, and&#xD;
      results of the procedures will be compared. Qualified subjects will undergo a root coverage&#xD;
      procedure, after random assignment to one of the groups. Regular recall visits to monitor&#xD;
      healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects&#xD;
      will be asked to fill out patient response forms regarding pain and other symptoms at these&#xD;
      visits. Photographs will be taken.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Root coverage</measure>
    <time_frame>Upto 3 months</time_frame>
    <description>Amount of root coverage attained in millimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Root coverage</measure>
    <time_frame>Upto 3 months</time_frame>
    <description>Amount of root coverage attained in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>width of keratinized tissue</measure>
    <time_frame>Upto 3 months</time_frame>
    <description>Amount of zone of keratinized tissue attained in millimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>width of keratinized tissue</measure>
    <time_frame>Upto 3 months</time_frame>
    <description>Amount of zone of keratinized tissue attained in percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>thickness of keratinized tissue</measure>
    <time_frame>Upto 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of erythema and edema</measure>
    <time_frame>Upto 3 months</time_frame>
    <description>patient reported outcome of amount of erythema and edema in number of days postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of erythema and edema</measure>
    <time_frame>Upto 3 months</time_frame>
    <description>patient reported outcome of duration of erythema and edema in number of days postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>1mm thick graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>connective tissue graft of 1mm thickness</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2mm thick graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>connective tissue graft of 2mm thickness</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>connective tissue graft</intervention_name>
    <description>palatal connective tissue graft to attain root coverage</description>
    <arm_group_label>1mm thick graft</arm_group_label>
    <arm_group_label>2mm thick graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt;18 years old&#xD;
&#xD;
          2. Absence of active periodontal disease&#xD;
&#xD;
          3. Single tooth (premolars and anterior teeth) with Miller class I or II gingival&#xD;
             recession &gt;= 2mm&#xD;
&#xD;
          4. Detectable Cemento-Enamel Junction (CEJ) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smokers (&gt;10 cigarettes/ per day)&#xD;
&#xD;
          2. Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c &gt;7%)&#xD;
&#xD;
          3. Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)&#xD;
&#xD;
          4. Medication known to cause gingival enlargement&#xD;
&#xD;
          5. Patients taking anticoagulants with an international normalized ratio (INR) &gt;2.5&#xD;
&#xD;
          6. Long-term (&gt;2 weeks) use of antibiotics in the past 3 months&#xD;
&#xD;
          7. Pregnant or attempting to get pregnant&#xD;
&#xD;
          8. Sites with probing depth &gt; 4mm&#xD;
&#xD;
          9. Recession adjacent to an edentulous area&#xD;
&#xD;
         10. Frenal and muscle attachment that encroach on the marginal gingiva&#xD;
&#xD;
             a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)&#xD;
&#xD;
         11. History of periodontal surgical treatment of the involved sites&#xD;
&#xD;
         12. Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth&#xD;
&#xD;
         13. Teeth with pulpal pathology&#xD;
&#xD;
         14. Severe teeth malposition and open contacts&#xD;
&#xD;
         15. Planned orthodontic treatment to commence within 1 year following procedure&#xD;
&#xD;
         16. Parafunctional habits -&#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>
  <overall_official>
    <last_name>Evanthia Lalla, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Evanthia Lalla</investigator_full_name>
    <investigator_title>Professor of Dental Medicine (Periodontics)</investigator_title>
  </responsible_party>
  <keyword>Gingival Recession</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>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/NCT03032094
org study id: AAAN2667
nct id: NCT03032094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test if the thickness of the graft taken from the roof of the
      mouth, has a significant effect on the amount of attached tissue and the amount of root
      coverage that are attained when treating a single tooth with gingival recession.
The goal of the study is to determine if the thickness of a tissue graft taken from the roof
      of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the
      root coverage, the health of the resulting tissue, as well as postoperative pain as reported
      by the patient. Connective tissue grafts will be harvested in different thicknesses, and
      results of the procedures will be compared. Qualified subjects will undergo a root coverage
      procedure, after random assignment to one of the groups. Regular recall visits to monitor
      healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects
      will be asked to fill out patient response forms regarding pain and other symptoms at these
      visits. Photographs will be taken.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Root coverage
time frame: Upto 3 months
description: Amount of root coverage attained in millimeters
measure: Root coverage
time frame: Upto 3 months
description: Amount of root coverage attained in percentage
measure: width of keratinized tissue
time frame: Upto 3 months
description: Amount of zone of keratinized tissue attained in millimeters
measure: width of keratinized tissue
time frame: Upto 3 months
description: Amount of zone of keratinized tissue attained in percentage
measure: thickness of keratinized tissue
time frame: Upto 3 months
measure: amount of erythema and edema
time frame: Upto 3 months
description: patient reported outcome of amount of erythema and edema in number of days postoperatively
measure: duration of erythema and edema
time frame: Upto 3 months
description: patient reported outcome of duration of erythema and edema in number of days postoperatively
arm group label: 1mm thick graft
arm group type: Active Comparator
description: connective tissue graft of 1mm thickness
arm group label: 2mm thick graft
arm group type: Active Comparator
description: connective tissue graft of 2mm thickness
intervention type: Procedure
intervention name: connective tissue graft
description: palatal connective tissue graft to attain root coverage
arm group label: 1mm thick graft
arm group label: 2mm thick graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Evanthia Lalla, DDS
role: Principal Investigator
affiliation: Columbia University
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Evanthia Lalla
investigator title: Professor of Dental Medicine (Periodontics)
mesh term: Gingival Recession
sharing ipd: Undecided