<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/NCT03037320</url>
  </required_header>
  <id_info>
    <org_study_id>IGIDSIEC2016NDP28PGHPPAI</org_study_id>
    <nct_id>NCT03037320</nct_id>
  </id_info>
  <brief_title>Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial</brief_title>
  <acronym>CAF and SVIT</acronym>
  <official_title>Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indira Gandhi Institute of Dental Science</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indira Gandhi Institute of Dental Science</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>
      Comparison of Coronally advanced flap with semilunar vestibular incision technique for root&#xD;
      coverage in patients with multiple gingival recession in maxillary teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the subjects attending the OPD department of periodontology, IGIDS and patients will be&#xD;
      selected based on inclusion criteria, informed consent to be obtained from the patients,&#xD;
&#xD;
      Randomization process:&#xD;
&#xD;
        1. Patient to be selected for one of the two procedures by simple random sampling (Lottery&#xD;
           method)&#xD;
&#xD;
        2. Baseline value will be recorded by a calibrated examiner other than the operator&#xD;
&#xD;
        3. The procedure is performed by the operator ( primary investigator)&#xD;
&#xD;
        4. Post op values to be recorded by the calibrated examiner.&#xD;
&#xD;
      Patient to be reviewed at 3 and 6 months Results will be dicussed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</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>amount of root coverage</measure>
    <time_frame>6 months</time_frame>
    <description>root coverage in millimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>width of keratinised gingiva</measure>
    <time_frame>6 months</time_frame>
    <description>increase of width measured in millimeters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Gingival Recession, Generalized</condition>
  <condition>Root Coverage</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>root coverage to be performed by semilunar vestibular incision technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>root coverage by coronally advanced flap</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth</intervention_name>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females subjects of 20-50 years.&#xD;
&#xD;
          -  Patients with multiple gingival recession (2-4 teeth) of class I &amp; II in maxillary&#xD;
             teeth.&#xD;
&#xD;
          -  Patients with well aligned teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with class III &amp;IV gingival recession in maxillary teeth&#xD;
&#xD;
          -  Recession in relation to molars&#xD;
&#xD;
          -  Patients with systemic diseases&#xD;
&#xD;
          -  Medically compromised patients&#xD;
&#xD;
          -  Patient with history of smoking&#xD;
&#xD;
          -  Patients with erosion and root caries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hema pichandi, BDS</last_name>
    <phone>9442804426</phone>
    <phone_ext>+91</phone_ext>
    <email>drhema6119@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pratebha Balu, MDS</last_name>
    <phone>9894360543</phone>
    <phone_ext>+91</phone_ext>
    <email>pratebhabalu@igids.ac.in</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Indira Gandhi Institute of dental sciences</name>
      <address>
        <city>Puducherry</city>
        <zip>607402</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hema pichandi, BDS</last_name>
      <phone>9442804426</phone>
      <phone_ext>+91</phone_ext>
      <email>drhema6119@gamil.com</email>
    </contact>
    <contact_backup>
      <last_name>Pratebha Balu, MDS</last_name>
      <phone>9894360543</phone>
      <phone_ext>+91</phone_ext>
      <email>pratebhabalu@igids.ac.in</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indira Gandhi Institute of Dental Science</investigator_affiliation>
    <investigator_full_name>Dr.Hema.P</investigator_full_name>
    <investigator_title>post graduate student</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/NCT03037320
org study id: IGIDSIEC2016NDP28PGHPPAI
nct id: NCT03037320
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root
      coverage in patients with multiple gingival recession in maxillary teeth.
the subjects attending the OPD department of periodontology, IGIDS and patients will be
      selected based on inclusion criteria, informed consent to be obtained from the patients,

      Randomization process:

        1. Patient to be selected for one of the two procedures by simple random sampling (Lottery
           method)

        2. Baseline value will be recorded by a calibrated examiner other than the operator

        3. The procedure is performed by the operator ( primary investigator)

        4. Post op values to be recorded by the calibrated examiner.

      Patient to be reviewed at 3 and 6 months Results will be dicussed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: amount of root coverage
time frame: 6 months
description: root coverage in millimeters
measure: width of keratinised gingiva
time frame: 6 months
description: increase of width measured in millimeters
arm group label: group A
arm group type: Experimental
description: root coverage to be performed by semilunar vestibular incision technique
arm group label: group B
arm group type: Other
description: root coverage by coronally advanced flap
intervention type: Procedure
intervention name: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth
arm group label: group A
arm group label: group B
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Hema pichandi, BDS
phone: 9442804426
phone ext: +91
email: drhema6119@gmail.com
last name: Pratebha Balu, MDS
phone: 9894360543
phone ext: +91
email: pratebhabalu@igids.ac.in
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Indira Gandhi Institute of Dental Science
investigator full name: Dr.Hema.P
investigator title: post graduate student
mesh term: Gingival Recession
sharing ipd: Undecided