<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/NCT02229669</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1158-9611</org_study_id>
    <nct_id>NCT02229669</nct_id>
  </id_info>
  <brief_title>Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions</brief_title>
  <official_title>Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paulista University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paulista University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compared the clinical outcomes of coronally advanced flap using two different&#xD;
      surgical strategies in the treatment of multiple gingival recessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this split-mouth, randomized controlled trial was to compare the clinical&#xD;
      outcomes of coronally advanced flap (CAF) using two different surgical strategies in the&#xD;
      treatment of multiple gingival recessions. Recessions were randomly treated according to a&#xD;
      split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF&#xD;
      with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC),&#xD;
      clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue&#xD;
      (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months&#xD;
      after treatment. Patient-centered outcomes concerning morbidity and improvement in the&#xD;
      esthetic appearance were recorded using a Visual Analogue Scale (VAS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Marginal gingival recession to 6 months</measure>
    <time_frame>baseline, and at 3 and 6 months post-surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>height of keratinized tissue</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thickness of keratinized tissue</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing deph</measure>
    <time_frame>baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Gingival Diseases</condition>
  <arm_group>
    <arm_group_label>Horizontal incisions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coronally advanced flap was performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oblique incisions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli &amp; De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Horizontal incisions</intervention_name>
    <description>Performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Passive closure of the wound margins without tension was achieved with interrupted coaptation.</description>
    <arm_group_label>Horizontal incisions</arm_group_label>
    <arm_group_label>Oblique incisions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oblique incisions</intervention_name>
    <description>Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli &amp; De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.</description>
    <arm_group_label>Horizontal incisions</arm_group_label>
    <arm_group_label>Oblique incisions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy subjects&#xD;
&#xD;
          -  Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth&#xD;
             (at least three recession-type defects affecting adjacent teeth in each side of the&#xD;
             maxilla).&#xD;
&#xD;
          -  At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) &gt; 3&#xD;
             mm.&#xD;
&#xD;
          -  Full-mouth plaque and bleeding on probing of &lt; 20%.&#xD;
&#xD;
          -  Involved tooth should present tooth vitality, absence of caries, restorations or&#xD;
             extensive non-carious cervical lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of smoking.&#xD;
&#xD;
          -  Antimicrobial and anti-inflammatory therapies in the previous 2 months.&#xD;
&#xD;
          -  Previous mucogingival surgery at the region to be treated&#xD;
&#xD;
          -  Systemic conditions that could affect tissue healing (e.g. diabetes).&#xD;
&#xD;
          -  Use of orthodontic appliances.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzana Pimentel, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paulista University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guilherme Barrella, MS</last_name>
    <role>Study Chair</role>
    <affiliation>Paulista University</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Paulista University</investigator_affiliation>
    <investigator_full_name>Guilherme Barrella</investigator_full_name>
    <investigator_title>MS, DDS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
    <mesh_term>Gingival Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02229669
org study id: U1111-1158-9611
nct id: NCT02229669
lead sponsor: 
has dmc: Yes
This study compared the clinical outcomes of coronally advanced flap using two different
      surgical strategies in the treatment of multiple gingival recessions.
The objective of this split-mouth, randomized controlled trial was to compare the clinical
      outcomes of coronally advanced flap (CAF) using two different surgical strategies in the
      treatment of multiple gingival recessions. Recessions were randomly treated according to a
      split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF
      with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC),
      clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue
      (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months
      after treatment. Patient-centered outcomes concerning morbidity and improvement in the
      esthetic appearance were recorded using a Visual Analogue Scale (VAS).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline in Marginal gingival recession to 6 months
time frame: baseline, and at 3 and 6 months post-surgery
measure: height of keratinized tissue
time frame: Baseline, 3 and 6 months
measure: thickness of keratinized tissue
time frame: baseline, 3 and 6 months
measure: Clinical attachment level
time frame: baseline, 3 and 6 months
measure: Probing deph
time frame: baseline, 3 and 6 months
arm group label: Horizontal incisions
arm group type: Experimental
description: Coronally advanced flap was performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.
arm group label: Oblique incisions
arm group type: Experimental
description: Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
intervention type: Procedure
intervention name: Horizontal incisions
description: Performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Passive closure of the wound margins without tension was achieved with interrupted coaptation.
arm group label: Horizontal incisions
arm group label: Oblique incisions
intervention type: Procedure
intervention name: Oblique incisions
description: Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
arm group label: Horizontal incisions
arm group label: Oblique incisions
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suzana Pimentel, PHD
role: Principal Investigator
affiliation: Paulista University
last name: Guilherme Barrella, MS
role: Study Chair
affiliation: Paulista University
responsible party type: Principal Investigator
investigator affiliation: Paulista University
investigator full name: Guilherme Barrella
investigator title: MS, DDS
mesh term: Gingival Recession
mesh term: Gingival Diseases