<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/NCT02987231</url>
  </required_header>
  <id_info>
    <org_study_id>UEPJMF 5</org_study_id>
    <nct_id>NCT02987231</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation Effect on Coronally Advanced Flap</brief_title>
  <official_title>Electrical Stimulation Effect on Coronally Advanced Flap for the Treatment of Gingival Recession: Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual Paulista Júlio de Mesquita Filho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual Paulista Júlio de Mesquita Filho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate clinically and through the concentration of&#xD;
      inflammatory markers, the results of 6 months of electrical stimulation associated with&#xD;
      coronally advanced flap for treatment of gingival recession.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, parallel and controlled clinical trial. The population evaluated in&#xD;
      the study was selected at Institute of Science and Technology (ICT), São José dos Campos,&#xD;
      College of Dentistry.&#xD;
&#xD;
      Sixty patients presenting gingival recession will be divided in 2 groups:&#xD;
&#xD;
        -  CAF group: coronally advanced flap for root coverage and sham electrical stimulation&#xD;
&#xD;
        -  CAF+ES group: coronally advanced flap for root coverage plus electrical stimulation.&#xD;
&#xD;
      All surgical procedures were performed by a single operator (MPS). The gingival recession&#xD;
      defects were randomly treated by either the trapezoidal-type of coronally advanced flap plus&#xD;
      connective tissue graft (CAF+CTG). In brief description, CAF treatment was performed by&#xD;
      starting with two divergent releasing incisions lateral to the recessed area. A sulcular&#xD;
      incision was made to unite the releasing incisions and the flap was raised beyond the&#xD;
      mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was&#xD;
      removed from the palate and sutured in position. Sling sutures were placed to stabilize the&#xD;
      flap in a coronal position 2 mm above the cement-enamel junction (CEJ), followed by&#xD;
      interrupted sutures to close the releasing incisions.&#xD;
&#xD;
      For electrical stimulation, a unit consisting of a signal generator (WaveFactoryCo., Ltd.,&#xD;
      Tokyo, Japan), a power supply (KikusuiElectronicsCo., Ltd., Tokyo, Japan) and circuit board&#xD;
      will be used. Conductive electrodes for electrical current application will be applied to the&#xD;
      vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing&#xD;
      incisions and an alternating current of 100 microamperes (μA) at 9 kilohertz (kHz), will be&#xD;
      distributed in order to traverse the operated area. A single application of electrical&#xD;
      stimulation will be given for 120 seconds, once a day for a week. The electric current will&#xD;
      have its visualization optimized through an oscilloscope. Patients randomized to the Control&#xD;
      Group (SHAM) will receive the simulation of the electrical stimulation (ES) process.&#xD;
&#xD;
      Clinical, esthetics, and comfort of patients parameters were assessed at 45 days, 2, 3 and 6&#xD;
      months after the procedure.&#xD;
&#xD;
      Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested&#xD;
      using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical&#xD;
      attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW),&#xD;
      and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to&#xD;
      evaluate the differences within and between groups, followed by a Tukey test for multiple&#xD;
      comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values&#xD;
      &lt; 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney&#xD;
      tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual&#xD;
      analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was&#xD;
      compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were&#xD;
      performed with a T-test. A significance level of 0.05 was adopted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Percentage of Defect Coverage</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Root Coverage Esthetic Score</measure>
    <time_frame>6 months</time_frame>
    <description>The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. The final score ranged from 0-10, higher values were considered better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Gingival Recession, Generalized</condition>
  <arm_group>
    <arm_group_label>CAF + SHAM</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAF + ES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. For electrical stimulation, a unit consisting of a signal generator, a power supply, and circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF</intervention_name>
    <description>Periodontal plastic surgery for root coverage by the trapezoidal flap</description>
    <arm_group_label>CAF + ES</arm_group_label>
    <arm_group_label>CAF + SHAM</arm_group_label>
    <other_name>Periodontal plastic surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ES</intervention_name>
    <description>Local electric stimulation for 120 seconds, once a day for a week</description>
    <arm_group_label>CAF + ES</arm_group_label>
    <other_name>Local electric stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SHAM</intervention_name>
    <description>Simulation of electric stimulation protocol. In Sham stimulation non current will be applied</description>
    <arm_group_label>CAF + SHAM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting Miller class I or II gingival recession in the maxillary canines&#xD;
             or premolars&#xD;
&#xD;
          -  Visible cemento-enamel junction (CEJ) with pulp vitality;&#xD;
&#xD;
          -  Patients presenting no signs of active periodontal disease and full-mouth plaque and&#xD;
             bleeding score ≤20%;&#xD;
&#xD;
          -  Patients older than 18 years old; probing depth ˂3 mm in the included teeth;&#xD;
&#xD;
          -  Patients who agreed to participate and signed an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting systemic problems that would contraindicate the surgical&#xD;
             procedure;&#xD;
&#xD;
          -  Patients taking medications known to interfere with the wound healing process or that&#xD;
             contraindicate the surgical procedure;&#xD;
&#xD;
          -  Smokers or pregnant women;&#xD;
&#xD;
          -  Patients who underwent periodontal surgery in the area of interest;&#xD;
&#xD;
          -  Patients with orthodontic therapy in progress.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro P Santamaria, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICT-UNESP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Felipe Lucas da Silva Neves</name>
      <address>
        <city>Sao Jose dos Campos</city>
        <state>São Paulo</state>
        <zip>12243-700</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.</citation>
    <PMID>17309597</PMID>
  </reference>
  <reference>
    <citation>Tomofuji T, Ekuni D, Azuma T, Irie K, Endo Y, Kasuyama K, Nagayama M, Morita M. Effects of electrical stimulation on periodontal tissue remodeling in rats. J Periodontal Res. 2013 Apr;48(2):177-83. doi: 10.1111/j.1600-0765.2012.01518.x. Epub 2012 Aug 14.</citation>
    <PMID>22891771</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>June 19, 2019</results_first_submitted>
  <results_first_submitted_qc>August 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 7, 2019</results_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</investigator_affiliation>
    <investigator_full_name>Mauro Pedrine Santamaria</investigator_full_name>
    <investigator_title>Assistant Professor</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02987231/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>At clinical site</recruitment_details>
      <pre_assignment_details>The study recruited 66 eligible patients. However, three patients were excluded before assignment to groups. Two recruited patients never presented for treatment and one declined to proceed.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CAF + SHAM</title>
          <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied</description>
        </group>
        <group group_id="P2">
          <title>CAF + ES</title>
          <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
ES: Local electric stimulation for 120 seconds, once a day for a week</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CAF + SHAM</title>
          <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied</description>
        </group>
        <group group_id="B2">
          <title>CAF + ES</title>
          <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
ES: Local electric stimulation for 120 seconds, once a day for a week</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.4" spread="12.68"/>
                    <measurement group_id="B2" value="39.86" spread="10.14"/>
                    <measurement group_id="B3" value="41.13" spread="11.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gingival recession depth</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.09" spread="0.41"/>
                    <measurement group_id="B2" value="3.2" spread="0.58"/>
                    <measurement group_id="B3" value="3.18" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Defect Coverage</title>
        <description>Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAF + SHAM</title>
            <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied</description>
          </group>
          <group group_id="O2">
            <title>CAF + ES</title>
            <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
ES: Local electric stimulation for 120 seconds, once a day for a week</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Defect Coverage</title>
          <description>Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.</description>
          <units>percentage of root coverage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.47" spread="21.19"/>
                    <measurement group_id="O2" value="85.97" spread="17.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Root Coverage Esthetic Score</title>
        <description>The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. The final score ranged from 0-10, higher values were considered better.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAF + SHAM</title>
            <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied</description>
          </group>
          <group group_id="O2">
            <title>CAF + ES</title>
            <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
ES: Local electric stimulation for 120 seconds, once a day for a week</description>
          </group>
        </group_list>
        <measure>
          <title>Root Coverage Esthetic Score</title>
          <description>The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. The final score ranged from 0-10, higher values were considered better.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.03" spread="0.37"/>
                    <measurement group_id="O2" value="7.9" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The period of data collection related to adverse effects started in the immediate postoperative period up to 6 months of follow-up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CAF + SHAM</title>
          <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied</description>
        </group>
        <group group_id="E2">
          <title>CAF + ES</title>
          <description>CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.&#xD;
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap&#xD;
ES: Local electric stimulation for 120 seconds, once a day for a week</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mauro P. Santamaria</name_or_title>
      <organization>Institute of Science and Technology of São José dos Campos (Unesp)</organization>
      <phone>+55 (16) 981937777</phone>
      <email>mauro.santamaria@unesp.br</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02987231
org study id: UEPJMF 5
nct id: NCT02987231
lead sponsor: 
has dmc: No
The objective of this study is to evaluate clinically and through the concentration of
      inflammatory markers, the results of 6 months of electrical stimulation associated with
      coronally advanced flap for treatment of gingival recession.
This is a prospective, parallel and controlled clinical trial. The population evaluated in
      the study was selected at Institute of Science and Technology (ICT), São José dos Campos,
      College of Dentistry.

      Sixty patients presenting gingival recession will be divided in 2 groups:

        -  CAF group: coronally advanced flap for root coverage and sham electrical stimulation

        -  CAF+ES group: coronally advanced flap for root coverage plus electrical stimulation.

      All surgical procedures were performed by a single operator (MPS). The gingival recession
      defects were randomly treated by either the trapezoidal-type of coronally advanced flap plus
      connective tissue graft (CAF+CTG). In brief description, CAF treatment was performed by
      starting with two divergent releasing incisions lateral to the recessed area. A sulcular
      incision was made to unite the releasing incisions and the flap was raised beyond the
      mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was
      removed from the palate and sutured in position. Sling sutures were placed to stabilize the
      flap in a coronal position 2 mm above the cement-enamel junction (CEJ), followed by
      interrupted sutures to close the releasing incisions.

      For electrical stimulation, a unit consisting of a signal generator (WaveFactoryCo., Ltd.,
      Tokyo, Japan), a power supply (KikusuiElectronicsCo., Ltd., Tokyo, Japan) and circuit board
      will be used. Conductive electrodes for electrical current application will be applied to the
      vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing
      incisions and an alternating current of 100 microamperes (μA) at 9 kilohertz (kHz), will be
      distributed in order to traverse the operated area. A single application of electrical
      stimulation will be given for 120 seconds, once a day for a week. The electric current will
      have its visualization optimized through an oscilloscope. Patients randomized to the Control
      Group (SHAM) will receive the simulation of the electrical stimulation (ES) process.

      Clinical, esthetics, and comfort of patients parameters were assessed at 45 days, 2, 3 and 6
      months after the procedure.

      Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested
      using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical
      attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW),
      and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to
      evaluate the differences within and between groups, followed by a Tukey test for multiple
      comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values
      < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney
      tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual
      analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was
      compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were
      performed with a T-test. A significance level of 0.05 was adopted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Defect Coverage
time frame: 6 months
description: Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
measure: Root Coverage Esthetic Score
time frame: 6 months
description: The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. The final score ranged from 0-10, higher values were considered better.
arm group label: CAF + SHAM
arm group type: Sham Comparator
description: CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.
arm group label: CAF + ES
arm group type: Experimental
description: CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. For electrical stimulation, a unit consisting of a signal generator, a power supply, and circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.
intervention type: Procedure
intervention name: CAF
description: Periodontal plastic surgery for root coverage by the trapezoidal flap
arm group label: CAF + ES
arm group label: CAF + SHAM
other name: Periodontal plastic surgery
intervention type: Device
intervention name: ES
description: Local electric stimulation for 120 seconds, once a day for a week
arm group label: CAF + ES
other name: Local electric stimulation
intervention type: Device
intervention name: SHAM
description: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
arm group label: CAF + SHAM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro P Santamaria, PhD
role: Principal Investigator
affiliation: ICT-UNESP
facility: 
country: Brazil
citation: de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
PMID: 17309597
citation: Tomofuji T, Ekuni D, Azuma T, Irie K, Endo Y, Kasuyama K, Nagayama M, Morita M. Effects of electrical stimulation on periodontal tissue remodeling in rats. J Periodontal Res. 2013 Apr;48(2):177-83. doi: 10.1111/j.1600-0765.2012.01518.x. Epub 2012 Aug 14.
PMID: 22891771
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Mauro Pedrine Santamaria
investigator title: Assistant Professor
mesh term: Gingival Recession
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 