<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/NCT02259543</url>
  </required_header>
  <id_info>
    <org_study_id>018/2010</org_study_id>
    <nct_id>NCT02259543</nct_id>
  </id_info>
  <brief_title>Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage</brief_title>
  <official_title>Conditioning of Root Surfaces With Citric Acid and Tetracycline for Different Application Times Improves the Outcomes of Root Coverage by Subepithelial Connective Tissue Graft: a Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the effects of the application of a citric acid +&#xD;
      tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the&#xD;
      outcomes of treatment of Miller's class I or II recession defects by subepithelial connective&#xD;
      tissue graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients showing Miller's class I or II recession defects requiring root coverage were&#xD;
      recruited to participate in the study. All patients were submitted to non surgical&#xD;
      periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene&#xD;
      instruction in order to reduce/eliminate gingival inflammation. After that, patients were&#xD;
      randomly allocated to three different treatment groups based on root conditioning: G0- no&#xD;
      conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds.&#xD;
      Allocation was defined by a software. Root coverage was performed by subepithelial connective&#xD;
      tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated&#xD;
      root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12&#xD;
      months post-operatively by a blinded trained expertise different from operator and included:&#xD;
      pocket depth, recession height, clinical attachment level, width of keratinized gingiva,&#xD;
      sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also&#xD;
      investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment&#xD;
      according to visual analogic scale (VAS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of root coverage (%REC)</measure>
    <time_frame>one year</time_frame>
    <description>Percentage of root coverage obtained at 1 year after procedure. Represented by the difference of baseline recession height and final recession height divided by baseline recession height multiplied by 100 (in percentage).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reduction in recession height</measure>
    <time_frame>one year</time_frame>
    <description>Linear difference between final recession height and baseline recession height, measured by a millimeter periodontal probe as the distance from cementum-enamel junction and gingival margin at the center of recession defect (in mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>increase in the width of keratinized gingiva</measure>
    <time_frame>one year</time_frame>
    <description>Linear difference between final and baseline width of keratinized gingiva. Measured with a millimeter periodontal problem as the distance from gingival margin to mucogingival junction (in mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gain in clinical attachment level</measure>
    <time_frame>one year</time_frame>
    <description>Linear difference between final and baseline clinical attachment level. Measured with a millimeter periodontal probe as the distance from cementum-enamel junction and the bottom of the sulcus or pocket (in mm).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>reduction in probing depth</measure>
    <time_frame>one year</time_frame>
    <description>Linear difference of final and baseline probing pocket measurements. Measured with a millimeter periodontal probe as the distance between gingival margin and the bottom of the sulcus or pocket (in mm).</description>
  </other_outcome>
  <other_outcome>
    <measure>reduction in bleeding index</measure>
    <time_frame>one year</time_frame>
    <description>Difference in the presence (score 1) or absence (0) of bleeding on probing, up to 10 seconds after removal of the probe from the sulcus (index; percentage)</description>
  </other_outcome>
  <other_outcome>
    <measure>reduction in plaque index</measure>
    <time_frame>one year</time_frame>
    <description>Difference in the presence (score 1) or absence (score 0) of plaque accumulation, visually determined (index; percentage)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>G0</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Root decontamination performed by scaling and root planing followed by rinsing with saline solution during the treatment of recession defects by subepithelial connective tissue graft (SCTG). Control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G90</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root conditioning with citric acid+tetracycline solution (1:1) for 90 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G180</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root conditioning with citric acid+tetracycline solution (1:1) for 180 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root conditioning with citric acid+tetracycline solution</intervention_name>
    <description>Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft</description>
    <arm_group_label>G180</arm_group_label>
    <arm_group_label>G90</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of Miller's class I or II recession extending 2-5 mm apical to CEJ requiring&#xD;
             root coverage for the following reasons: esthetics, progression of recession or&#xD;
             hypersensitivity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers;&#xD;
&#xD;
          -  pregnants;&#xD;
&#xD;
          -  routine use of anti-convulsants, anti-hypertensive or cyclosporine;&#xD;
&#xD;
          -  uncontrolled systemic diseases (e.g.: diabetes mellitus);&#xD;
&#xD;
          -  systemic conditions that requires antibiotic prophylaxis (e.g.: history of bacterial&#xD;
             endocarditis; rheumatoid arthritis; prosthetic valves);&#xD;
&#xD;
          -  antibiotics, steroidal or non-steroidal anti-inflammatory intake in the 6-month&#xD;
             previous period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>João Paulo C Barros, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Graduation student</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics</name>
      <address>
        <city>Bauru</city>
        <state>São Paulo</state>
        <zip>17012-912</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 5, 2014</last_update_submitted>
  <last_update_submitted_qc>October 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Adriana Campos Passanezi SantAna</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>gingival recession</keyword>
  <keyword>soft tissue</keyword>
  <keyword>root biomodification</keyword>
  <keyword>root coverage</keyword>
  <keyword>citric acid</keyword>
  <keyword>tetracycline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetracycline</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
  </intervention_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/NCT02259543
org study id: 018/2010
nct id: NCT02259543
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to investigate the effects of the application of a citric acid +
      tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the
      outcomes of treatment of Miller's class I or II recession defects by subepithelial connective
      tissue graft.
Adult patients showing Miller's class I or II recession defects requiring root coverage were
      recruited to participate in the study. All patients were submitted to non surgical
      periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene
      instruction in order to reduce/eliminate gingival inflammation. After that, patients were
      randomly allocated to three different treatment groups based on root conditioning: G0- no
      conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds.
      Allocation was defined by a software. Root coverage was performed by subepithelial connective
      tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated
      root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12
      months post-operatively by a blinded trained expertise different from operator and included:
      pocket depth, recession height, clinical attachment level, width of keratinized gingiva,
      sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also
      investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment
      according to visual analogic scale (VAS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: percentage of root coverage (%REC)
time frame: one year
description: Percentage of root coverage obtained at 1 year after procedure. Represented by the difference of baseline recession height and final recession height divided by baseline recession height multiplied by 100 (in percentage).
measure: reduction in recession height
time frame: one year
description: Linear difference between final recession height and baseline recession height, measured by a millimeter periodontal probe as the distance from cementum-enamel junction and gingival margin at the center of recession defect (in mm).
measure: increase in the width of keratinized gingiva
time frame: one year
description: Linear difference between final and baseline width of keratinized gingiva. Measured with a millimeter periodontal problem as the distance from gingival margin to mucogingival junction (in mm).
measure: gain in clinical attachment level
time frame: one year
description: Linear difference between final and baseline clinical attachment level. Measured with a millimeter periodontal probe as the distance from cementum-enamel junction and the bottom of the sulcus or pocket (in mm).
measure: reduction in probing depth
time frame: one year
description: Linear difference of final and baseline probing pocket measurements. Measured with a millimeter periodontal probe as the distance between gingival margin and the bottom of the sulcus or pocket (in mm).
measure: reduction in bleeding index
time frame: one year
description: Difference in the presence (score 1) or absence (0) of bleeding on probing, up to 10 seconds after removal of the probe from the sulcus (index; percentage)
measure: reduction in plaque index
time frame: one year
description: Difference in the presence (score 1) or absence (score 0) of plaque accumulation, visually determined (index; percentage)
arm group label: G0
arm group type: No Intervention
description: Root decontamination performed by scaling and root planing followed by rinsing with saline solution during the treatment of recession defects by subepithelial connective tissue graft (SCTG). Control group.
arm group label: G90
arm group type: Active Comparator
description: Root conditioning with citric acid+tetracycline solution (1:1) for 90 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).
arm group label: G180
arm group type: Active Comparator
description: Root conditioning with citric acid+tetracycline solution (1:1) for 180 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).
intervention type: Other
intervention name: Root conditioning with citric acid+tetracycline solution
description: Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft
arm group label: G180
arm group label: G90
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: João Paulo C Barros, Master
role: Principal Investigator
affiliation: Graduation student
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Adriana Campos Passanezi SantAna
investigator title: Associate Professor
mesh term: Gingival Recession
mesh term: Tetracycline
mesh term: Citric Acid
mesh term: Sodium Citrate