<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/NCT02192060</url>
  </required_header>
  <id_info>
    <org_study_id>RVOppermann01</org_study_id>
    <nct_id>NCT02192060</nct_id>
  </id_info>
  <brief_title>Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation</brief_title>
  <official_title>Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic&#xD;
      of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival&#xD;
      biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop&#xD;
      mechanical supragingiva biofilm removal measures for 96h following a complete scaling and&#xD;
      polishing of the tooth surfaces. During this period they will be asked to rinse for one&#xD;
      minute with a slurry of either a triclosan containing dentifice or a control without&#xD;
      triclosan. Every 24h the presence of deposits will be registered with special atention to the&#xD;
      presence of a plaque free zone between the apical border of the deposits and the gingival&#xD;
      margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and&#xD;
      presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring&#xD;
      early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006).&#xD;
      The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated&#xD;
      for significance. Sample size was calculated taking the results from the study o MALISKA, AN&#xD;
      (2006) as reference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Plaque Free Zone</measure>
    <time_frame>24 hours</time_frame>
    <description>The presence of scores 0, 1 or 2 of the index &quot;Plaque Free Zone&quot; will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Dental Plaque</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using of a suspension containing Triclosan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Using of a suspension without Triclosan or other active ingredient</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test - Using of a suspension containing Triclosan</intervention_name>
    <description>The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.</description>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control - Using of a suspension without Triclosan</intervention_name>
    <description>The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age from 18 years;&#xD;
&#xD;
          -  non-smokers;&#xD;
&#xD;
          -  have good general health;&#xD;
&#xD;
          -  present at least 20 natural teeth in the mouth, including the incisors, canines and&#xD;
             premolars without restorations, crowns, gingival recession, anatomic defects,&#xD;
             gingivitis e/or periodontitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  positive history of using antibiotic e/or anti-inflammatory drugs in the month&#xD;
             previous to the initial consultation;&#xD;
&#xD;
          -  positive history of allergies at using Triclosan;&#xD;
&#xD;
          -  pregnant or lactating patients;&#xD;
&#xD;
          -  patients in use of fixed orthodontic appliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rui V. Oppermann, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dentistry Faculty, Federal University of Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 13, 2013</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Rui Vicente Oppermann</investigator_full_name>
    <investigator_title>DDS, PhD</investigator_title>
  </responsible_party>
  <keyword>Biofilm</keyword>
  <keyword>Triclosan</keyword>
  <keyword>Crossover</keyword>
  <keyword>Clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triclosan</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/NCT02192060
org study id: RVOppermann01
nct id: NCT02192060
lead sponsor: 
has dmc: No
The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic
      of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival
      biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).
This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop
      mechanical supragingiva biofilm removal measures for 96h following a complete scaling and
      polishing of the tooth surfaces. During this period they will be asked to rinse for one
      minute with a slurry of either a triclosan containing dentifice or a control without
      triclosan. Every 24h the presence of deposits will be registered with special atention to the
      presence of a plaque free zone between the apical border of the deposits and the gingival
      margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and
      presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring
      early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006).
      The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated
      for significance. Sample size was calculated taking the results from the study o MALISKA, AN
      (2006) as reference.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Presence of Plaque Free Zone
time frame: 24 hours
description: The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).
arm group label: Test
arm group type: Experimental
description: Using of a suspension containing Triclosan
arm group label: Control
arm group type: Placebo Comparator
description: Using of a suspension without Triclosan or other active ingredient
intervention type: Other
intervention name: Test - Using of a suspension containing Triclosan
description: The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.
arm group label: Test
intervention type: Other
intervention name: Control - Using of a suspension without Triclosan
description: The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rui V. Oppermann, DDS, PhD
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Rui Vicente Oppermann
investigator title: DDS, PhD
mesh term: Dental Plaque
mesh term: Triclosan