<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/NCT02194023</url>
  </required_header>
  <id_info>
    <org_study_id>PER-ECL-2011-06-NF</org_study_id>
    <nct_id>NCT02194023</nct_id>
  </id_info>
  <brief_title>Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.</brief_title>
  <official_title>Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Internacional de Catalunya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dentaid SL</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitat Internacional de Catalunya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC)&#xD;
      mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield&#xD;
      similar or better clinical results regarding the inhibition of de novo plaque growth compared&#xD;
      to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without&#xD;
      alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula&#xD;
      and 3) that these mouthrinses have no negative microbiological effects, and they control&#xD;
      total bacterial loads.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants with greater reduction of plaque regrowth and side effects.</measure>
    <time_frame>Baseline to 4 days.</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Dental Plaque</condition>
  <condition>Side Effects</condition>
  <arm_group>
    <arm_group_label>Placebo (PCB)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.12%NF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.12% Chlorhexidine digluconate new formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.03%NF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.03% Chlorhexidine digluconate new formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAT (Perio-Aid Treatment)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo: PCB</intervention_name>
    <description>Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.</description>
    <arm_group_label>Placebo (PCB)</arm_group_label>
    <other_name>saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.12%NF</intervention_name>
    <description>Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.</description>
    <arm_group_label>0.12%NF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.03%NF</intervention_name>
    <description>Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.</description>
    <arm_group_label>0.03%NF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PAT</intervention_name>
    <description>Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.</description>
    <arm_group_label>PAT (Perio-Aid Treatment)</arm_group_label>
    <other_name>Perio-Aid Treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-30 years&#xD;
&#xD;
          -  Good overall health without medical history or medications that could interfere with&#xD;
             the study conduct.&#xD;
&#xD;
          -  Minimum of 6 teeth per quadrant.&#xD;
&#xD;
          -  Absence of probing depths ≥4mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to CHX or to CPC.&#xD;
&#xD;
          -  Continuous use of CHX or of any other oral antiseptic in the months prior to the&#xD;
             study.&#xD;
&#xD;
          -  Any adverse medical background or long-term medications that could affect gingival&#xD;
             conditions.&#xD;
&#xD;
          -  Having taken antibiotics in the previous three months.&#xD;
&#xD;
          -  Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al.&#xD;
             1994).&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Smokers of more than 5 cigarettes per day.&#xD;
&#xD;
          -  Orthodontic appliances.&#xD;
&#xD;
          -  Fixed or removable prostheses.&#xD;
&#xD;
          -  Systemic diseases that increase the risk for gingival diseases (diabetes mellitus,&#xD;
             immunosuppression).&#xD;
&#xD;
          -  Severe dental crowding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolina Mor-Reinoso</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat Internacional de Catalunya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UIC dental office, Hospital General de Catalunya</name>
      <address>
        <city>Sant Cugat</city>
        <state>Barcelona</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitat Internacional de Catalunya</investigator_affiliation>
    <investigator_full_name>Carolina Mor</investigator_full_name>
    <investigator_title>Master in periodontics by Universitat Internacional de Catalunya.</investigator_title>
  </responsible_party>
  <keyword>chlorhexidine digluconate</keyword>
  <keyword>gingivitis</keyword>
  <keyword>cetylpyridinium chloride</keyword>
  <keyword>mouthrinse</keyword>
  <keyword>dental plaque</keyword>
  <keyword>de novo</keyword>
  <keyword>in vivo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</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/NCT02194023
org study id: PER-ECL-2011-06-NF
nct id: NCT02194023
lead sponsor: 
collaborator: 
has dmc: Yes
In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC)
      mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield
      similar or better clinical results regarding the inhibition of de novo plaque growth compared
      to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without
      alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula
      and 3) that these mouthrinses have no negative microbiological effects, and they control
      total bacterial loads.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of participants with greater reduction of plaque regrowth and side effects.
time frame: Baseline to 4 days.
arm group label: Placebo (PCB)
arm group type: Placebo Comparator
description: Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water)
arm group label: 0.12%NF
arm group type: Experimental
description: 0.12% Chlorhexidine digluconate new formulation
arm group label: 0.03%NF
arm group type: Experimental
description: 0.03% Chlorhexidine digluconate new formulation
arm group label: PAT (Perio-Aid Treatment)
arm group type: Active Comparator
description: Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)
intervention type: Drug
intervention name: Placebo: PCB
description: Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
arm group label: Placebo (PCB)
other name: saline solution
intervention type: Drug
intervention name: 0.12%NF
description: Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
arm group label: 0.12%NF
intervention type: Drug
intervention name: 0.03%NF
description: Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
arm group label: 0.03%NF
intervention type: Drug
intervention name: PAT
description: Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
arm group label: PAT (Perio-Aid Treatment)
other name: Perio-Aid Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carolina Mor-Reinoso
role: Principal Investigator
affiliation: Universitat Internacional de Catalunya
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universitat Internacional de Catalunya
investigator full name: Carolina Mor
investigator title: Master in periodontics by Universitat Internacional de Catalunya.
mesh term: Dental Plaque