xml: <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/NCT06028867</url>
    </required_header>
    <id_info>
      <org_study_id>121-29</org_study_id>
      <nct_id>NCT06028867</nct_id>
    </id_info>
    <brief_title>Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis</brief_title>
    <official_title>Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Catania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Catania</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Sodium DNA has several properties that may be beneficial in the management of bacterial&#xD;
        biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the&#xD;
        antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine&#xD;
        0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients&#xD;
        with stage III or IV periodontitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sodium DNA has several properties that may be beneficial in the management of bacterial&#xD;
        biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the&#xD;
        antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine&#xD;
        0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients&#xD;
        with stage III or IV periodontitis. The study was designed as a double-blind randomized&#xD;
        controlled trial (RCT) with three parallel groups of individuals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 24, 2020</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>
      <intervention_model_description>The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Sealed envelopes</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Subgingival biofilm</measure>
      <time_frame>2 weeks</time_frame>
      <description>Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>Chlorhexidine 0,12% + Sodium DNA mouthwash</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chlorhexidine 0,20% mouthwash</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients are treated with a mouthwash containing Chlorhexidine 0,20%</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo mouthwash</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients are treated with a placebo mouthwash</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Non-surgical periodontal treatment</intervention_name>
      <description>Subgingival biofilm ultrasonic debridement</description>
      <arm_group_label>Chlorhexidine 0,12% + Sodium DNA mouthwash</arm_group_label>
      <arm_group_label>Chlorhexidine 0,20% mouthwash</arm_group_label>
      <arm_group_label>Placebo mouthwash</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017&#xD;
          criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6&#xD;
               months.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Systemic diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gaetano Prof. Isola, PhD</last_name>
      <phone>+39-095-378-2453</phone>
      <email>gaetano.isola@unict.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>AOU Policlinico G. Rodolico</name>
        <address>
          <city>Catania</city>
          <zip>95124</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Isola, DDS</last_name>
        <phone>+3909537800</phone>
        <email>gaetano.isola@unict.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Catania</investigator_affiliation>
      <investigator_full_name>Gaetano Isola</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028867
  org study id: 121-29
  nct id: NCT06028867
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sodium DNA has several properties that may be beneficial in the management of bacterial
        biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the
        antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine
        0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients
        with stage III or IV periodontitis.
  Sodium DNA has several properties that may be beneficial in the management of bacterial
        biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the
        antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine
        0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients
        with stage III or IV periodontitis. The study was designed as a double-blind randomized
        controlled trial (RCT) with three parallel groups of individuals.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: Sealed envelopes
  measure: Subgingival biofilm
  time frame: 2 weeks
  description: Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction
  arm group label: Chlorhexidine 0,12% + Sodium DNA mouthwash
  arm group type: Experimental
  description: Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA
  arm group label: Chlorhexidine 0,20% mouthwash
  arm group type: Active Comparator
  description: Patients are treated with a mouthwash containing Chlorhexidine 0,20%
  arm group label: Placebo mouthwash
  arm group type: Placebo Comparator
  description: Patients are treated with a placebo mouthwash
  intervention type: Procedure
  intervention name: Non-surgical periodontal treatment
  description: Subgingival biofilm ultrasonic debridement
  arm group label: Chlorhexidine 0,12% + Sodium DNA mouthwash
  arm group label: Chlorhexidine 0,20% mouthwash
  arm group label: Placebo mouthwash
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gaetano Prof. Isola, PhD
  phone: +39-095-378-2453
  email: gaetano.isola@unict.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Catania
  investigator full name: Gaetano Isola
  investigator title: Researcher
  mesh term: Periodontitis
  sharing ipd: No