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/NCT05988359</url>
    </required_header>
    <id_info>
      <org_study_id>WroclawMU4</org_study_id>
      <nct_id>NCT05988359</nct_id>
    </id_info>
    <brief_title>Quantitative Evaluation of Aerosols Produced in the Dental Office</brief_title>
    <official_title>Assessment of Aerosol Quantity Generated During Caries Treat-ment With Er:YAG Laser. A Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wroclaw Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wroclaw Medical University</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>
        Background: Maintaining biosafety in dental practice requires an efficient elimination of&#xD;
        aerosols produced during dental treatment. The objective of this research was to assess the&#xD;
        quantity of aerosols and aerobic bacteria present in the air during the treatment of caries.&#xD;
        Methods: This study was divided into two groups based on the caries treatment method&#xD;
        involving 60 patients with 60 m olar teeth (n=60) in the mandible. Group 1 (n=30) received a&#xD;
        conventional dental turbine W&amp;H Synea TA-98LC (W&amp;H, Bürmoos, Austria), while Group 2 (n=30)&#xD;
        received an Er:YAG laser (LightWalker, Fotona, Slovenia). Measurements of aerosol particles&#xD;
        between 0.3 - 10.0 μm near the operator's mouth were taken using the PC200 laser particle&#xD;
        counter (Trotec GmbH, Schwerin, Germany). The number of aerobic bacteria in the air was&#xD;
        determined using 60 micro-biological plates with a microbiological medium (Columbia Agar with&#xD;
        5% Sheep Blood) and the sedimentation method. A control group G3 was established to measure&#xD;
        the initial aero-sol level and the initial total number of bacteria CFUs (colony-forming&#xD;
        units) before each treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 28, 2021</start_date>
    <completion_date type="Actual">May 4, 2022</completion_date>
    <primary_completion_date type="Actual">April 15, 2022</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>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Aerosols measurment</measure>
      <time_frame>immediately before the procedure</time_frame>
      <description>The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aerosols measurment</measure>
      <time_frame>immediately after the procedure</time_frame>
      <description>The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bacteriological study</measure>
      <time_frame>60 miniutes before the procedure</time_frame>
      <description>The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bacteriological study</measure>
      <time_frame>immediately before the procedure</time_frame>
      <description>The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bacteriological study</measure>
      <time_frame>immediately after the procedure</time_frame>
      <description>The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Aerosol Disease</condition>
    <condition>Caries,Dental</condition>
    <arm_group>
      <arm_group_label>Dental turbine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the first group, G1 (n=30) a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by a dental turbine.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Laser</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the second G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by an Er:YAG laser.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Caries treatment with a dental turbine</intervention_name>
      <description>G1 (n=30) conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.</description>
      <arm_group_label>Dental turbine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Caries treatment with Er:YAG laser</intervention_name>
      <description>G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.</description>
      <arm_group_label>Laser</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - The subjects were chosen for the study under the subsequent inclusion criteria:&#xD;
          occurrence of medium or profound caries on Black class I, ICDAS 3,4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with systematic diseases that can influence the treatment of periodontitis&#xD;
  &#xD;
            -  Patients under or took antibiotics 2 months.&#xD;
  &#xD;
            -  Patients under or took immunosuppressors the last 6 months.&#xD;
  &#xD;
            -  Pregnant or lactating woman.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Oral Surgery Department</name>
        <address>
          <city>Wroclaw</city>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Wroclaw Medical University</investigator_affiliation>
      <investigator_full_name>Jacek Matys</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>laser</keyword>
    <keyword>Er:YAG</keyword>
    <keyword>disinfection</keyword>
    <keyword>bacteria</keyword>
    <keyword>high-volume evacuator</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</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/NCT05988359
  org study id: WroclawMU4
  nct id: NCT05988359
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: Maintaining biosafety in dental practice requires an efficient elimination of
        aerosols produced during dental treatment. The objective of this research was to assess the
        quantity of aerosols and aerobic bacteria present in the air during the treatment of caries.
        Methods: This study was divided into two groups based on the caries treatment method
        involving 60 patients with 60 m olar teeth (n=60) in the mandible. Group 1 (n=30) received a
        conventional dental turbine W&H Synea TA-98LC (W&H, Bürmoos, Austria), while Group 2 (n=30)
        received an Er:YAG laser (LightWalker, Fotona, Slovenia). Measurements of aerosol particles
        between 0.3 - 10.0 μm near the operator's mouth were taken using the PC200 laser particle
        counter (Trotec GmbH, Schwerin, Germany). The number of aerobic bacteria in the air was
        determined using 60 micro-biological plates with a microbiological medium (Columbia Agar with
        5% Sheep Blood) and the sedimentation method. A control group G3 was established to measure
        the initial aero-sol level and the initial total number of bacteria CFUs (colony-forming
        units) before each treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Aerosols measurment
  time frame: immediately before the procedure
  description: The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).
  measure: Aerosols measurment
  time frame: immediately after the procedure
  description: The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).
  measure: Bacteriological study
  time frame: 60 miniutes before the procedure
  description: The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
  measure: Bacteriological study
  time frame: immediately before the procedure
  description: The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
  measure: Bacteriological study
  time frame: immediately after the procedure
  description: The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
  arm group label: Dental turbine
  arm group type: Active Comparator
  description: In the first group, G1 (n=30) a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by a dental turbine.
  arm group label: Laser
  arm group type: Experimental
  description: In the second G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by an Er:YAG laser.
  intervention type: Procedure
  intervention name: Caries treatment with a dental turbine
  description: G1 (n=30) conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.
  arm group label: Dental turbine
  intervention type: Procedure
  intervention name: Caries treatment with Er:YAG laser
  description: G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.
  arm group label: Laser
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Poland
  responsible party type: Principal Investigator
  investigator affiliation: Wroclaw Medical University
  investigator full name: Jacek Matys
  investigator title: Principal Investigator
  mesh term: Dental Caries
  sharing ipd: No