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/NCT06035185</url>
    </required_header>
    <id_info>
      <org_study_id>IMU-2023</org_study_id>
      <nct_id>NCT06035185</nct_id>
    </id_info>
    <brief_title>Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion</brief_title>
    <official_title>The Effect of Apical Enlargement on Microbial Load Before and After Passive Ultrasonic Activation in Asymptomatic Teeth Periapical Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to define the role of apical shaping and irrigation&#xD;
        activation on root canal cleanliness. The main questions it aims to answer are:&#xD;
  &#xD;
          -  does the effectiveness of irrigation activation depends on apical shaping?&#xD;
  &#xD;
          -  can a similar success be achieved by increasing apical shaping without irrigation&#xD;
             activation Participants will [describe the main tasks participants will be asked to do,&#xD;
             treatments they'll be given and use bullets if it is more than 2 items].&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to evaluate the effect of apical enlargement with two different&#xD;
        diameters on the intraradicular microbiota of teeth with chronic apical periodontitis lesion&#xD;
        before and after passive ultrasonic irrigation activation using ddPCR analysis in vivo.The&#xD;
        study was planned as a randomized controlled clinical trial. We are planning to include 24&#xD;
        patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic&#xD;
        Clinic with the need for root canal treatment, with asymptomatic chronic apical&#xD;
        periodontitis. 24 patients will randomly be assigned to two groups according to the apical&#xD;
        shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the&#xD;
        teeth will be done with paper cones in three steps during the root canal treatment: 1.&#xD;
        Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first&#xD;
        microbiological sample (S1) from the root canal after the initial file reaches the working&#xD;
        length. 3. The second microbiological sample (S2) from the root canal after the shaping and&#xD;
        irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the&#xD;
        root canal after the irrigation activation in the root canal is finished.The samples will be&#xD;
        sent to the genetic analysis laboratory for further analysis in the cold chain using a&#xD;
        Droplet Digital PCR.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>apical shaping size</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>does apical shaping size affect the microbial load in the root canal after shaping and irrigation finishes? microbial load after two different apical shaping size will be compared between two groups. Droplet Digital PCR will be used to measure and compare the microbial load within the root canal before and after irrigation protocol in each group to measure this outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>irrigation activation</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>does irrigation activation affect the microbial load in the root canal? microbial load after chemomechanical cleaning of the root canal and after the irrigation activation will be compared. Droplet Digital PCR will be used to measure microbial load before after irrigation activation in each canal to see its effect on reduction fo microbial load within the root canal.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the effect of apical shaping in irrigation activation</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>does apical size affect the irrigation activation? the microbial load after chemomechanical cleaning of the root canal and after irrigation activation will be compared between two groups (with different apical shaping size) to analyse the effect of apical shaping on irrigation activation. Droplet Digital PCR results before and after irrigation activation in root canals with different apical size will be compared to measure this outcome.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Root Canal Infection</condition>
    <condition>Periapical Diseases</condition>
    <condition>Periapical; Infection</condition>
    <condition>Endodontic Disease</condition>
    <arm_group>
      <arm_group_label>Group 1- One Curve Mini 25/0.4</arm_group_label>
      <description>Root canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #25/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2- One Curve Mini 35/0.4</arm_group_label>
      <description>Root canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #35/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>apical shaping size</intervention_name>
      <description>24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR.</description>
      <arm_group_label>Group 1- One Curve Mini 25/0.4</arm_group_label>
      <arm_group_label>Group 2- One Curve Mini 35/0.4</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          24 patients who was referred to the Istanbul Medipol University Faculty of Dentistry&#xD;
          Endodontic Clinic with the need for root canal treatment, with asymptomatic chronic apical&#xD;
          periodontitis, witj clinical and radiographic findings. The study will be carried out in&#xD;
          Istanbul Medipol University Faculty of Dentistry Endodontic Clinic, and patients with&#xD;
          appropriate criteria will be informed about the treatment to be performed and their consent&#xD;
          will be obtained. In this observational type study, patients treated by the same physician&#xD;
          will be followed.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between the ages of 18-65&#xD;
  &#xD;
            -  Patients complying with the ASA1 and ASA2 classification (American Society of&#xD;
               Anesthesiology)&#xD;
  &#xD;
            -  Patients who has molar teeth with radiolucent lesions in the periapical region&#xD;
  &#xD;
            -  The volunteer himself/herself or his/her legal representative wants to participate in&#xD;
               the research by signing the 'Voluntary Consent Form'.&#xD;
  &#xD;
            -  Being able to tolerate the treatment physically and mentally&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have taken antibiotics/corticosteroids in the last 3 months&#xD;
  &#xD;
            -  Patients with systemic disease&#xD;
  &#xD;
            -  Teeth that cannot be properly isolated with a rubber dam&#xD;
  &#xD;
            -  Teeth without coronal sealing,&#xD;
  &#xD;
            -  Teeth with periodontal pocket depth&gt;4 mm and teeth with crown / root fracture.&#xD;
  &#xD;
            -  Individuals who continue or are considering starting orthodontic treatment during the&#xD;
               research&#xD;
  &#xD;
            -  Pregnant and lactating individuals&#xD;
  &#xD;
            -  The volunteer himself/herself or his/her legal representative does not want to&#xD;
               participate in the research by signing the 'Voluntary Consent Form'.&#xD;
  &#xD;
            -  Teeth that are damaged enough to require post-core treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tan Firat Eyüboglu, PhD, JSD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Medipol University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tan Firat Eyüboglu</last_name>
      <phone>+905304636059</phone>
      <email>tfeyuboglu@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul Medipol University School of Dentistry</name>
        <address>
          <city>Istanbul</city>
          <zip>34083</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>Tan Firat Eyuboglu</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>apical shaping</keyword>
    <keyword>Droplet Digital PCR</keyword>
    <keyword>irrigation activation</keyword>
    <keyword>microbial load</keyword>
    <keyword>root canal cleanliness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Dental Pulp Diseases</mesh_term>
      <mesh_term>Periapical Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>due to regulatory reasons the participant data will not be shared.</ipd_description>
    </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/NCT06035185
  org study id: IMU-2023
  nct id: NCT06035185
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to define the role of apical shaping and irrigation
        activation on root canal cleanliness. The main questions it aims to answer are:
  
          -  does the effectiveness of irrigation activation depends on apical shaping?
  
          -  can a similar success be achieved by increasing apical shaping without irrigation
             activation Participants will [describe the main tasks participants will be asked to do,
             treatments they'll be given and use bullets if it is more than 2 items].
  The aim of this study is to evaluate the effect of apical enlargement with two different
        diameters on the intraradicular microbiota of teeth with chronic apical periodontitis lesion
        before and after passive ultrasonic irrigation activation using ddPCR analysis in vivo.The
        study was planned as a randomized controlled clinical trial. We are planning to include 24
        patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic
        Clinic with the need for root canal treatment, with asymptomatic chronic apical
        periodontitis. 24 patients will randomly be assigned to two groups according to the apical
        shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the
        teeth will be done with paper cones in three steps during the root canal treatment: 1.
        Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first
        microbiological sample (S1) from the root canal after the initial file reaches the working
        length. 3. The second microbiological sample (S2) from the root canal after the shaping and
        irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the
        root canal after the irrigation activation in the root canal is finished.The samples will be
        sent to the genetic analysis laboratory for further analysis in the cold chain using a
        Droplet Digital PCR.
  observational model: Case-Control
  time perspective: Prospective
  measure: apical shaping size
  time frame: through study completion, an average of 1 year
  description: does apical shaping size affect the microbial load in the root canal after shaping and irrigation finishes? microbial load after two different apical shaping size will be compared between two groups. Droplet Digital PCR will be used to measure and compare the microbial load within the root canal before and after irrigation protocol in each group to measure this outcome.
  measure: irrigation activation
  time frame: through study completion, an average of 1 year
  description: does irrigation activation affect the microbial load in the root canal? microbial load after chemomechanical cleaning of the root canal and after the irrigation activation will be compared. Droplet Digital PCR will be used to measure microbial load before after irrigation activation in each canal to see its effect on reduction fo microbial load within the root canal.
  measure: the effect of apical shaping in irrigation activation
  time frame: through study completion, an average of 1 year
  description: does apical size affect the irrigation activation? the microbial load after chemomechanical cleaning of the root canal and after irrigation activation will be compared between two groups (with different apical shaping size) to analyse the effect of apical shaping on irrigation activation. Droplet Digital PCR results before and after irrigation activation in root canals with different apical size will be compared to measure this outcome.
  arm group label: Group 1- One Curve Mini 25/0.4
  description: Root canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #25/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls.
  arm group label: Group 2- One Curve Mini 35/0.4
  description: Root canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #35/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls.
  intervention type: Procedure
  intervention name: apical shaping size
  description: 24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR.
  arm group label: Group 1- One Curve Mini 25/0.4
  arm group label: Group 2- One Curve Mini 35/0.4
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tan Firat Eyüboglu, PhD, JSD
  role: Principal Investigator
  affiliation: Istanbul Medipol University Hospital
  last name: Tan Firat Eyüboglu
  phone: +905304636059
  email: tfeyuboglu@yahoo.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: Tan Firat Eyuboglu
  investigator title: Associate Professor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Dental Pulp Diseases
  mesh term: Periapical Diseases
  sharing ipd: No
  ipd description: due to regulatory reasons the participant data will not be shared.