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/NCT06005545</url>
    </required_header>
    <id_info>
      <org_study_id>EC_5301_V1.0_CIP</org_study_id>
      <nct_id>NCT06005545</nct_id>
    </id_info>
    <brief_title>A Study to Compare Various Root Canal Cleaning Devices Based on Cavitation,Ultrasonic and Conventional Methods.</brief_title>
    <official_title>A Comparative Evaluation of Effectiveness in Root Canal Debridement Using Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lumendo AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lumendo AG</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the effectiveness of various root canal&#xD;
        cleaning devices based on the principle of cavitation, ultrasonics, and conventional methods&#xD;
        in a normal healthy adult population aged between 18 to 75 years requiring root canal&#xD;
        treatment.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Effectiveness of the cleaning mechanism&#xD;
  &#xD;
          -  Evaluate the safety of use of the device. Participants will be provided root canal&#xD;
             treatment. Participants will be asked to record their post-operative pain levels in a&#xD;
             Patient Pain diary. The healing rate of the lesion will be examined at follow-up visits&#xD;
             using intraoral X-rays. At the end of the study, a statistical analysis of the clinical&#xD;
             outcomes of the root canal treatment will be examined and evaluated in every group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study title: &quot;A Comparative Evaluation of Effectiveness in Root Canal Debridement using&#xD;
        Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A&#xD;
        Randomized Controlled Clinical Trial&quot;.&#xD;
  &#xD;
        Study Design: This is a prospective, 3-arm randomized, non-blinded, single-center pivotal&#xD;
        clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean&#xD;
        device with 2 comparator arms.&#xD;
  &#xD;
        Primary objective: To test the effectiveness of the Endoclean device for root canal&#xD;
        debridement up to 12-month follow-up.&#xD;
  &#xD;
        Secondary objective: To test the extended effectiveness and safety of the Endoclean device up&#xD;
        to a 24-month follow-up.&#xD;
  &#xD;
        Inclusion/Exclusion Criteria:&#xD;
  &#xD;
          1. Inclusion Criteria&#xD;
  &#xD;
             •Patients aged between 18-75 years with ASA (American Society of Anesthesiologists)&#xD;
             classification 1 and 2.&#xD;
  &#xD;
             ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body mass index) under 30,&#xD;
             a non-smoking patient with good exercise tolerance.&#xD;
  &#xD;
             ASA 2: A patient with mild systemic disease. Example: Patient with no functional&#xD;
             limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI&#xD;
             under 35, frequent social drinker, or cigarette smoker).&#xD;
  &#xD;
               -  Patients who agreed to participate and who have signed the informed consent.&#xD;
  &#xD;
               -  Patients presenting with symptomatic and/or asymptomatic apical periodontitis and&#xD;
                  radiographic evidence of apical periodontitis in anterior or posterior teeth larger&#xD;
                  than 1.5 mm in diameter.&#xD;
  &#xD;
               -  Mature tooth with closed apices&#xD;
  &#xD;
               -  Tooth that has never been treated with root canal therapy.&#xD;
  &#xD;
          2. Exclusion Criteria:&#xD;
  &#xD;
               -  Patients, who have pre-existing health or oral conditions that placed them at risk&#xD;
                  during the trial.&#xD;
  &#xD;
               -  Patients with generalized untreated periodontal disease.&#xD;
  &#xD;
               -  Patients with a history of analgesic intake within the past 3 days or antibiotics&#xD;
                  in the last 1 month.&#xD;
  &#xD;
               -  Uncooperative patients&#xD;
  &#xD;
               -  Teeth with immature apices, root resorption, or requiring extensive prosthetic&#xD;
                  rehabilitation.&#xD;
  &#xD;
               -  Teeth that cannot be made functional nor restored or difficult to access teeth with&#xD;
                  no importance (wisdom teeth)&#xD;
  &#xD;
               -  Teeth with insufficient periodontal support&#xD;
  &#xD;
               -  Teeth with poor prognosis, for example due to deep root caries, large root&#xD;
                  resorption or open apex cases&#xD;
  &#xD;
               -  Fractured teeth&#xD;
  &#xD;
               -  Local anatomical factors such as an inaccessible root end&#xD;
  &#xD;
               -  Presence of fractured instrument in the root canal&#xD;
  &#xD;
               -  Pregnant women&#xD;
  &#xD;
               -  Patients unable to understand the study procedure.&#xD;
  &#xD;
        Number of Participants:&#xD;
  &#xD;
        Total number of participants = 109 subjects Arm 1: 40 subjects Arm 2: 40 subjects Arm 3: 29&#xD;
        subjects Test device: Endoclean (Lumendo AG): hydraulic cavitation cleaning device Control&#xD;
        device 1: Passive ultrasonic irrigation (PUI) Control device 2: Rotary files with standard&#xD;
        NaOCl irrigation Study duration: 2-3 years The results of the Endoclean group shall be&#xD;
        compared to data gathered from the comparator device groups and results shall be presented in&#xD;
        the clinical investigation report.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2025</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>This is a prospective, 3- arm randomized, non-blinded, single center pivotal clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean device with 2 comparator arms.&#xD;
  Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06, Arm 2: Endoclean (EC) group; shaping up to WL with 20.06; EC application tip kept 3mm short of WL, irrigation protocol with NaOCl (sodium hypochlorite) Arm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary effectiveness endpoint</measure>
      <time_frame>12 months</time_frame>
      <description>Successful healing of periapical lesion up to 12 months post-procedure where success is defined as completely healed or healing lesion with absence of clinical symptoms.&#xD;
  Healing is assessed by measuring the reduction in periapical lesion radiolucency, up to 12 months post-procedure, using the PAI (periapical index score).&#xD;
  The absence of clinical symptoms is defined as:&#xD;
  The patient had no discomfort in treated tooth&#xD;
  The patient had no percussive pain during the examination in treated tooth</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety endpoint</measure>
      <time_frame>1 month</time_frame>
      <description>Freedom from postoperative pain up to 7 days of follow-up period (24 hours, 48 hours, 72 hours, 7 days and 1 month). Pain is measured by Visual Analogue Scale (VAS) assessment.The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. The VAS is used to assist individuals to determine pain levels, who may not be accustomed to rating their pain on other types of scales, such as a numeric rating scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary effectiveness endpoints</measure>
      <time_frame>24 months</time_frame>
      <description>Successful healing of periapical lesion up to 24 months post-procedure. Long-term effectiveness success shall be defined as a continued reduction or complete absence of periapical lesion radiolucency at 24m FU since the procedure with no clinical symptoms (i.e no discomfort in treated tooth and no percussive pain during examination)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">109</enrollment>
    <condition>Apical Periodontitis</condition>
    <arm_group>
      <arm_group_label>Passive Ultrasonic Irrigation group (PUI)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Endoclean group (EC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Arm 2: Endoclean (EC) group; shaping up to WL with 20.06; EC application tip kept 3mm short of WL, irrigation protocol with NaOCl (sodium hypochlorite)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Arm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Passive Ultrasonic Irrigation (PUI) group</intervention_name>
      <description>Passive ultrasonic irrigation is the current golden standard in root canal cleaning and irrigation devices. It is used after root canal shaping using manual or rotary instruments. It uses sodium hypochlorite which is mobilized in the canal using ultrasonic non-cutting tips to clean, debride, disinfect, and prepare the root canal for obturation.</description>
      <arm_group_label>Passive Ultrasonic Irrigation group (PUI)</arm_group_label>
      <other_name>Ultrasonic group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Endoclean (EC) group</intervention_name>
      <description>Endoclean is a novel device that uses hydraulic inertial cavitation with the help of pressure and saline solution to debride the root canal after minimal shaping using manual or rotary shaping instruments. It is used to effectively clean, debride and prepare the root canal before obturation in the root canal treatment procedure.</description>
      <arm_group_label>Endoclean group (EC)</arm_group_label>
      <other_name>Cavitation group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conventional group</intervention_name>
      <description>Conventional root canal preparation uses manual or rotary files along with manual irrigation using syringes and irrigant solutions like sodium hypochlorite or EDTA to clean, debride and prepare the root canal for obturation.</description>
      <arm_group_label>Conventional Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          •Patients aged between 18-75 years with ASA (American Society of Anesthesiologists)&#xD;
          classification 1 and 2.&#xD;
  &#xD;
          ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body mass index) under 30, a&#xD;
          non-smoking patient with good exercise tolerance.&#xD;
  &#xD;
          ASA 2: A patient with mild systemic disease. Example: Patient with no functional&#xD;
          limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI&#xD;
          under 35, frequent social drinker, or cigarette smoker).&#xD;
  &#xD;
            -  Patients who agreed to participate and who have signed the informed consent.&#xD;
  &#xD;
            -  Patients presenting with symptomatic and/or asymptomatic apical periodontitis and&#xD;
               radiographic evidence of apical periodontitis in anterior or posterior teeth larger&#xD;
               than 1.5 mm in diameter.&#xD;
  &#xD;
            -  Mature tooth with closed apices&#xD;
  &#xD;
            -  Tooth that has never been treated with root canal therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients, who have pre-existing health or oral conditions that placed them at risk&#xD;
               during the trial.&#xD;
  &#xD;
            -  Patients with generalized untreated periodontal disease.&#xD;
  &#xD;
            -  Patients with a history of analgesic intake within the past 3 days or antibiotics in&#xD;
               the last 1 month.&#xD;
  &#xD;
            -  Uncooperative patients&#xD;
  &#xD;
            -  Teeth with immature apices, root resorption, or requiring extensive prosthetic&#xD;
               rehabilitation.&#xD;
  &#xD;
            -  Teeth that cannot be made functional nor restored or difficult to access teeth with no&#xD;
               importance (wisdom teeth)&#xD;
  &#xD;
            -  Teeth with insufficient periodontal support&#xD;
  &#xD;
            -  Teeth with poor prognosis, for example due to deep root caries, large root resorption&#xD;
               or open apex cases&#xD;
  &#xD;
            -  Fractured teeth&#xD;
  &#xD;
            -  Local anatomical factors such as an inaccessible root end.&#xD;
  &#xD;
            -  Presence of fractured instrument in the root canal&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Patients unable to understand the study procedure.&#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>Tan Fırat Eyüboglu Assoc. Prof.</last_name>
      <phone>+90 530 463 60 59</phone>
      <email>tfeyuboglu@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics</name>
        <address>
          <city>Istanbul</city>
          <state>Unkapanı, Fatih</state>
          <zip>34083</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Root Canal Treatment</keyword>
    <keyword>Endodontic Treatment</keyword>
    <keyword>Root Canal Debridement</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Periapical 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/NCT06005545
  org study id: EC_5301_V1.0_CIP
  nct id: NCT06005545
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to compare the effectiveness of various root canal
        cleaning devices based on the principle of cavitation, ultrasonics, and conventional methods
        in a normal healthy adult population aged between 18 to 75 years requiring root canal
        treatment.
  
        The main question[s] it aims to answer are:
  
          -  Effectiveness of the cleaning mechanism
  
          -  Evaluate the safety of use of the device. Participants will be provided root canal
             treatment. Participants will be asked to record their post-operative pain levels in a
             Patient Pain diary. The healing rate of the lesion will be examined at follow-up visits
             using intraoral X-rays. At the end of the study, a statistical analysis of the clinical
             outcomes of the root canal treatment will be examined and evaluated in every group.
  Study title: "A Comparative Evaluation of Effectiveness in Root Canal Debridement using
        Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A
        Randomized Controlled Clinical Trial".
  
        Study Design: This is a prospective, 3-arm randomized, non-blinded, single-center pivotal
        clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean
        device with 2 comparator arms.
  
        Primary objective: To test the effectiveness of the Endoclean device for root canal
        debridement up to 12-month follow-up.
  
        Secondary objective: To test the extended effectiveness and safety of the Endoclean device up
        to a 24-month follow-up.
  
        Inclusion/Exclusion Criteria:
  
          1. Inclusion Criteria
  
             •Patients aged between 18-75 years with ASA (American Society of Anesthesiologists)
             classification 1 and 2.
  
             ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body mass index) under 30,
             a non-smoking patient with good exercise tolerance.
  
             ASA 2: A patient with mild systemic disease. Example: Patient with no functional
             limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI
             under 35, frequent social drinker, or cigarette smoker).
  
               -  Patients who agreed to participate and who have signed the informed consent.
  
               -  Patients presenting with symptomatic and/or asymptomatic apical periodontitis and
                  radiographic evidence of apical periodontitis in anterior or posterior teeth larger
                  than 1.5 mm in diameter.
  
               -  Mature tooth with closed apices
  
               -  Tooth that has never been treated with root canal therapy.
  
          2. Exclusion Criteria:
  
               -  Patients, who have pre-existing health or oral conditions that placed them at risk
                  during the trial.
  
               -  Patients with generalized untreated periodontal disease.
  
               -  Patients with a history of analgesic intake within the past 3 days or antibiotics
                  in the last 1 month.
  
               -  Uncooperative patients
  
               -  Teeth with immature apices, root resorption, or requiring extensive prosthetic
                  rehabilitation.
  
               -  Teeth that cannot be made functional nor restored or difficult to access teeth with
                  no importance (wisdom teeth)
  
               -  Teeth with insufficient periodontal support
  
               -  Teeth with poor prognosis, for example due to deep root caries, large root
                  resorption or open apex cases
  
               -  Fractured teeth
  
               -  Local anatomical factors such as an inaccessible root end
  
               -  Presence of fractured instrument in the root canal
  
               -  Pregnant women
  
               -  Patients unable to understand the study procedure.
  
        Number of Participants:
  
        Total number of participants = 109 subjects Arm 1: 40 subjects Arm 2: 40 subjects Arm 3: 29
        subjects Test device: Endoclean (Lumendo AG): hydraulic cavitation cleaning device Control
        device 1: Passive ultrasonic irrigation (PUI) Control device 2: Rotary files with standard
        NaOCl irrigation Study duration: 2-3 years The results of the Endoclean group shall be
        compared to data gathered from the comparator device groups and results shall be presented in
        the clinical investigation report.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a prospective, 3- arm randomized, non-blinded, single center pivotal clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean device with 2 comparator arms.
  Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06, Arm 2: Endoclean (EC) group; shaping up to WL with 20.06; EC application tip kept 3mm short of WL, irrigation protocol with NaOCl (sodium hypochlorite) Arm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary effectiveness endpoint
  time frame: 12 months
  description: Successful healing of periapical lesion up to 12 months post-procedure where success is defined as completely healed or healing lesion with absence of clinical symptoms.
  Healing is assessed by measuring the reduction in periapical lesion radiolucency, up to 12 months post-procedure, using the PAI (periapical index score).
  The absence of clinical symptoms is defined as:
  The patient had no discomfort in treated tooth
  The patient had no percussive pain during the examination in treated tooth
  measure: Safety endpoint
  time frame: 1 month
  description: Freedom from postoperative pain up to 7 days of follow-up period (24 hours, 48 hours, 72 hours, 7 days and 1 month). Pain is measured by Visual Analogue Scale (VAS) assessment.The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. The VAS is used to assist individuals to determine pain levels, who may not be accustomed to rating their pain on other types of scales, such as a numeric rating scale.
  measure: Secondary effectiveness endpoints
  time frame: 24 months
  description: Successful healing of periapical lesion up to 24 months post-procedure. Long-term effectiveness success shall be defined as a continued reduction or complete absence of periapical lesion radiolucency at 24m FU since the procedure with no clinical symptoms (i.e no discomfort in treated tooth and no percussive pain during examination)
  arm group label: Passive Ultrasonic Irrigation group (PUI)
  arm group type: Active Comparator
  description: Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06,
  arm group label: Endoclean group (EC)
  arm group type: Experimental
  description: Arm 2: Endoclean (EC) group; shaping up to WL with 20.06; EC application tip kept 3mm short of WL, irrigation protocol with NaOCl (sodium hypochlorite)
  arm group label: Conventional Group
  arm group type: Active Comparator
  description: Arm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite)
  intervention type: Device
  intervention name: Passive Ultrasonic Irrigation (PUI) group
  description: Passive ultrasonic irrigation is the current golden standard in root canal cleaning and irrigation devices. It is used after root canal shaping using manual or rotary instruments. It uses sodium hypochlorite which is mobilized in the canal using ultrasonic non-cutting tips to clean, debride, disinfect, and prepare the root canal for obturation.
  arm group label: Passive Ultrasonic Irrigation group (PUI)
  other name: Ultrasonic group
  intervention type: Device
  intervention name: Endoclean (EC) group
  description: Endoclean is a novel device that uses hydraulic inertial cavitation with the help of pressure and saline solution to debride the root canal after minimal shaping using manual or rotary shaping instruments. It is used to effectively clean, debride and prepare the root canal before obturation in the root canal treatment procedure.
  arm group label: Endoclean group (EC)
  other name: Cavitation group
  intervention type: Device
  intervention name: Conventional group
  description: Conventional root canal preparation uses manual or rotary files along with manual irrigation using syringes and irrigant solutions like sodium hypochlorite or EDTA to clean, debride and prepare the root canal for obturation.
  arm group label: Conventional Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tan Fırat Eyüboglu Assoc. Prof.
  phone: +90 530 463 60 59
  email: tfeyuboglu@yahoo.com
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Periapical Periodontitis
  sharing ipd: No