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/NCT06031792</url>
    </required_header>
    <id_info>
      <org_study_id>KingAbdullahUH1</org_study_id>
      <nct_id>NCT06031792</nct_id>
    </id_info>
    <brief_title>Radiographic Assessment of the Healing Pattern Associated Withperiradicular Endodontic Microsurgery</brief_title>
    <official_title>A 2D and 3D Radiographic Assessment of the Healing Pattern Associated With Conventional and Piezoelectric Periradicular Endodontic Microsurgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Abdullah University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jordan University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King Abdullah 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>
        Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in&#xD;
        cases in which healing has not occurred after non-surgical treatment or if it is not&#xD;
        feasible. Recent advances in techniques and materials have resulted in more predictable&#xD;
        outcomes. Piezotome is a new and innovative device, but limited evidence is available&#xD;
        regarding its use in endodontics. The aim of this study is to assess the healing pattern of&#xD;
        conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2-&#xD;
        Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the&#xD;
        presence, location, and arrangement of bacteria in the excised apical portion of the root&#xD;
        canal system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After meeting the inclusion criteria, a total of 44 Patients in need of endodontic&#xD;
        microsurgery with persistent symptoms after acceptable primary root canal treatment or failed&#xD;
        retreatment with persistent symptoms/periapical lesions will be included in this study.&#xD;
        Participants will be randomly allocated to group one; conventional periradicular surgery or&#xD;
        group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and&#xD;
        limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient.&#xD;
        At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT&#xD;
        will be taken. All images will be evaluated on high-definition LCD display with installed&#xD;
        ImageJ software and CBCT software, and window settings will be fixed for all cases.&#xD;
        Radiographs will be evaluated by two calibrated dentists. The excised root tip with their&#xD;
        surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by&#xD;
        immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic&#xD;
        laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial&#xD;
        sectioning with hematoxylin and eosin staining will be done to locate the areas with the most&#xD;
        severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be&#xD;
        used to detect the presence of bacteria.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 30, 2021</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>A randomized prospective clinical study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic Healing</measure>
      <time_frame>to measure periapical lesion after 1 year</time_frame>
      <description>To compare conventional and piezotome endodontic apical surgery in terms of healing using 2-Dimensional and 3-Dimensional imaging CBCT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Histological outcome</measure>
      <time_frame>one sample is taken and compared immediately after surgery</time_frame>
      <description>To correlate histological findings with clinical observation and radiographic findings for failed root canal treated teeth presenting</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Periapical; Infection</condition>
    <arm_group>
      <arm_group_label>Piezo endodontic surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental: Piezo endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional endodontic surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active Comparator: Conventional endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endodontic Microsurgery</intervention_name>
      <description>Osteotomy will be done with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex , the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth at ( 0 - 10) degree bevel , using either conventional dental hand-piece or piezotome (Piezotome Cube by ACTEON ).The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets. Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view.</description>
      <arm_group_label>Conventional endodontic surgery</arm_group_label>
      <arm_group_label>Piezo endodontic surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Medically fit patients&#xD;
  &#xD;
            -  Age (18-65 )&#xD;
  &#xD;
            -  Teeth that are periodontally healthy&#xD;
  &#xD;
            -  Coronally sealed root canal treated teeth&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with an active systematic disease that may affect the short- and long-term&#xD;
               outcomes or restrict surgical intervention&#xD;
  &#xD;
            -  Emotionally distressed patients&#xD;
  &#xD;
            -  Patients who had received analgesics or antibiotics prior to surgery will be postponed&#xD;
  &#xD;
            -  Cases where orthograde endodontic treatment is feasible ,will be retreated at the&#xD;
               post-graduate clinics and not included in this study&#xD;
  &#xD;
            -  Teeth with poor prognosis (e.g., non-restorable , vertical root fracture , short&#xD;
               roots, non-strategic tooth, endo-perio lesi&#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_contact>
      <last_name>Lama A Awawdeh, PhD</last_name>
      <phone>+962795412954</phone>
      <email>lawawdeh@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jordan University of Science and Technology</name>
        <address>
          <city>Irbid</city>
          <zip>POBOX 3030</zip>
          <country>Jordan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lama A Awawdeh, PhD</last_name>
        <phone>0795412954</phone>
        <email>lawawdeh@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jordan University of Science and Technology</name>
        <address>
          <city>Irbid</city>
          <zip>POBOX 3030</zip>
          <country>Jordan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lama A Awawdeh, PhD</last_name>
        <phone>+962795412954</phone>
        <email>lawawdeh@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06031792
  org study id: KingAbdullahUH1
  nct id: NCT06031792
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in
        cases in which healing has not occurred after non-surgical treatment or if it is not
        feasible. Recent advances in techniques and materials have resulted in more predictable
        outcomes. Piezotome is a new and innovative device, but limited evidence is available
        regarding its use in endodontics. The aim of this study is to assess the healing pattern of
        conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2-
        Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the
        presence, location, and arrangement of bacteria in the excised apical portion of the root
        canal system.
  After meeting the inclusion criteria, a total of 44 Patients in need of endodontic
        microsurgery with persistent symptoms after acceptable primary root canal treatment or failed
        retreatment with persistent symptoms/periapical lesions will be included in this study.
        Participants will be randomly allocated to group one; conventional periradicular surgery or
        group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and
        limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient.
        At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT
        will be taken. All images will be evaluated on high-definition LCD display with installed
        ImageJ software and CBCT software, and window settings will be fixed for all cases.
        Radiographs will be evaluated by two calibrated dentists. The excised root tip with their
        surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by
        immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic
        laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial
        sectioning with hematoxylin and eosin staining will be done to locate the areas with the most
        severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be
        used to detect the presence of bacteria.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomized prospective clinical study
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Radiographic Healing
  time frame: to measure periapical lesion after 1 year
  description: To compare conventional and piezotome endodontic apical surgery in terms of healing using 2-Dimensional and 3-Dimensional imaging CBCT.
  measure: Histological outcome
  time frame: one sample is taken and compared immediately after surgery
  description: To correlate histological findings with clinical observation and radiographic findings for failed root canal treated teeth presenting
  arm group label: Piezo endodontic surgery
  arm group type: Experimental
  description: Experimental: Piezo endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch
  arm group label: Conventional endodontic surgery
  arm group type: Experimental
  description: Active Comparator: Conventional endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation
  intervention type: Procedure
  intervention name: Endodontic Microsurgery
  description: Osteotomy will be done with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex , the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth at ( 0 - 10) degree bevel , using either conventional dental hand-piece or piezotome (Piezotome Cube by ACTEON ).The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets. Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view.
  arm group label: Conventional endodontic surgery
  arm group label: Piezo endodontic surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lama A Awawdeh, PhD
  phone: +962795412954
  email: lawawdeh@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Jordan
  responsible party type: Sponsor
  sharing ipd: No