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/NCT05964686</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-Rec ID 041908</org_study_id>
      <nct_id>NCT05964686</nct_id>
    </id_info>
    <brief_title>The Efficacy of Laser in Root Canal Disinfection</brief_title>
    <official_title>The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Future University in Egypt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Future University in Egypt</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>
        The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and&#xD;
        Diode/EDTA on post operative pain and bacterial count in root canal treatment in an&#xD;
        evidence-based clinical trial. The null hypothesis being tested is that there is no&#xD;
        difference in post operative pain and total bacterial count reduction between conventional&#xD;
        irrigation and the two types of lasers used.&#xD;
  &#xD;
        Thirty patients are equally divided into 3 separate groups :&#xD;
  &#xD;
          -  Group A (Conventional): 2.5% NaOCL and 17% EDTA.&#xD;
  &#xD;
          -  Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination&#xD;
  &#xD;
          -  Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient&#xD;
             is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before&#xD;
             any endodontic treatment. Microbiological analysis will be done for both aerobic and&#xD;
             anaerobic bacteria using Colony forming units. All data will be collected, tabulated,&#xD;
             summarized, and statistically analyzed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of lasers in disinfection of the root canal has been recently implemented. Lasers&#xD;
        have bactericidal effect, and have deep penetration depth inside the root canal up to 1000&#xD;
        um. Thus, it can be used effectively for disinfection of the root canal system following&#xD;
        biomechanical instrumentation reaching areas which were considered before non-reachable.&#xD;
  &#xD;
        The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and&#xD;
        Diode/EDTA on post operative pain and bacterial count in root canal treatment in an&#xD;
        evidence-based clinical trial. The null hypothesis being tested is that there is no&#xD;
        difference in post operative pain and total bacterial count reduction between conventional&#xD;
        irrigation and the two types of lasers used.&#xD;
  &#xD;
        Thirty patients are equally divided into 3 separate groups :&#xD;
  &#xD;
          -  Group A (Conventional): 2.5% NaOCL and 17% EDTA.&#xD;
  &#xD;
          -  Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination&#xD;
  &#xD;
          -  Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient&#xD;
             will be given pain scale chart (NRS scale) to record his/her pain level before any&#xD;
             endodontic treatment. After disinfection, local anesthetic and tooth isolation and&#xD;
             access cavity preparation, the first microbial samples (S1) will be collected using 3&#xD;
             sterile paper points and immediately placed inside sterile tubes containing transport&#xD;
             medium of thioglycolate, cleaning and shaping with final disinfection protocol will be&#xD;
             performed according to the group in which the participant was allocated to. Followed by&#xD;
             S2 sample. obturation using warm vertical compaction technique. Patients are asked to&#xD;
             mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and&#xD;
             rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure&#xD;
             Microbiological analysis will be done for both aerobic and anaerobic bacteria using&#xD;
             Colony forming units. All data will be collected, tabulated, summarized, and&#xD;
             statistically analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">December 30, 2022</completion_date>
    <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
    <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative pain assessment</measure>
      <time_frame>post operative pain will be assessed by calculating median and mean values of pain scores recorded by the patients after 6, 12, 24, 48, 72 hours, and up to 7 days after the procedure</time_frame>
      <description>Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes &quot;No pain&quot; and &quot;the worst pain&quot;.&#xD;
  Pain level assigned to one of 4 categorical scores:&#xD;
  No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quantitative microbiological analysis</measure>
      <time_frame>baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit</time_frame>
      <description>aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).&#xD;
  anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Pulp and Periapical Tissue Disease</condition>
    <condition>Pulp Necroses</condition>
    <condition>Pulp; Granuloma</condition>
    <arm_group>
      <arm_group_label>Conventional group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual laser group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Combined group C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Conventional group (NaOCl/EDTA)</intervention_name>
      <description>conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA</description>
      <arm_group_label>Conventional group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Dual laser group (Er,Cr:YSGG/Diode):</intervention_name>
      <description>Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection</description>
      <arm_group_label>Dual laser group B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Combined group (EDTA/Diode):</intervention_name>
      <description>17% EDTA was used to remove smear layer followed by diode laser for disinfection</description>
      <arm_group_label>Combined group C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Patients who are medically free.&#xD;
  &#xD;
                 -  Patient's age between 18-35 years.&#xD;
  &#xD;
                 -  One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic&#xD;
                    apical periodontitis requiring root canal treatment.&#xD;
  &#xD;
                 -  Patients complaining of no pain and without fistulous tract.&#xD;
  &#xD;
                 -  Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al.&#xD;
                    (1986)108&#xD;
  &#xD;
                 -  Closed apex.&#xD;
  &#xD;
                 -  Acceptance to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients suffering from any systemic disease.&#xD;
  &#xD;
            -  Patients who had received antibiotics during the last month.&#xD;
  &#xD;
            -  Patients taking analgesics 12 hours before interventions.&#xD;
  &#xD;
            -  Patients with history of tobacco usage&#xD;
  &#xD;
            -  Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.&#xD;
  &#xD;
            -  Teeth with previous endodontic treatment.&#xD;
  &#xD;
            -  Non restorable teeth where rubber dam could not be applied.&#xD;
  &#xD;
            -  Teeth with periodontal pocket more than 3 mm.&#xD;
  &#xD;
            -  Teeth with greater than grade 1 mobility.&#xD;
  &#xD;
            -  Teeth with swelling/sinus tract.&#xD;
  &#xD;
            -  Technical difficulties in the course of root canal treatment for example:&#xD;
  &#xD;
                 -  A tooth with curved roots&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <state>Abbassia</state>
          <zip>11566</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Future University in Egypt</investigator_affiliation>
      <investigator_full_name>Sara Zakaria Fahim</investigator_full_name>
      <investigator_title>assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>LASER</keyword>
    <keyword>Endodontics</keyword>
    <keyword>canal disinfection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Pulp Necrosis</mesh_term>
      <mesh_term>Granuloma</mesh_term>
      <mesh_term>Necrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Edetic Acid</mesh_term>
      <mesh_term>Pentetic Acid</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05964686
  org study id: FDASU-Rec ID 041908
  nct id: NCT05964686
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and
        Diode/EDTA on post operative pain and bacterial count in root canal treatment in an
        evidence-based clinical trial. The null hypothesis being tested is that there is no
        difference in post operative pain and total bacterial count reduction between conventional
        irrigation and the two types of lasers used.
  
        Thirty patients are equally divided into 3 separate groups :
  
          -  Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  
          -  Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  
          -  Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient
             is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before
             any endodontic treatment. Microbiological analysis will be done for both aerobic and
             anaerobic bacteria using Colony forming units. All data will be collected, tabulated,
             summarized, and statistically analyzed.
  The use of lasers in disinfection of the root canal has been recently implemented. Lasers
        have bactericidal effect, and have deep penetration depth inside the root canal up to 1000
        um. Thus, it can be used effectively for disinfection of the root canal system following
        biomechanical instrumentation reaching areas which were considered before non-reachable.
  
        The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and
        Diode/EDTA on post operative pain and bacterial count in root canal treatment in an
        evidence-based clinical trial. The null hypothesis being tested is that there is no
        difference in post operative pain and total bacterial count reduction between conventional
        irrigation and the two types of lasers used.
  
        Thirty patients are equally divided into 3 separate groups :
  
          -  Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  
          -  Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  
          -  Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient
             will be given pain scale chart (NRS scale) to record his/her pain level before any
             endodontic treatment. After disinfection, local anesthetic and tooth isolation and
             access cavity preparation, the first microbial samples (S1) will be collected using 3
             sterile paper points and immediately placed inside sterile tubes containing transport
             medium of thioglycolate, cleaning and shaping with final disinfection protocol will be
             performed according to the group in which the participant was allocated to. Followed by
             S2 sample. obturation using warm vertical compaction technique. Patients are asked to
             mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and
             rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure
             Microbiological analysis will be done for both aerobic and anaerobic bacteria using
             Colony forming units. All data will be collected, tabulated, summarized, and
             statistically analyzed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Postoperative pain assessment
  time frame: post operative pain will be assessed by calculating median and mean values of pain scores recorded by the patients after 6, 12, 24, 48, 72 hours, and up to 7 days after the procedure
  description: Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
  Pain level assigned to one of 4 categorical scores:
  No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
  measure: Quantitative microbiological analysis
  time frame: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit
  description: aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
  anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
  arm group label: Conventional group A
  arm group type: Active Comparator
  arm group label: Dual laser group B
  arm group type: Experimental
  arm group label: Combined group C
  arm group type: Experimental
  intervention type: Combination Product
  intervention name: Conventional group (NaOCl/EDTA)
  description: conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
  arm group label: Conventional group A
  intervention type: Combination Product
  intervention name: Dual laser group (Er,Cr:YSGG/Diode):
  description: Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
  arm group label: Dual laser group B
  intervention type: Combination Product
  intervention name: Combined group (EDTA/Diode):
  description: 17% EDTA was used to remove smear layer followed by diode laser for disinfection
  arm group label: Combined group C
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Future University in Egypt
  investigator full name: Sara Zakaria Fahim
  investigator title: assistant lecturer
  mesh term: Dental Pulp Necrosis
  mesh term: Granuloma
  mesh term: Necrosis
  mesh term: Edetic Acid
  mesh term: Pentetic Acid