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/NCT06006663</url>
    </required_header>
    <id_info>
      <org_study_id>eliminations of E.faecalis</org_study_id>
      <nct_id>NCT06006663</nct_id>
    </id_info>
    <brief_title>Effect of Hebal and Synthetic Medicamentss on Enterococcus Feacalis</brief_title>
    <official_title>Antimicrobial Efficacy of Synthetic Versus Herbal Intracanal Medicaments Against Enterococcus Faecalis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified&#xD;
        triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as&#xD;
        intracanal medication, against E.Faecalis in secondary endodontic infection cases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        we evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple&#xD;
        antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as&#xD;
        intracanal medication, against E.Faecalis in secondary endodontic infection cases by taking&#xD;
        three samples from root canal , the first sample after removing gutta percha from root canal&#xD;
        system, the second sample after shaping with protaper universal files and cleaning with 2.5%&#xD;
        sodium hypochlorite , the third sample after 7 days from application of the medication .&#xD;
  &#xD;
        samples will be diluted into ten fold serial dilution and then the diluted samples will be&#xD;
        cultured on bile esculin agar as it is selective media for enterococcus feacalis.&#xD;
  &#xD;
        bacterial reduction will be determined and comparision will be made .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 26, 2023</start_date>
    <completion_date type="Anticipated">December 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 5, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments</measure>
      <time_frame>time necessary for incubation of each sample is 24 hour</time_frame>
      <description>sample 1 will be taken after gutta percha removal sample 2 will be taken after cleaning and shaping sample 3 will be taken after apllying the intracanal medicament for one week</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Effective Intracanal Medicaments Against Enterococcus Faecalis</condition>
    <arm_group>
      <arm_group_label>group 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ibuprofen as intracanal medicament</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>modified triple antibiotic paste as intracanal medicament</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 3</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>curcumin as intracanal medicament</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 4</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>olive leaves as intracanal medicament</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ibuprofen 400 mg.</intervention_name>
      <description>synthetic intracanal medicament</description>
      <arm_group_label>group 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>modified triple antibiotic paste</intervention_name>
      <description>synthetic intracanal medicament</description>
      <arm_group_label>group 2</arm_group_label>
      <other_name>clindamycin, ciprofloxacin and metronidazole</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>curcumin</intervention_name>
      <description>herbal intracanal medicament</description>
      <arm_group_label>group 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>olive leaves extract</intervention_name>
      <description>herbal intracanal medicament</description>
      <arm_group_label>group 4</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Single rooted teeth.&#xD;
  &#xD;
            -  Teeth have clinical signs and symptoms of endodontic failure as sensitivity to&#xD;
               percussion, pain, swelling or fistula.&#xD;
  &#xD;
            -  Teeth with radiographic features of endodontic failure as persistent periapical lesion&#xD;
               or widening of periodontal ligament.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Teeth with fractures of the crown or root.&#xD;
  &#xD;
                 -  Teeth with periodontal pocket deeper than 4mm.&#xD;
  &#xD;
                 -  Teeth have procedural error like ledge, broken instrument, or perforation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>alaa essam abo laimon, demonstrator at university</last_name>
      <phone>01005690958</phone>
      <email>alaalamona@yahoo.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Alaa Essam Ahmed Abo Laimon</investigator_full_name>
      <investigator_title>Demonstrator , Endodontic department,Faculty of dentistry,Tanta university</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Bacterial Agents</mesh_term>
      <mesh_term>Metronidazole</mesh_term>
      <mesh_term>Ciprofloxacin</mesh_term>
      <mesh_term>Clindamycin</mesh_term>
      <mesh_term>Ibuprofen</mesh_term>
      <mesh_term>Curcumin</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/NCT06006663
  org study id: eliminations of E.faecalis
  nct id: NCT06006663
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified
        triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as
        intracanal medication, against E.Faecalis in secondary endodontic infection cases.
  we evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple
        antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as
        intracanal medication, against E.Faecalis in secondary endodontic infection cases by taking
        three samples from root canal , the first sample after removing gutta percha from root canal
        system, the second sample after shaping with protaper universal files and cleaning with 2.5%
        sodium hypochlorite , the third sample after 7 days from application of the medication .
  
        samples will be diluted into ten fold serial dilution and then the diluted samples will be
        cultured on bile esculin agar as it is selective media for enterococcus feacalis.
  
        bacterial reduction will be determined and comparision will be made .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments
  time frame: time necessary for incubation of each sample is 24 hour
  description: sample 1 will be taken after gutta percha removal sample 2 will be taken after cleaning and shaping sample 3 will be taken after apllying the intracanal medicament for one week
  arm group label: group 1
  arm group type: Active Comparator
  description: ibuprofen as intracanal medicament
  arm group label: group 2
  arm group type: Active Comparator
  description: modified triple antibiotic paste as intracanal medicament
  arm group label: group 3
  arm group type: Active Comparator
  description: curcumin as intracanal medicament
  arm group label: group 4
  arm group type: Active Comparator
  description: olive leaves as intracanal medicament
  intervention type: Drug
  intervention name: Ibuprofen 400 mg.
  description: synthetic intracanal medicament
  arm group label: group 1
  intervention type: Drug
  intervention name: modified triple antibiotic paste
  description: synthetic intracanal medicament
  arm group label: group 2
  other name: clindamycin, ciprofloxacin and metronidazole
  intervention type: Dietary Supplement
  intervention name: curcumin
  description: herbal intracanal medicament
  arm group label: group 3
  intervention type: Dietary Supplement
  intervention name: olive leaves extract
  description: herbal intracanal medicament
  arm group label: group 4
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: alaa essam abo laimon, demonstrator at university
  phone: 01005690958
  email: alaalamona@yahoo.com
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Alaa Essam Ahmed Abo Laimon
  investigator title: Demonstrator , Endodontic department,Faculty of dentistry,Tanta university
  mesh term: Anti-Bacterial Agents
  mesh term: Metronidazole
  mesh term: Ciprofloxacin
  mesh term: Clindamycin
  mesh term: Ibuprofen
  mesh term: Curcumin