<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/NCT03750162</url>
  </required_header>
  <id_info>
    <org_study_id>2016-27194235-02</org_study_id>
    <nct_id>NCT03750162</nct_id>
  </id_info>
  <brief_title>Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques</brief_title>
  <official_title>Enterococcus Faecalis Elimination in Retreatment Cases Using Passive Ultrasonic Irrigation (PUI), Manual Dynamic Activation (MDA) and Photodynamic Therapy (PDT): a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bulent Ecevit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bulent Ecevit University</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>
      Nonsurgical root canal retreatment may become essential when the initial endodontic treatment&#xD;
      fails because of the persistent intracanal or extracanal infections.It has been stated that&#xD;
      the one of the main cause of posttreatment disease is the persistent or reintroduced&#xD;
      microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as&#xD;
      irrigation agitation methods can help elimination of bacteria from root canal systems.&#xD;
&#xD;
      The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation,&#xD;
      manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic&#xD;
      retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a&#xD;
      single visit root canal treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-six teeth with a single root and a single canal with posttreatment apical&#xD;
      periodontitis which needed retreatment were selected for this study. Teeth were randomly&#xD;
      divided into 3 groups according to the supplementary disinfection techniques used: Passive&#xD;
      ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological&#xD;
      samples were taken before any intervention, after conventional chemo-mechanical preparation,&#xD;
      and after disinfection techniques with sterile paper points and held in thioglycollate broth,&#xD;
      and then were transferred to the microbiological laboratory. The amounts of e.faecalis in&#xD;
      these samples was measured by using PCR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">September 5, 2017</completion_date>
  <primary_completion_date type="Actual">June 15, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacteria change</measure>
    <time_frame>1 year</time_frame>
    <description>Bacteria samples were taken at 3 step; before any intervention, after chemomechanical preparation, and after applying supplementary disinfection techniques</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Root Canal Infection</condition>
  <condition>Periapical; Infection</condition>
  <arm_group>
    <arm_group_label>Passive Ultrasonic irrigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irrigation solution was ultrasonically activated in the canal for 1 minute by using IrriSafe tip coupled to an ultrasonic device with VDW Ultra .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manuel dynamic activation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irrigation solution was activated with a well-fitting a ProtaperNext X3 gutta-percha point placed to working length was then moved in push - pull motions at a rate of 100 strokes/per minute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Photodynamic Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal was filled by 0.5 mL of 0.01% methylene blue (MB) solution for 5 minutes, then radiated by the light supply of a diode laser AMD picasso with a wavelength of 810 nm for 40 seconds (0.2 W).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VDW Ultra</intervention_name>
    <description>supplementary disinfection technique</description>
    <arm_group_label>Passive Ultrasonic irrigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AMD picasso</intervention_name>
    <description>supplementary disinfection technique</description>
    <arm_group_label>Photodynamic Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProtaperNext X3 gutta-percha</intervention_name>
    <description>supplementary disinfection technique</description>
    <arm_group_label>Manuel dynamic activation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Teeth with fractured instrument, resorption, perforation, ledge, over fillings Periodontal&#xD;
        pockets deeper than 4 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevinç Aktemur Türker</last_name>
    <role>Study Director</role>
    <affiliation>Bulent Ecevit University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bulent Ecevit University Faculty of Dentistry Department of Endodontics</name>
      <address>
        <city>Zonguldak</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Asnaashari M, Godiny M, Azari-Marhabi S, Tabatabaei FS, Barati M. Comparison of the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of Root Canal in Endodontic Retreatment in Patients With Periradicular Lesions. J Lasers Med Sci. 2016 Spring;7(2):99-104. doi: 10.15171/jlms.2016.17. Epub 2016 Mar 27.</citation>
    <PMID>27330705</PMID>
  </reference>
  <reference>
    <citation>Rodrigues RC, Antunes HS, Neves MA, Siqueira JF Jr, Rocas IN. Infection Control in Retreatment Cases: In Vivo Antibacterial Effects of 2 Instrumentation Systems. J Endod. 2015 Oct;41(10):1600-5. doi: 10.1016/j.joen.2015.06.005. Epub 2015 Jul 30.</citation>
    <PMID>26234543</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bulent Ecevit University</investigator_affiliation>
    <investigator_full_name>Sevinç Aktemur Türker</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>photodynamic therapy</keyword>
  <keyword>diode laser</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03750162
org study id: 2016-27194235-02
nct id: NCT03750162
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nonsurgical root canal retreatment may become essential when the initial endodontic treatment
      fails because of the persistent intracanal or extracanal infections.It has been stated that
      the one of the main cause of posttreatment disease is the persistent or reintroduced
      microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as
      irrigation agitation methods can help elimination of bacteria from root canal systems.

      The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation,
      manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic
      retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a
      single visit root canal treatment.
Thirty-six teeth with a single root and a single canal with posttreatment apical
      periodontitis which needed retreatment were selected for this study. Teeth were randomly
      divided into 3 groups according to the supplementary disinfection techniques used: Passive
      ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological
      samples were taken before any intervention, after conventional chemo-mechanical preparation,
      and after disinfection techniques with sterile paper points and held in thioglycollate broth,
      and then were transferred to the microbiological laboratory. The amounts of e.faecalis in
      these samples was measured by using PCR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Bacteria change
time frame: 1 year
description: Bacteria samples were taken at 3 step; before any intervention, after chemomechanical preparation, and after applying supplementary disinfection techniques
arm group label: Passive Ultrasonic irrigation
arm group type: Experimental
description: Irrigation solution was ultrasonically activated in the canal for 1 minute by using IrriSafe tip coupled to an ultrasonic device with VDW Ultra .
arm group label: Manuel dynamic activation
arm group type: Experimental
description: Irrigation solution was activated with a well-fitting a ProtaperNext X3 gutta-percha point placed to working length was then moved in push - pull motions at a rate of 100 strokes/per minute
arm group label: Photodynamic Therapy
arm group type: Experimental
description: Root canal was filled by 0.5 mL of 0.01% methylene blue (MB) solution for 5 minutes, then radiated by the light supply of a diode laser AMD picasso with a wavelength of 810 nm for 40 seconds (0.2 W).
intervention type: Device
intervention name: VDW Ultra
description: supplementary disinfection technique
arm group label: Passive Ultrasonic irrigation
intervention type: Device
intervention name: AMD picasso
description: supplementary disinfection technique
arm group label: Photodynamic Therapy
intervention type: Device
intervention name: ProtaperNext X3 gutta-percha
description: supplementary disinfection technique
arm group label: Manuel dynamic activation
criteria: 
gender: All
minimum age: 14 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sevinç Aktemur Türker
role: Study Director
affiliation: Bulent Ecevit University
facility: 
country: Turkey
citation: Asnaashari M, Godiny M, Azari-Marhabi S, Tabatabaei FS, Barati M. Comparison of the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of Root Canal in Endodontic Retreatment in Patients With Periradicular Lesions. J Lasers Med Sci. 2016 Spring;7(2):99-104. doi: 10.15171/jlms.2016.17. Epub 2016 Mar 27.
PMID: 27330705
citation: Rodrigues RC, Antunes HS, Neves MA, Siqueira JF Jr, Rocas IN. Infection Control in Retreatment Cases: In Vivo Antibacterial Effects of 2 Instrumentation Systems. J Endod. 2015 Oct;41(10):1600-5. doi: 10.1016/j.joen.2015.06.005. Epub 2015 Jul 30.
PMID: 26234543
responsible party type: Principal Investigator
investigator affiliation: Bulent Ecevit University
investigator full name: Sevinç Aktemur Türker
investigator title: Associate Professor
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: No