<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/NCT04486196</url>
  </required_header>
  <id_info>
    <org_study_id>BİRUNİ-BAP-01-01</org_study_id>
    <nct_id>NCT04486196</nct_id>
  </id_info>
  <brief_title>Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis</brief_title>
  <official_title>Effect of Root Canal Disinfection With 980 µm Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biruni University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biruni 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode&#xD;
      laser following chemomechanical root canal preparation on the severity of pain after root&#xD;
      canal treatment (RCT).&#xD;
&#xD;
      Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical&#xD;
      index (PAI) score 3 or 4 were included. All patients were treated with two visits of root&#xD;
      canal treatment including dressing with calcium hydroxide. Patients were randomly divided&#xD;
      into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml&#xD;
      2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)':&#xD;
      Root canals were irradiated with 980 µm diode laser after final irrigation at both visits.&#xD;
      The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7&#xD;
      days. In addition, analgesic intake and time intervals were recorded by patients. The&#xD;
      collected data were statistically analyzed with the Chi-square and Mann-Whitney U test&#xD;
      (p&lt;0.05).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2019</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">November 2, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>7 days</time_frame>
    <description>Post-operative pain levels in each group will be assessed by visual analog scale (VAS).The pain levels will be evaluated after 8, 24, 48 hours and 7 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic intake</measure>
    <time_frame>7 days</time_frame>
    <description>After first and second appointments, analgesic use and time intervals will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Apical Periodontitis</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Control (No Laser) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser Disinfection (LD) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water, root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle. This cycle was applied 4 times for each root canal. The optical fiber (Medency) was inserted 1 mm short of the apex and the root canals were slowly (at a speed of 2mm/s) irradiated from apical to coronal in continuous circling movements to treat all dentinal tubules in one cycle for each power.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medency Primo Diode Laser Device (Medency, Vicenza, Italy)</intervention_name>
    <description>Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.</description>
    <arm_group_label>Laser Disinfection (LD) Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),</intervention_name>
    <description>Final conventional irrigation</description>
    <arm_group_label>Control (No Laser) Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy patients&#xD;
&#xD;
          -  Patients that had asymptomatic, single-rooted teeth with PAI score 3 or 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  antibiotic use with in the last month,&#xD;
&#xD;
          -  anti-inflammatory analgesic use within the last five days,&#xD;
&#xD;
          -  systemic disorder, pregnancy or lactation,&#xD;
&#xD;
          -  traumatic occlusion,&#xD;
&#xD;
          -  presence of other teeth requiring RCT,&#xD;
&#xD;
          -  teeth with root canal fillings,&#xD;
&#xD;
          -  calcified canals,&#xD;
&#xD;
          -  root resorption,&#xD;
&#xD;
          -  periodontal diseases,&#xD;
&#xD;
          -  sinus tracts&#xD;
&#xD;
          -  severe crown destruction preventing rubber-dam application&#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_official>
    <last_name>Sema Sönmez Kaplan, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biruni University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biruni University</name>
      <address>
        <city>İstanbul</city>
        <zip>34010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Biruni University</investigator_affiliation>
    <investigator_full_name>Sema Sönmez Kaplan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>diode laser</keyword>
  <keyword>irrigation</keyword>
  <keyword>post-operative pain</keyword>
  <keyword>root canal treatment</keyword>
  <keyword>visual analog scale</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>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not decided which collected IPD or which IPD that underlie results to share in a publication.</ipd_description>
  </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/NCT04486196
org study id: BİRUNİ-BAP-01-01
nct id: NCT04486196
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode
      laser following chemomechanical root canal preparation on the severity of pain after root
      canal treatment (RCT).

      Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical
      index (PAI) score 3 or 4 were included. All patients were treated with two visits of root
      canal treatment including dressing with calcium hydroxide. Patients were randomly divided
      into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml
      2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)':
      Root canals were irradiated with 980 µm diode laser after final irrigation at both visits.
      The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7
      days. In addition, analgesic intake and time intervals were recorded by patients. The
      collected data were statistically analyzed with the Chi-square and Mann-Whitney U test
      (p<0.05).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-operative pain
time frame: 7 days
description: Post-operative pain levels in each group will be assessed by visual analog scale (VAS).The pain levels will be evaluated after 8, 24, 48 hours and 7 days.
measure: Analgesic intake
time frame: 7 days
description: After first and second appointments, analgesic use and time intervals will be recorded.
arm group label: Control (No Laser) Group
arm group type: Experimental
description: The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water.
arm group label: Laser Disinfection (LD) Group
arm group type: Experimental
description: After final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water, root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle. This cycle was applied 4 times for each root canal. The optical fiber (Medency) was inserted 1 mm short of the apex and the root canals were slowly (at a speed of 2mm/s) irradiated from apical to coronal in continuous circling movements to treat all dentinal tubules in one cycle for each power.
intervention type: Device
intervention name: Medency Primo Diode Laser Device (Medency, Vicenza, Italy)
description: Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.
arm group label: Laser Disinfection (LD) Group
intervention type: Procedure
intervention name: 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
description: Final conventional irrigation
arm group label: Control (No Laser) Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sema Sönmez Kaplan, DDS, PhD
role: Principal Investigator
affiliation: Biruni University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Biruni University
investigator full name: Sema Sönmez Kaplan
investigator title: Assistant Professor
mesh term: Periodontitis
mesh term: Periapical Periodontitis
mesh term: Pain, Postoperative
sharing ipd: Undecided
ipd description: Not decided which collected IPD or which IPD that underlie results to share in a publication.