<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/NCT03783520</url>
  </required_header>
  <id_info>
    <org_study_id>Cukurova Endodontics</org_study_id>
    <nct_id>NCT03783520</nct_id>
  </id_info>
  <brief_title>Postoperative Pain After Using Er,Cr,YSGG Lazer Irradiation During Root Canal Treatment</brief_title>
  <official_title>Postoperative Pain After Using Er,Cr: YSGG Laser Irradiation Versus NaOCl Irrigation: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova 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>
      Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective&#xD;
      root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali&#xD;
      irrigant with pH 11.0 -12.0. Nearby its high antimicrobial efficacy, cytotoxic features make&#xD;
      it questionable when it comes contact with periradicular tissues. Several irrigation&#xD;
      materials were investigated less cytotoxic, more or equal antimicrobial to avoid such adverse&#xD;
      effects. Calcium hypochlorite, chlorhexidine, chitosan and antibiotics are some of the&#xD;
      chemicals tested. Laser is not a chemical but its action may show antibacterial effect.&#xD;
      Studies showed that Er,Cr:YSGG laser is strongly antibacterial against Enterococcus faecalis&#xD;
      biofilm. This antibacterial effect were frequently obtained with laser activated irrigation&#xD;
      (LAI) or photon-induced photoacoustic streaming (PIPS) in the literature. The aim of this&#xD;
      study was to evaluate whether disinfection procedure with laser provides more or less benefit&#xD;
      in terms of postoperative pain when compared with the conventional NaOCl irrigation method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both for maxillary and mandibular teeth, infiltration anesthesia were achieved by local&#xD;
      anesthetic with 2 ml articaine hydrochloride with 1:200000 epinephrine (Maxicaine, VEM İlaç,&#xD;
      Ist, Turkey). Endodontic access preparations were performed using diamond round burs. After&#xD;
      the canals became visible, patency was checked with a K hand file (VDW, Munich, Germany), and&#xD;
      a rubber dam was placed for isolation. The working length (WL) was determined with an&#xD;
      electronic apex locator (Raypex 6, VDW) and accepted when three green bars were reached.&#xD;
&#xD;
      A crown-down preparation technique was performed using Reciproc nickel-titanium instruments&#xD;
      (VDW, Munich, Germany) R#50 according to the manufacturers' instruction until the WL. During&#xD;
      the instrumentation procedures, the root canals were irrigated with 6 ml of 2,5% NaOCl&#xD;
      between each file.&#xD;
&#xD;
      In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™,&#xD;
      Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following&#xD;
      parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to&#xD;
      10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase,&#xD;
      Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of&#xD;
      the WL. Irradiation was delivered along the entire length of the root canal with helicoradial&#xD;
      movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20&#xD;
      seconds between each irradiation.&#xD;
&#xD;
      In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final&#xD;
      irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm&#xD;
      short of the WL.&#xD;
&#xD;
      At the end of disinfection procedures, each root canal was dried with paper points and the&#xD;
      largest gutta-percha cone that reached the WL without any resistance was used as the master&#xD;
      cone. Measurements from the electronic apex locator were confirmed radiographically. In cases&#xD;
      of discrepancies between the radiographic and electronic measurements, the latter was&#xD;
      selected. All root canals were filled with gutta-percha and root canal sealer (Adseal Meta&#xD;
      Biomed Co, Korea) using the lateral condensation technique. The teeth were coronally sealed&#xD;
      with composite resin (Premise, Kerr, Salerno, Italy). After the completion of the root&#xD;
      fillings, postoperative instructions were given to all patients and prescribed 200 mg&#xD;
      ibuprofen only one tablet if it is needed within the 0- to 6-hour time interval after the&#xD;
      treatment and then one for every 8 hours in the event of pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Postoperative pain</measure>
    <time_frame>0-24 hours after root canal treatment</time_frame>
    <description>Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, &quot;0&quot; and &quot;1&quot; scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed &quot;3&quot;. Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Er,Cr:YSGG Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium hypochlorite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Er,Cr:YSGG Laser</intervention_name>
    <description>Er,Cr:YSGG Laser is used for disinfection of the root canals.</description>
    <arm_group_label>Er,Cr:YSGG Laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sodium hypochlorite</intervention_name>
    <description>Sodium hypochlorite is used for disinfection of the root canals</description>
    <arm_group_label>Sodium hypochlorite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1)Single-rooted, maxillary and mandibular incisors, canines or premolars that were&#xD;
        asymptomatic (no preoperative pain, swelling or acute endodontic or periodontal abscess).&#xD;
        2)Nonvital pulps and did not respond to cold testing.&#xD;
&#xD;
        3)People had no systemic diseases or allergies to local anesthetic agents . 4)People had&#xD;
        not received any endodontic treatment previously. 5)People had no radiographic evidence of&#xD;
        periapical bone loss.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant and breastfeeding women&#xD;
&#xD;
          2. Patients taking analgesic, anti-inflammatory, or antibiotic medications during seven&#xD;
             days prior to beginning of treatment.&#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>
  <reference>
    <citation>Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.</citation>
    <PMID>23402273</PMID>
  </reference>
  <reference>
    <citation>Dewsnup N, Pileggi R, Haddix J, Nair U, Walker C, Varella CH. Comparison of bacterial reduction in straight and curved canals using erbium, chromium:yttrium-scandium-gallium-garnet laser treatment versus a traditional irrigation technique with sodium hypochlorite. J Endod. 2010 Apr;36(4):725-8. doi: 10.1016/j.joen.2009.11.017. Epub 2010 Feb 6.</citation>
    <PMID>20307752</PMID>
  </reference>
  <reference>
    <citation>Figini L, Lodi G, Gorni F, Gagliani M. Single versus multiple visits for endodontic treatment of permanent teeth: a Cochrane systematic review. J Endod. 2008 Sep;34(9):1041-7. doi: 10.1016/j.joen.2008.06.009.</citation>
    <PMID>18718362</PMID>
  </reference>
  <reference>
    <citation>Christo JE, Zilm PS, Sullivan T, Cathro PR. Efficacy of low concentrations of sodium hypochlorite and low-powered Er,Cr:YSGG laser activated irrigation against an Enterococcus faecalis biofilm. Int Endod J. 2016 Mar;49(3):279-86. doi: 10.1111/iej.12447. Epub 2015 Apr 1.</citation>
    <PMID>25772335</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Görkem Özbilen</investigator_full_name>
    <investigator_title>Specialist Dentist</investigator_title>
  </responsible_party>
  <keyword>root canal treatment</keyword>
  <keyword>intracanal irrigation</keyword>
  <keyword>Laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Hypochlorite</mesh_term>
    <mesh_term>Eusol</mesh_term>
  </intervention_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/NCT03783520
org study id: Cukurova Endodontics
nct id: NCT03783520
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective
      root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali
      irrigant with pH 11.0 -12.0. Nearby its high antimicrobial efficacy, cytotoxic features make
      it questionable when it comes contact with periradicular tissues. Several irrigation
      materials were investigated less cytotoxic, more or equal antimicrobial to avoid such adverse
      effects. Calcium hypochlorite, chlorhexidine, chitosan and antibiotics are some of the
      chemicals tested. Laser is not a chemical but its action may show antibacterial effect.
      Studies showed that Er,Cr:YSGG laser is strongly antibacterial against Enterococcus faecalis
      biofilm. This antibacterial effect were frequently obtained with laser activated irrigation
      (LAI) or photon-induced photoacoustic streaming (PIPS) in the literature. The aim of this
      study was to evaluate whether disinfection procedure with laser provides more or less benefit
      in terms of postoperative pain when compared with the conventional NaOCl irrigation method.
Both for maxillary and mandibular teeth, infiltration anesthesia were achieved by local
      anesthetic with 2 ml articaine hydrochloride with 1:200000 epinephrine (Maxicaine, VEM İlaç,
      Ist, Turkey). Endodontic access preparations were performed using diamond round burs. After
      the canals became visible, patency was checked with a K hand file (VDW, Munich, Germany), and
      a rubber dam was placed for isolation. The working length (WL) was determined with an
      electronic apex locator (Raypex 6, VDW) and accepted when three green bars were reached.

      A crown-down preparation technique was performed using Reciproc nickel-titanium instruments
      (VDW, Munich, Germany) R#50 according to the manufacturers' instruction until the WL. During
      the instrumentation procedures, the root canals were irrigated with 6 ml of 2,5% NaOCl
      between each file.

      In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™,
      Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following
      parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to
      10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase,
      Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of
      the WL. Irradiation was delivered along the entire length of the root canal with helicoradial
      movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20
      seconds between each irradiation.

      In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final
      irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm
      short of the WL.

      At the end of disinfection procedures, each root canal was dried with paper points and the
      largest gutta-percha cone that reached the WL without any resistance was used as the master
      cone. Measurements from the electronic apex locator were confirmed radiographically. In cases
      of discrepancies between the radiographic and electronic measurements, the latter was
      selected. All root canals were filled with gutta-percha and root canal sealer (Adseal Meta
      Biomed Co, Korea) using the lateral condensation technique. The teeth were coronally sealed
      with composite resin (Premise, Kerr, Salerno, Italy). After the completion of the root
      fillings, postoperative instructions were given to all patients and prescribed 200 mg
      ibuprofen only one tablet if it is needed within the 0- to 6-hour time interval after the
      treatment and then one for every 8 hours in the event of pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Evaluation of Postoperative pain
time frame: 0-24 hours after root canal treatment
description: Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed "3". Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.
arm group label: Er,Cr:YSGG Laser
arm group type: Experimental
description: In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.
arm group label: Sodium hypochlorite
arm group type: Active Comparator
description: In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.
intervention type: Device
intervention name: Er,Cr:YSGG Laser
description: Er,Cr:YSGG Laser is used for disinfection of the root canals.
arm group label: Er,Cr:YSGG Laser
intervention type: Other
intervention name: Sodium hypochlorite
description: Sodium hypochlorite is used for disinfection of the root canals
arm group label: Sodium hypochlorite
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.
PMID: 23402273
citation: Dewsnup N, Pileggi R, Haddix J, Nair U, Walker C, Varella CH. Comparison of bacterial reduction in straight and curved canals using erbium, chromium:yttrium-scandium-gallium-garnet laser treatment versus a traditional irrigation technique with sodium hypochlorite. J Endod. 2010 Apr;36(4):725-8. doi: 10.1016/j.joen.2009.11.017. Epub 2010 Feb 6.
PMID: 20307752
citation: Figini L, Lodi G, Gorni F, Gagliani M. Single versus multiple visits for endodontic treatment of permanent teeth: a Cochrane systematic review. J Endod. 2008 Sep;34(9):1041-7. doi: 10.1016/j.joen.2008.06.009.
PMID: 18718362
citation: Christo JE, Zilm PS, Sullivan T, Cathro PR. Efficacy of low concentrations of sodium hypochlorite and low-powered Er,Cr:YSGG laser activated irrigation against an Enterococcus faecalis biofilm. Int Endod J. 2016 Mar;49(3):279-86. doi: 10.1111/iej.12447. Epub 2015 Apr 1.
PMID: 25772335
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Görkem Özbilen
investigator title: Specialist Dentist
mesh term: Pain, Postoperative
mesh term: Sodium Hypochlorite
mesh term: Eusol
sharing ipd: No