<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/NCT03748498</url>
  </required_header>
  <id_info>
    <org_study_id>ag134134</org_study_id>
    <nct_id>NCT03748498</nct_id>
  </id_info>
  <brief_title>Effect of Low Level Laser Therapy on Post-endodontic Pain</brief_title>
  <official_title>Effect of Low Level Laser Therapy on Postoperative Pain After Single Visit Endodontic Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</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>
      This study was designed as a randomized, placebo-controlled trial of 2 groups. The treatment&#xD;
      procedures were performed by one operator. After local anesthesia and rubber dam isolation,&#xD;
      access cavity preparation was performed by diamond burs with high-speed hand pieces under the&#xD;
      water cooling. . Instrumentation of procedures was performed by Reciproc R50 files.&#xD;
      Irrigation protocol was completed, canal were dried, filled with gutta-percha cones and AH&#xD;
      Plus sealer. After chemo- mechanical instrumentation and root canal filling procedures, LLLT&#xD;
      was applied for 60 second per tooth using Nd-YAG laser ( λ=1064 nm,100 mJ, 10 Hz, 1-W) The&#xD;
      same procedures as in the laser group were performed, been completed but the laser was not&#xD;
      activated in this group. These patients were assigned as placebo group. Postoperative pain&#xD;
      was measured and documented via the Visual Analogue Scale. Chi-square test was performed in&#xD;
      analysis of the nominal data.There was statistically significant difference between groups at&#xD;
      the 12th and 24th hours (p&lt;.05). ). However, no statistically significant difference was&#xD;
      found between the groups at the 4th, 8th, 48th, and 72th hours (p&gt;.05). No statistically&#xD;
      significant differences were detected between the groups in terms of demographic data (age&#xD;
      and tooth number) except for gender (P &gt; .05).LLLT can decrease postoperative pain after root&#xD;
      canal treatment of single rooted teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was approved by the local ethics committee ....................., and informed&#xD;
      consent was received from all participants. Study subjects were selected among patients who&#xD;
      presented to the Department of Endodontics, Faculty of Dentistry ........................from&#xD;
      September 2017 to March 2018.&#xD;
&#xD;
      Root canal treatment was planned for patients who participated in this study and have single&#xD;
      root and single canal. Patients aged between 15 to 45 years. Exclusion criteria related with&#xD;
      teeth were swelling or sinus tract, acute pain, periodontal probing greater than 3mm,&#xD;
      internal and external resorption, fractured and cracked tooth, percussion sensitivity, and&#xD;
      periapical index classification 3, 4, 5 according to Orstavik et al. (1986). Exclusion&#xD;
      criteria related with systemic health of patients included diabetes, hypertension and&#xD;
      cardiovascular pathologies, the use of analgesics and / or antibiotics at least one week&#xD;
      before treatment, and using antidepressant drugs.The treatment procedures were performed by&#xD;
      one operator (G.A.). Initially, patients' age, gender, and tooth number were recorded by the&#xD;
      operator. 1.5 mL 2% articaine with 0.012 mg epinephrine (Ultracaine DS Forte; Aventis,&#xD;
      Istanbul, Turkey) was used as local anesthetic. After rubber dam isolation, access cavity&#xD;
      preparation was performed by diamond burs (ADIA Dental Burs, Turkey) with high-speed hand&#xD;
      pieces under the water cooling. A #10 K- type (Kerr Corporation, Orange, CA) file was&#xD;
      inserted to root canal to determine working length using an apex locator (Raypex, VDW).&#xD;
      Working length was set as 1 mm shorter than the apical foramen and confirmed with periapical&#xD;
      radiographs. Instrumentation of procedures was performed by Reciproc R50 files (VDW, Munich,&#xD;
      Germany). Irrigation protocol was completed 5 mL 17% EDTA (Werax, Turkey) and 15 mL 2.5%&#xD;
      sodium hypochlorite (NaOCl)(Wizard, Turkey ) with a side-vented needle (NaviTip needle;&#xD;
      Ultradent Products Inc, South Jordan, UT). Subsequently, canal were dried with paper points&#xD;
      and filled with gutta-percha cones and AH Plus sealer (Dentsply Maillefer). Lateral cold&#xD;
      condensation technique was used for obturation. Finally, coronal access cavity was restored&#xD;
      with a temporary restorative material (Cavit G; 3M ESPE, St Paul, MN). Permanent restoration&#xD;
      was completed after the end of the experiment.A randomization was produced using through a&#xD;
      website (http://www.random.org), after the clinician (G.A.) was completed all treatment&#xD;
      procedures. All procedures were conducted by one clinician (C.E.B.), and assignment was&#xD;
      concealed from the clinician who performed the laser applications (U.B.). Data analysis and&#xD;
      interpretation were completed by the other researcher (C.F.) After chemo- mechanical&#xD;
      instrumentation and root canal filling procedures, LLLT was applied for 60 second per tooth&#xD;
      using Nd-YAG laser ( λ=1064 nm,100 mJ, 10 Hz, 1-W[Deka smart file, DEKA, Italy]). Application&#xD;
      of the laser was performed through root canal and to the buccal mucosa over the apices of the&#xD;
      target tooth. An application biostimulation tip was used to ensure a constant distance of 10&#xD;
      mm to the tissue.The same procedures as in the laser group were performed, been completed but&#xD;
      the laser was not activated in this group. These patients were assigned as placebo&#xD;
      group.Postoperative pain was measured and documented via the Visual Analogue Scale (VAS). VAS&#xD;
      consists of a 100 mm line which is represented at one end by a sign 'No pain' and at the&#xD;
      other end 'unbearable pain'. This form was given to the each patient and they were instructed&#xD;
      to mark according to the pain intensity at 4th, 8th, 12th, 24th, 48th and 72th hours.There&#xD;
      was statistically significant difference between groups at the 12th and 24th hours (p&lt;.05).&#xD;
      However, no statistically significant difference was found between the groups at the 4th,&#xD;
      8th, 48th, and 72th hours (p&gt;.05). Aside from sex, No statistically significant differences&#xD;
      were detected between the groups in terms of demographic data (age and tooth number) except&#xD;
      for gender (P &gt; .05). During in this study, no patient reported swelling, sinus tract,&#xD;
      palpation pain and didn't need analgesics both in groups.Within the limitations of the&#xD;
      present study, LLLT can decrease postoperative pain after root canal treatment of single&#xD;
      rooted teeth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 12, 2018</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>
    <intervention_model_description>This study was designed as a randomized, placebo-controlled trial of 2 groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>All procedures were conducted by one clinician , and assignment was concealed from the clinician who performed the laser applications.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Evaluation</measure>
    <time_frame>3 day</time_frame>
    <description>Postoperative pain was measured and documented via the Visual Analogue Scale (VAS). VAS consists of a 100 mm line which is represented at one end by a sign 'No pain' and at the other end 'unbearable pain'.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>laser group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low level laser was applied for 60 second per tooth using Nd-YAG laser.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The same procedures as in the laser group were performed, been completed but the laser was not activated in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser</intervention_name>
    <description>Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth</description>
    <arm_group_label>laser group</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Root canal treatment was planned for patients who participated in this study and have&#xD;
             single root and single canal. Patients aged between 15 to 45 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria related with teeth were swelling or sinus tract, acute pain,&#xD;
             periodontal probing greater than 3mm, internal and external resorption, fractured and&#xD;
             cracked tooth, percussion sensitivity, and periapical index classification 3, 4, 5&#xD;
             according to Orstavik et al. (1986).&#xD;
&#xD;
          -  Exclusion criteria related with systemic health of patients included diabetes,&#xD;
             hypertension and cardiovascular pathologies, the use of analgesics and / or&#xD;
             antibiotics at least one week before treatment, and using antidepressant drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ELİF BAHAR ÇAKICI, ASST. PROF.</last_name>
    <role>Principal Investigator</role>
    <affiliation>T.C. ORDU ÜNİVERSİTESİ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ordu University</name>
      <address>
        <city>Ordu</city>
        <zip>52100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Adem Günaydin</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <keyword>laser</keyword>
  <keyword>pulpitis</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03748498
org study id: ag134134
nct id: NCT03748498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was designed as a randomized, placebo-controlled trial of 2 groups. The treatment
      procedures were performed by one operator. After local anesthesia and rubber dam isolation,
      access cavity preparation was performed by diamond burs with high-speed hand pieces under the
      water cooling. . Instrumentation of procedures was performed by Reciproc R50 files.
      Irrigation protocol was completed, canal were dried, filled with gutta-percha cones and AH
      Plus sealer. After chemo- mechanical instrumentation and root canal filling procedures, LLLT
      was applied for 60 second per tooth using Nd-YAG laser ( λ=1064 nm,100 mJ, 10 Hz, 1-W) The
      same procedures as in the laser group were performed, been completed but the laser was not
      activated in this group. These patients were assigned as placebo group. Postoperative pain
      was measured and documented via the Visual Analogue Scale. Chi-square test was performed in
      analysis of the nominal data.There was statistically significant difference between groups at
      the 12th and 24th hours (p<.05). ). However, no statistically significant difference was
      found between the groups at the 4th, 8th, 48th, and 72th hours (p>.05). No statistically
      significant differences were detected between the groups in terms of demographic data (age
      and tooth number) except for gender (P > .05).LLLT can decrease postoperative pain after root
      canal treatment of single rooted teeth.
The study was approved by the local ethics committee ....................., and informed
      consent was received from all participants. Study subjects were selected among patients who
      presented to the Department of Endodontics, Faculty of Dentistry ........................from
      September 2017 to March 2018.

      Root canal treatment was planned for patients who participated in this study and have single
      root and single canal. Patients aged between 15 to 45 years. Exclusion criteria related with
      teeth were swelling or sinus tract, acute pain, periodontal probing greater than 3mm,
      internal and external resorption, fractured and cracked tooth, percussion sensitivity, and
      periapical index classification 3, 4, 5 according to Orstavik et al. (1986). Exclusion
      criteria related with systemic health of patients included diabetes, hypertension and
      cardiovascular pathologies, the use of analgesics and / or antibiotics at least one week
      before treatment, and using antidepressant drugs.The treatment procedures were performed by
      one operator (G.A.). Initially, patients' age, gender, and tooth number were recorded by the
      operator. 1.5 mL 2% articaine with 0.012 mg epinephrine (Ultracaine DS Forte; Aventis,
      Istanbul, Turkey) was used as local anesthetic. After rubber dam isolation, access cavity
      preparation was performed by diamond burs (ADIA Dental Burs, Turkey) with high-speed hand
      pieces under the water cooling. A #10 K- type (Kerr Corporation, Orange, CA) file was
      inserted to root canal to determine working length using an apex locator (Raypex, VDW).
      Working length was set as 1 mm shorter than the apical foramen and confirmed with periapical
      radiographs. Instrumentation of procedures was performed by Reciproc R50 files (VDW, Munich,
      Germany). Irrigation protocol was completed 5 mL 17% EDTA (Werax, Turkey) and 15 mL 2.5%
      sodium hypochlorite (NaOCl)(Wizard, Turkey ) with a side-vented needle (NaviTip needle;
      Ultradent Products Inc, South Jordan, UT). Subsequently, canal were dried with paper points
      and filled with gutta-percha cones and AH Plus sealer (Dentsply Maillefer). Lateral cold
      condensation technique was used for obturation. Finally, coronal access cavity was restored
      with a temporary restorative material (Cavit G; 3M ESPE, St Paul, MN). Permanent restoration
      was completed after the end of the experiment.A randomization was produced using through a
      website (http://www.random.org), after the clinician (G.A.) was completed all treatment
      procedures. All procedures were conducted by one clinician (C.E.B.), and assignment was
      concealed from the clinician who performed the laser applications (U.B.). Data analysis and
      interpretation were completed by the other researcher (C.F.) After chemo- mechanical
      instrumentation and root canal filling procedures, LLLT was applied for 60 second per tooth
      using Nd-YAG laser ( λ=1064 nm,100 mJ, 10 Hz, 1-W[Deka smart file, DEKA, Italy]). Application
      of the laser was performed through root canal and to the buccal mucosa over the apices of the
      target tooth. An application biostimulation tip was used to ensure a constant distance of 10
      mm to the tissue.The same procedures as in the laser group were performed, been completed but
      the laser was not activated in this group. These patients were assigned as placebo
      group.Postoperative pain was measured and documented via the Visual Analogue Scale (VAS). VAS
      consists of a 100 mm line which is represented at one end by a sign 'No pain' and at the
      other end 'unbearable pain'. This form was given to the each patient and they were instructed
      to mark according to the pain intensity at 4th, 8th, 12th, 24th, 48th and 72th hours.There
      was statistically significant difference between groups at the 12th and 24th hours (p<.05).
      However, no statistically significant difference was found between the groups at the 4th,
      8th, 48th, and 72th hours (p>.05). Aside from sex, No statistically significant differences
      were detected between the groups in terms of demographic data (age and tooth number) except
      for gender (P > .05). During in this study, no patient reported swelling, sinus tract,
      palpation pain and didn't need analgesics both in groups.Within the limitations of the
      present study, LLLT can decrease postoperative pain after root canal treatment of single
      rooted teeth.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study was designed as a randomized, placebo-controlled trial of 2 groups.
primary purpose: Treatment
masking: Single (Investigator)
masking description: All procedures were conducted by one clinician , and assignment was concealed from the clinician who performed the laser applications.
measure: Pain Evaluation
time frame: 3 day
description: Postoperative pain was measured and documented via the Visual Analogue Scale (VAS). VAS consists of a 100 mm line which is represented at one end by a sign 'No pain' and at the other end 'unbearable pain'.
arm group label: laser group
arm group type: Experimental
description: Low level laser was applied for 60 second per tooth using Nd-YAG laser.
arm group label: placebo group
arm group type: Placebo Comparator
description: The same procedures as in the laser group were performed, been completed but the laser was not activated in this group.
intervention type: Device
intervention name: laser
description: Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth
arm group label: laser group
arm group label: placebo group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ELİF BAHAR ÇAKICI, ASST. PROF.
role: Principal Investigator
affiliation: T.C. ORDU ÜNİVERSİTESİ
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Adem Günaydin
investigator title: research assistant
mesh term: Pain, Postoperative
sharing ipd: Undecided