<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/NCT03042377</url>
  </required_header>
  <id_info>
    <org_study_id>156</org_study_id>
    <nct_id>NCT03042377</nct_id>
  </id_info>
  <brief_title>Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases</brief_title>
  <official_title>The Clinical Comparative Evaluation Of Postoperative Pain In Single-Visit And Multiple-Visit Pretreatment Cases: A Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</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>
      The purpose of this randomized clinical trial was to evaluate the incidence of postoperative&#xD;
      pain after retreatment using different techniques. Patients whom need retreatment were&#xD;
      included. The presence of postoperative pain was assessed after retreatment cases at 1, 6,&#xD;
      12, 24 and 48 hrs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this clinical study was to evaluate the intensity and duration of postoperative&#xD;
      pain after single-visit and multiple-visit root canal retreatment procedures. Patients who&#xD;
      have asymptomatic failed endodontically treated teeth were included in this study and routine&#xD;
      channel treatment procedure will be applied to these teeth. All of the patients have been&#xD;
      recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty&#xD;
      asymptomatic teeth were randomly participated into four treatment groups in terms of&#xD;
      intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6,&#xD;
      12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue&#xD;
      pain scale. Before the retreatments, the nature of the study, complications and associated&#xD;
      risks were totally explained and written informed consent was obtained from all study&#xD;
      participants. The patients were offered local anesthetic before the treatment start. The&#xD;
      routine root canal retreatment procedure was applied. Different intracanal medicaments used&#xD;
      between sessions in accordance to the manufacturers' instructions. At the end of retreatment,&#xD;
      each patient was given an evaluation sheet, explained the treatment procedure and using of&#xD;
      visual analogue pain scales, and informed to be returned during the following one week. After&#xD;
      one week the teeth was examined according to for pain intensity, percussion &amp; palpation&#xD;
      sensitivity, swelling, analgesic intake and clinical status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">August 30, 2015</completion_date>
  <primary_completion_date type="Actual">July 30, 2015</primary_completion_date>
  <phase>Phase 4</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>The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patients were unaware as to which study group they had been allocated.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Postoperative Pain after Retreatment at 48 hours.</measure>
    <time_frame>Baseline, 1, 6, 12, 24 and 48 hours.</time_frame>
    <description>The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Root Canal Infection</condition>
  <condition>Endodontic Disease</condition>
  <arm_group>
    <arm_group_label>Single-Visit Retreatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple-Visit-&quot;Calcium Hydroxide&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple-Visit-&quot;Corticosteroid Paste&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple-Visit-&quot;Antibiotic Paste&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single-Visit Retreatment</intervention_name>
    <description>The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.</description>
    <arm_group_label>Single-Visit Retreatment</arm_group_label>
    <other_name>Single-Visit Root Canal Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple-Visit-&quot;Calcium Hydroxide&quot;</intervention_name>
    <description>The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.</description>
    <arm_group_label>Multiple-Visit-&quot;Calcium Hydroxide&quot;</arm_group_label>
    <other_name>Calcium Hydroxide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple-Visit-&quot;Corticosteroid Paste&quot;</intervention_name>
    <description>The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid &amp; antibiotic paste and the cavity was filled with temporary restorative material.</description>
    <arm_group_label>Multiple-Visit-&quot;Corticosteroid Paste&quot;</arm_group_label>
    <other_name>Ledermix Paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple-Visit-&quot;Antibiotic Paste&quot;</intervention_name>
    <description>The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.</description>
    <arm_group_label>Multiple-Visit-&quot;Antibiotic Paste&quot;</arm_group_label>
    <other_name>Triple Antibiotic Paste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who were not included the study who;&#xD;
&#xD;
          -  were pregnant or breast feeding during the duration of the study,&#xD;
&#xD;
          -  have systemic disease,&#xD;
&#xD;
          -  have any pain and/or any facial swelling, abscess,&#xD;
&#xD;
          -  were immunocompromised,&#xD;
&#xD;
          -  were under 18 yrs. and over 65 yrs. age,&#xD;
&#xD;
          -  were taking antibiotics or corticosteroids within previous three months,&#xD;
&#xD;
          -  have multiple teeth that required retreatment at the same time period; for eliminating&#xD;
             pain referral,&#xD;
&#xD;
          -  have root canals that could not be well-treated with orthograde retreatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The patients who forgot to fill out the form and took antibiotics and/or analgesics right&#xD;
        after the first appointment of the therapy were excluded from the study.&#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>Keziban Olcay, DDS. PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medipol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <zip>34083</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>Keziban Olcay</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Endodontics</keyword>
  <keyword>Retreatment</keyword>
  <keyword>Postoperative Pain</keyword>
  <keyword>Visual Analogue Pain Scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
    <mesh_term>Calcium</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/NCT03042377
org study id: 156
nct id: NCT03042377
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative
      pain after retreatment using different techniques. Patients whom need retreatment were
      included. The presence of postoperative pain was assessed after retreatment cases at 1, 6,
      12, 24 and 48 hrs.
The aim of this clinical study was to evaluate the intensity and duration of postoperative
      pain after single-visit and multiple-visit root canal retreatment procedures. Patients who
      have asymptomatic failed endodontically treated teeth were included in this study and routine
      channel treatment procedure will be applied to these teeth. All of the patients have been
      recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty
      asymptomatic teeth were randomly participated into four treatment groups in terms of
      intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6,
      12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue
      pain scale. Before the retreatments, the nature of the study, complications and associated
      risks were totally explained and written informed consent was obtained from all study
      participants. The patients were offered local anesthetic before the treatment start. The
      routine root canal retreatment procedure was applied. Different intracanal medicaments used
      between sessions in accordance to the manufacturers' instructions. At the end of retreatment,
      each patient was given an evaluation sheet, explained the treatment procedure and using of
      visual analogue pain scales, and informed to be returned during the following one week. After
      one week the teeth was examined according to for pain intensity, percussion & palpation
      sensitivity, swelling, analgesic intake and clinical status.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
primary purpose: Treatment
masking: Single (Participant)
masking description: The patients were unaware as to which study group they had been allocated.
measure: Change from Baseline in Postoperative Pain after Retreatment at 48 hours.
time frame: Baseline, 1, 6, 12, 24 and 48 hours.
description: The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
arm group label: Single-Visit Retreatment
arm group type: Active Comparator
description: Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.
arm group label: Multiple-Visit-"Calcium Hydroxide"
arm group type: Active Comparator
description: Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
arm group label: Multiple-Visit-"Corticosteroid Paste"
arm group type: Active Comparator
description: Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
arm group label: Multiple-Visit-"Antibiotic Paste"
arm group type: Active Comparator
description: Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
intervention type: Other
intervention name: Single-Visit Retreatment
description: The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.
arm group label: Single-Visit Retreatment
other name: Single-Visit Root Canal Therapy
intervention type: Drug
intervention name: Multiple-Visit-"Calcium Hydroxide"
description: The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.
arm group label: Multiple-Visit-"Calcium Hydroxide"
other name: Calcium Hydroxide
intervention type: Drug
intervention name: Multiple-Visit-"Corticosteroid Paste"
description: The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid & antibiotic paste and the cavity was filled with temporary restorative material.
arm group label: Multiple-Visit-"Corticosteroid Paste"
other name: Ledermix Paste
intervention type: Drug
intervention name: Multiple-Visit-"Antibiotic Paste"
description: The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.
arm group label: Multiple-Visit-"Antibiotic Paste"
other name: Triple Antibiotic Paste
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keziban Olcay, DDS. PhD.
role: Principal Investigator
affiliation: Medipol University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: Keziban Olcay
investigator title: Assistant Professor
mesh term: Dental Pulp Diseases
mesh term: Pain, Postoperative
mesh term: Calcium, Dietary
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular
mesh term: Calcium
sharing ipd: No