<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/NCT04482101</url>
  </required_header>
  <id_info>
    <org_study_id>postoperative pain</org_study_id>
    <nct_id>NCT04482101</nct_id>
  </id_info>
  <brief_title>Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers</brief_title>
  <official_title>Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers : A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      The aim of this randomized clinical trial was to compare the potential effects of resin-based&#xD;
      and bio ceramic sealers on the occurrence and intensity of postoperative pain in patients&#xD;
      with asymptomatic apical periodontitis (AAP) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reports about postoperative pain in endodontics range from 3%-58% in different studies .&#xD;
&#xD;
      Pain can be provoked by mechanical, chemical, or microbiological injuries to periodontal&#xD;
      tissues . A number of treatment related parameters have been shown to be associated with the&#xD;
      presence of postoperative pain, including working length (WL) estimation with an apex locator&#xD;
      connected to every file , the number of visits , the choice of instrumentation , and the&#xD;
      choice of root canal sealer .&#xD;
&#xD;
      Sealers placed in the root canals interfere with periodontal tissues through the apical&#xD;
      foramina, lateral canals, or leaching and can potentially affect the healing process in the&#xD;
      periodontium. Thus, the local inflammation caused by root canal obturation materials may&#xD;
      result in postoperative pain. The intensity of inflammatory reactions depends on a number of&#xD;
      different factors, including the composition of the sealer .&#xD;
&#xD;
      The use of a sealer during root canal obturation is essential for success of root canal&#xD;
      treatment. The sealer has various functions:&#xD;
&#xD;
        -  Attainment of impervious seal&#xD;
&#xD;
        -  Filler for canal irregularities and minor discrepancies between the root canal wall and&#xD;
           core-filling material Expressed through lateral or accessory canals&#xD;
&#xD;
        -  Can assist in microbial control&#xD;
&#xD;
        -  Act as lubricant&#xD;
&#xD;
        -  Can have adhesive property to dentin&#xD;
&#xD;
      The evolution of newer techniques, instruments, materials, and better understanding of canal&#xD;
      anatomy, has changed the face of endodontics completely. One concept that has emerged is the&#xD;
      single-visit root canal therapy. Single-visit root canal treatment (RCT) has become a common&#xD;
      practice and offers several advantages, including a reduced flare-up rate, decreased number&#xD;
      of operative procedures, and no risk of interappointment leakage through temporary&#xD;
      restorations.&#xD;
&#xD;
      The major consideration regarding one-appointment endodontics has been the concern about&#xD;
      postoperative pain . Various studies have evaluated the post-endodontic pain difference&#xD;
      between single- and multiple-visit RCT, but most studies have ruled out any significant&#xD;
      difference in postoperative pain .&#xD;
&#xD;
      It has been suggested that bioceramic materials improve the outcome of endodontic treatment&#xD;
      by promoting the differentiation of odontoblasts and by releasing biologically active&#xD;
      substances . The bioceramic materials have been shown to be less cytotoxic compared with&#xD;
      resin-based AH Plus (Dentsply Maillefer, Ballaigues, Switzerland) in vitro . However, AH Plus&#xD;
      (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) exhibited stronger bonding capacity and&#xD;
      higher radiopacity compared with bioceramic sealers. The clinical significance of these&#xD;
      characteristics is still unclear. Data on the clinical behavior of bioceramic sealers are&#xD;
      scarce and of great interest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of postoperative pain</measure>
    <time_frame>6th hours</time_frame>
    <description>Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of postoperative pain</measure>
    <time_frame>12th hours</time_frame>
    <description>Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of postoperative pain</measure>
    <time_frame>24th hours</time_frame>
    <description>Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intensity of postoperative pain</measure>
    <time_frame>48th hours</time_frame>
    <description>Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intensity of postoperative pain</measure>
    <time_frame>72nd hours</time_frame>
    <description>Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intensity of postoperative pain</measure>
    <time_frame>5th day</time_frame>
    <description>Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Ah-Plus sealer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal sealer which is a resin-based formula with excellent radiopacity , low shrinkage , low solubility and outstanding flow characteristics .&#xD;
It features a 1:1 , paste-to-paste mixing system for fast , easy preparation and less waste . It is biocompatible and silver free .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endosequence BC sealer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is a root canal sealer which is premixed ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications.&#xD;
It is insoluble , radiopaque and aluminum-free material based on calcium silicate composition , which requires the presence of water to set and hardens . It does not shrink during setting and demonstrate excellent physical properties .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root canal obturation</intervention_name>
    <description>Root canal filling</description>
    <arm_group_label>Ah-Plus sealer</arm_group_label>
    <arm_group_label>Endosequence BC sealer</arm_group_label>
    <other_name>Root canal sealer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Permanent teeth with fully formed apex&#xD;
&#xD;
          -  Teeth with vital pulp&#xD;
&#xD;
          -  Teeth with no periapical radiolucency&#xD;
&#xD;
          -  Patients having preoperative pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teeth with incompletely formed apex&#xD;
&#xD;
          -  Teeth requiring secondary endodontic treatment&#xD;
&#xD;
          -  Patients having complicating systemic disease such as diabetes, malignancy, pregnancy,&#xD;
             central nervous system disorders, Cardiovascular system disorders, respiratory&#xD;
             disorders, asthma patients, psychiatric disorders, immunocompromised patients,&#xD;
&#xD;
          -  Patients taking anti-inflammatory or antibiotics&#xD;
&#xD;
          -  Patients giving history of analgesic or antibiotic intake 1 week before treatment&#xD;
&#xD;
          -  Patients below 18 years of age,&#xD;
&#xD;
          -  Patients above 65 years of age&#xD;
&#xD;
          -  Patients having history of peptic ulcer or gastrointestinal bleeding,&#xD;
&#xD;
          -  Teeth having calcified canals,&#xD;
&#xD;
          -  Teeth having multiple canals or multirooted teeth,&#xD;
&#xD;
          -  Teeth affected with periodontal disease.&#xD;
&#xD;
          -  Teeth tender on percussion,&#xD;
&#xD;
          -  Teeth having procedural errors such as transportation, perforation, and missed canals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hany Sadek, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muna Mohamed, master</last_name>
    <phone>00201277974490</phone>
    <email>muna.abubaker@dentisrty.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heba ElAsfouri, PHD</last_name>
  </overall_contact_backup>
  <results_reference>
    <citation>Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.</citation>
    <PMID>29571915</PMID>
  </results_reference>
  <results_reference>
    <citation>Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.</citation>
    <PMID>30397735</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Muna Abubaker Beshir Mohamed</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- 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/NCT04482101
org study id: postoperative pain
nct id: NCT04482101
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized clinical trial was to compare the potential effects of resin-based
      and bio ceramic sealers on the occurrence and intensity of postoperative pain in patients
      with asymptomatic apical periodontitis (AAP) .
Reports about postoperative pain in endodontics range from 3%-58% in different studies .

      Pain can be provoked by mechanical, chemical, or microbiological injuries to periodontal
      tissues . A number of treatment related parameters have been shown to be associated with the
      presence of postoperative pain, including working length (WL) estimation with an apex locator
      connected to every file , the number of visits , the choice of instrumentation , and the
      choice of root canal sealer .

      Sealers placed in the root canals interfere with periodontal tissues through the apical
      foramina, lateral canals, or leaching and can potentially affect the healing process in the
      periodontium. Thus, the local inflammation caused by root canal obturation materials may
      result in postoperative pain. The intensity of inflammatory reactions depends on a number of
      different factors, including the composition of the sealer .

      The use of a sealer during root canal obturation is essential for success of root canal
      treatment. The sealer has various functions:

        -  Attainment of impervious seal

        -  Filler for canal irregularities and minor discrepancies between the root canal wall and
           core-filling material Expressed through lateral or accessory canals

        -  Can assist in microbial control

        -  Act as lubricant

        -  Can have adhesive property to dentin

      The evolution of newer techniques, instruments, materials, and better understanding of canal
      anatomy, has changed the face of endodontics completely. One concept that has emerged is the
      single-visit root canal therapy. Single-visit root canal treatment (RCT) has become a common
      practice and offers several advantages, including a reduced flare-up rate, decreased number
      of operative procedures, and no risk of interappointment leakage through temporary
      restorations.

      The major consideration regarding one-appointment endodontics has been the concern about
      postoperative pain . Various studies have evaluated the post-endodontic pain difference
      between single- and multiple-visit RCT, but most studies have ruled out any significant
      difference in postoperative pain .

      It has been suggested that bioceramic materials improve the outcome of endodontic treatment
      by promoting the differentiation of odontoblasts and by releasing biologically active
      substances . The bioceramic materials have been shown to be less cytotoxic compared with
      resin-based AH Plus (Dentsply Maillefer, Ballaigues, Switzerland) in vitro . However, AH Plus
      (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) exhibited stronger bonding capacity and
      higher radiopacity compared with bioceramic sealers. The clinical significance of these
      characteristics is still unclear. Data on the clinical behavior of bioceramic sealers are
      scarce and of great interest.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Intensity of postoperative pain
time frame: 6th hours
description: Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
measure: Intensity of postoperative pain
time frame: 12th hours
description: Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
measure: Intensity of postoperative pain
time frame: 24th hours
description: Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
measure: intensity of postoperative pain
time frame: 48th hours
description: Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
measure: intensity of postoperative pain
time frame: 72nd hours
description: Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
measure: intensity of postoperative pain
time frame: 5th day
description: Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
arm group label: Ah-Plus sealer
arm group type: Experimental
description: Root canal sealer which is a resin-based formula with excellent radiopacity , low shrinkage , low solubility and outstanding flow characteristics .
It features a 1:1 , paste-to-paste mixing system for fast , easy preparation and less waste . It is biocompatible and silver free .
arm group label: Endosequence BC sealer
arm group type: Experimental
description: It is a root canal sealer which is premixed ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications.
It is insoluble , radiopaque and aluminum-free material based on calcium silicate composition , which requires the presence of water to set and hardens . It does not shrink during setting and demonstrate excellent physical properties .
intervention type: Other
intervention name: Root canal obturation
description: Root canal filling
arm group label: Ah-Plus sealer
arm group label: Endosequence BC sealer
other name: Root canal sealer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hany Sadek, PHD
role: Study Director
affiliation: Cairo University
last name: Muna Mohamed, master
phone: 00201277974490
email: muna.abubaker@dentisrty.cu.edu.eg
last name: Heba ElAsfouri, PHD
citation: Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
PMID: 29571915
citation: Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.
PMID: 30397735
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Muna Abubaker Beshir Mohamed
investigator title: Principle investigator
mesh term: Pain, Postoperative