<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/NCT03243357</url>
  </required_header>
  <id_info>
    <org_study_id>68089517.2.0000.5152</org_study_id>
    <nct_id>NCT03243357</nct_id>
  </id_info>
  <brief_title>In Vivo Assessment of Endodontics Procedures</brief_title>
  <official_title>In Vivo Assessment of Endodontics Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</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>
      In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would&#xD;
      be that the choose of this system based on the anatomical characteristics of the canal and&#xD;
      the biological precepts. In teeth with lesions, contaminated dentin should be removed.&#xD;
      However, in many systems, the manufacturer's approach disregards the fact that in wider root&#xD;
      canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch&#xD;
      the walls at the final apical. Therefore, the establishment of the initial apical file (LAI),&#xD;
      the first instrument that measures the resistance of the walls in working length, could be a&#xD;
      criterion in the choice of which system to use, and how many files work within the root&#xD;
      canals after LAI determination. However, there is a lack of studies that demonstrate that LAI&#xD;
      determination affects the degree of cleaning achieved, as well as the impact that LAI-based&#xD;
      instrumentation may have on microcracks formation, canal transportation, postoperative pain&#xD;
      and quality of obturation.In this way, the investigators propose a study in vivo performed,&#xD;
      in patients from 8 to 18 years of age, therefore in large root canals. The protocol&#xD;
      recommended by the manufacturer will be compared by means of a prospective randomized&#xD;
      clinical trial, with the addition of the XP Endo finisher and with the protocol based on the&#xD;
      initial apical file evaluating postoperative pain, exacerbation between the sessions, the&#xD;
      quality of the obturation and periapical radiolucency repair. Considering that currently&#xD;
      performing endodontic treatments using mechanized instruments is taught in undergraduate&#xD;
      courses throughout the country, studies of this nature help the execution of a endodontics&#xD;
      more critical and effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infected root canal treatments will be performed in two sessions with a TF Adaptive system&#xD;
      (Protocol recommended by manufacturer (Group Control) vs. Protocol based on the initial&#xD;
      apical file). The root canals will be completed after 14 days. Patients will record&#xD;
      postoperative pain during the follow-up period (7 days) using a Visual analogue scale (VAS)&#xD;
      and the change in periapical radiolucency will be assessed by periapical index (PAI) scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 22, 2017</start_date>
  <completion_date type="Anticipated">November 3, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 7, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain level</measure>
    <time_frame>7 days</time_frame>
    <description>A Visual Analogue Scale VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periapical radiolucence Repair</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>The change will be observed in periapical radiolucence in X-ray at the 6 and 12-month follow-up visit to assess the treatment outcome The outcome measure will be the change in periapical radiolucency as assessed by periapical index (PAI) scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Apical Periodontitis</condition>
  <arm_group>
    <arm_group_label>TF Adaptive (First Apical Binding File)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endodontic treatment(teeth with periapical periodontitis&amp;radiolucence).Local anesthesia (4%Articaine with1:100,000 epinephrine),isolation with rubber dam&amp;standard access cavity preparation.Using 2.5 %sodium hypochlorite,canal negotiation,glide path,coronal flaring with Sx(ProTaper),determining working length&amp;first apical binding file.Intervention: Root canal instrumentation:TF Adaptive system with enlargement of the root canal performed with up to 3 files larger than the diameter of the initial apical file. Irrigation2.5%NaOCl&amp;EDTA (Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, obturation: gutta-percha&amp;epoxy resin sealer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TF Adaptive (Control)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the control group,endodontic treatment (teeth with periapical periodontitis&amp;radiolucence). Local anesthesia(4% Articaine with 1:100,000 epinephrine), isolation with rubber dam&amp;standard access cavity preparation. Using 2.5 % sodium hypochlorite, canal negotiation, determining working length&amp;glide path. Root canal instrumentation:TF Adaptive system according to the protocol recommended by the manufacturer.Irrigation 2.5% NaOCl &amp; EDTA(Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, the canals will be obturated with gutta-percha and epoxy resin sealer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TF Adaptive (First Apical Binding File)</intervention_name>
    <description>Procedure: TF Adaptive System NiTi (Nickel titanium) Endo File System (SybronEndo) The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).&#xD;
Procedure: Instrumentation based on protocol of First Apical Binding File The enlargement of the root canal will be performed with three files larger than the diameter of the previously established initial apical file.</description>
    <arm_group_label>TF Adaptive (First Apical Binding File)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TF Adaptive (Control)</intervention_name>
    <description>Procedure: TF Adaptive System NiTi (Nickel titanium)Endo File System The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).&#xD;
Procedure: Instrumentation based on manufacturer's protocol The enlargement of the root canal will be performed according to the manufacturer's directions.</description>
    <arm_group_label>TF Adaptive (Control)</arm_group_label>
    <other_name>TF Adaptive (Manufacturer's protocol)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have in their mandibular or maxillary molar teeth apical&#xD;
             periodontitis symptomatic or asymptomatic with apical radiolucence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with medical history compromises outcomes&#xD;
&#xD;
          -  Atresic and root canals&#xD;
&#xD;
          -  Root canals with curvature greater than 30 degrees&#xD;
&#xD;
          -  Previously performed endodontics treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camilla C Gomes Moura, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Uberlandia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Camilla C Gomes Moura, PhD</last_name>
    <phone>+55 34 99924 9586</phone>
    <email>camillahistologia@yahoo.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thaís C Cunha, Ms</last_name>
    <phone>+55 34 99172 1990</phone>
    <email>christina.thais@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Federal University of Uberlandia</name>
      <address>
        <city>Uberlândia</city>
        <state>Minas Gerais</state>
        <zip>38405-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camilla C Gomes Moura, PhD</last_name>
      <phone>+55 34 99924 9586</phone>
      <email>camillahistologia@yahoo.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Thaís C Cunha, Ms</last_name>
      <phone>+55 34 99172 1990</phone>
      <email>christina.thais@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 18, 2019</last_update_submitted>
  <last_update_submitted_qc>May 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Camilla Christian Gomes Moura</investigator_full_name>
    <investigator_title>Adjunct Professor of Endodontics of Faculty of Dentistry of Federal University of Uberlandia</investigator_title>
  </responsible_party>
  <keyword>Endodontics, molars, instrumentation, obturation, anatomy</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>
  </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/NCT03243357
org study id: 68089517.2.0000.5152
nct id: NCT03243357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would
      be that the choose of this system based on the anatomical characteristics of the canal and
      the biological precepts. In teeth with lesions, contaminated dentin should be removed.
      However, in many systems, the manufacturer's approach disregards the fact that in wider root
      canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch
      the walls at the final apical. Therefore, the establishment of the initial apical file (LAI),
      the first instrument that measures the resistance of the walls in working length, could be a
      criterion in the choice of which system to use, and how many files work within the root
      canals after LAI determination. However, there is a lack of studies that demonstrate that LAI
      determination affects the degree of cleaning achieved, as well as the impact that LAI-based
      instrumentation may have on microcracks formation, canal transportation, postoperative pain
      and quality of obturation.In this way, the investigators propose a study in vivo performed,
      in patients from 8 to 18 years of age, therefore in large root canals. The protocol
      recommended by the manufacturer will be compared by means of a prospective randomized
      clinical trial, with the addition of the XP Endo finisher and with the protocol based on the
      initial apical file evaluating postoperative pain, exacerbation between the sessions, the
      quality of the obturation and periapical radiolucency repair. Considering that currently
      performing endodontic treatments using mechanized instruments is taught in undergraduate
      courses throughout the country, studies of this nature help the execution of a endodontics
      more critical and effective.
Infected root canal treatments will be performed in two sessions with a TF Adaptive system
      (Protocol recommended by manufacturer (Group Control) vs. Protocol based on the initial
      apical file). The root canals will be completed after 14 days. Patients will record
      postoperative pain during the follow-up period (7 days) using a Visual analogue scale (VAS)
      and the change in periapical radiolucency will be assessed by periapical index (PAI) scores.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain level
time frame: 7 days
description: A Visual Analogue Scale VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.
measure: Periapical radiolucence Repair
time frame: 6 and 12 months
description: The change will be observed in periapical radiolucence in X-ray at the 6 and 12-month follow-up visit to assess the treatment outcome The outcome measure will be the change in periapical radiolucency as assessed by periapical index (PAI) scores.
arm group label: TF Adaptive (First Apical Binding File)
arm group type: Experimental
description: Endodontic treatment(teeth with periapical periodontitis&radiolucence).Local anesthesia (4%Articaine with1:100,000 epinephrine),isolation with rubber dam&standard access cavity preparation.Using 2.5 %sodium hypochlorite,canal negotiation,glide path,coronal flaring with Sx(ProTaper),determining working length&first apical binding file.Intervention: Root canal instrumentation:TF Adaptive system with enlargement of the root canal performed with up to 3 files larger than the diameter of the initial apical file. Irrigation2.5%NaOCl&EDTA (Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, obturation: gutta-percha&epoxy resin sealer.
arm group label: TF Adaptive (Control)
arm group type: Other
description: In the control group,endodontic treatment (teeth with periapical periodontitis&radiolucence). Local anesthesia(4% Articaine with 1:100,000 epinephrine), isolation with rubber dam&standard access cavity preparation. Using 2.5 % sodium hypochlorite, canal negotiation, determining working length&glide path. Root canal instrumentation:TF Adaptive system according to the protocol recommended by the manufacturer.Irrigation 2.5% NaOCl & EDTA(Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, the canals will be obturated with gutta-percha and epoxy resin sealer.
intervention type: Procedure
intervention name: TF Adaptive (First Apical Binding File)
description: Procedure: TF Adaptive System NiTi (Nickel titanium) Endo File System (SybronEndo) The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).
Procedure: Instrumentation based on protocol of First Apical Binding File The enlargement of the root canal will be performed with three files larger than the diameter of the previously established initial apical file.
arm group label: TF Adaptive (First Apical Binding File)
intervention type: Procedure
intervention name: TF Adaptive (Control)
description: Procedure: TF Adaptive System NiTi (Nickel titanium)Endo File System The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).
Procedure: Instrumentation based on manufacturer's protocol The enlargement of the root canal will be performed according to the manufacturer's directions.
arm group label: TF Adaptive (Control)
other name: TF Adaptive (Manufacturer's protocol)
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Camilla C Gomes Moura, PhD
role: Principal Investigator
affiliation: Federal University of Uberlandia
last name: Camilla C Gomes Moura, PhD
phone: +55 34 99924 9586
email: camillahistologia@yahoo.com.br
last name: Thaís C Cunha, Ms
phone: +55 34 99172 1990
email: christina.thais@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Camilla Christian Gomes Moura
investigator title: Adjunct Professor of Endodontics of Faculty of Dentistry of Federal University of Uberlandia
mesh term: Periodontitis
mesh term: Periapical Periodontitis