<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/NCT03841370</url>
  </required_header>
  <id_info>
    <org_study_id>FUPel</org_study_id>
    <nct_id>NCT03841370</nct_id>
  </id_info>
  <brief_title>Tooth Crown Discoloration Caused by Endodontic Treatment</brief_title>
  <official_title>Tooth Crown Discoloration Caused by Endodontic Treatment: Cross-sectional Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Pelotas</source>
  <brief_summary>
    <textblock>
      The color change of endodontically treated teeth is a common concern in clinical practice.&#xD;
      The objective of this study will be to evaluate, in vivo, the color change (ΔE00) caused by&#xD;
      endodontic treatment. A observational retrospective study will be conducted to evaluate the&#xD;
      ΔE00 of anterior (incisors and canines) and posterior (premolar) teeth treated at a private&#xD;
      clinic, regardless of technique, treatment time and sealer used. In this study the ΔE00 will&#xD;
      be evaluated using the measurements obtained in the homologous tooth (without endodontic&#xD;
      treatment) versus the measurement obtained from the tooth treated endodontically. The values&#xD;
      of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to&#xD;
      verify associations of the outcomes with the ΔE00.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cross-sectional clinical study will evaluate the color difference (∆E00), and CIELAB&#xD;
      coordinates (L*, a*, and b*) of endodontic treated teeth in the 3 conditions (baseline,&#xD;
      homologous tooth versus ≤ 1 month after tooth endodontic treatment); (baseline, homologous&#xD;
      tooth versus &gt; 1 to 12 months after tooth endodontic treatment); (baseline, homologous tooth&#xD;
      versus &gt; 12 up to 5 years after tooth endodontic treatment). The following pairs of variables&#xD;
      will be considered in the comparisons: filling material (AH Plus and Endofill/Fillcanal/MTA&#xD;
      Fillapex); cut at cervical level (dental cervix and 2mm in the apical direction); and&#xD;
      location tooth (anterior and posterior teeth).&#xD;
&#xD;
      The response variables will include the color difference (∆E00), estimated by the CIEDE2000&#xD;
      color difference metric (ΔE00) obtained from readings made on the homologous tooth of the&#xD;
      endodontic treated (baseline) and tooth endodontic treated (after) with a spectrophotometer.&#xD;
&#xD;
      All individuals who came to a private dental clinic between January 2010 and December 2018&#xD;
      and who received endodontic treatment will be considered for participation in this study. The&#xD;
      following inclusion criteria will be used to evaluate and enroll potential participants:&#xD;
      individuals at least 18 years old; who received anterior or posterior (pre-molar) endodontic&#xD;
      treatment and who present homologous tooth with pulp vitality and at least 1/3 of the&#xD;
      remaining coronary, without endodontic treatment, intraradicular retentor or crown making&#xD;
      dental color assessment impossible. Besides, will be excluded questionnaires filled&#xD;
      incorrectly or lack of data regarding, the day, month and year of endodontic treatment&#xD;
      finish, sealer used, the pulp condition at the time of the first consultation (irreversible&#xD;
      pulpitis or pulpal necrosis) and periapical radiography, obtained with the use of&#xD;
      radiographic positioner, preserved and with a clear image. All individuals who agree to&#xD;
      participate in the study will sign a consent form based on the Declaration of Helsinki, after&#xD;
      receiving information about the study objectives, risks, and benefits associated with the&#xD;
      alternative treatment options and procedures. One examiner will be trained and calibrated&#xD;
      prior to data collection. Kappa statistics will be used to assess intra-examiner reliability.&#xD;
      Clinical, radiographic and color information will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Color alteration</measure>
    <time_frame>ranging from 1 month to 5 years after endodontic treatment.</time_frame>
    <description>Color alteration (CIEDE2000 color difference metric - ΔE00) will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Endodontically Treated Teeth</condition>
  <condition>Root Canal Infection</condition>
  <condition>Tooth Discoloration</condition>
  <arm_group>
    <arm_group_label>endodontic</arm_group_label>
    <description>The color of anterior (incisors and canines) and posterior (premolar) teeth treated at a private clinic in the city of Pelotas will be evaluated. Data will be collected regardless of technique, treatment time and sealer used.&#xD;
The ΔE00 will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically.&#xD;
The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endodontic treatment</intervention_name>
    <description>Color measurements of endodontically treated teeth (incisors, canines or premolar) will be collected regardless of technique, treatment time and sealer used.</description>
    <arm_group_label>endodontic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent endodontic treatment and who presented the homologous tooth without&#xD;
        endodontic treatment in order to perform a color comparison measurement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  endodontically treated tooth, without intraradicular retainer and fixation;&#xD;
&#xD;
          -  presence of homologous tooth to that treated, with pulp vitality and at least 1/3 of&#xD;
             the crown;&#xD;
&#xD;
          -  correctly patient's file showing the endodontic treatment day, the endodontic filler&#xD;
             used, the pulp condition at the first consultation, and periapical radiography,&#xD;
             obtained with the use of a radiographic positioner, preserved and with a clear apical&#xD;
             image&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dental elements submitted to retreatment;&#xD;
&#xD;
          -  files with insufficient data, and absence of quality periapical radiography&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noéli Boscato, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Pelotas</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96015-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>Noéli Boscato, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Nonvital</mesh_term>
    <mesh_term>Tooth Discoloration</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/NCT03841370
org study id: FUPel
nct id: NCT03841370
lead sponsor: 
The color change of endodontically treated teeth is a common concern in clinical practice.
      The objective of this study will be to evaluate, in vivo, the color change (ΔE00) caused by
      endodontic treatment. A observational retrospective study will be conducted to evaluate the
      ΔE00 of anterior (incisors and canines) and posterior (premolar) teeth treated at a private
      clinic, regardless of technique, treatment time and sealer used. In this study the ΔE00 will
      be evaluated using the measurements obtained in the homologous tooth (without endodontic
      treatment) versus the measurement obtained from the tooth treated endodontically. The values
      of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to
      verify associations of the outcomes with the ΔE00.
This cross-sectional clinical study will evaluate the color difference (∆E00), and CIELAB
      coordinates (L*, a*, and b*) of endodontic treated teeth in the 3 conditions (baseline,
      homologous tooth versus ≤ 1 month after tooth endodontic treatment); (baseline, homologous
      tooth versus > 1 to 12 months after tooth endodontic treatment); (baseline, homologous tooth
      versus > 12 up to 5 years after tooth endodontic treatment). The following pairs of variables
      will be considered in the comparisons: filling material (AH Plus and Endofill/Fillcanal/MTA
      Fillapex); cut at cervical level (dental cervix and 2mm in the apical direction); and
      location tooth (anterior and posterior teeth).

      The response variables will include the color difference (∆E00), estimated by the CIEDE2000
      color difference metric (ΔE00) obtained from readings made on the homologous tooth of the
      endodontic treated (baseline) and tooth endodontic treated (after) with a spectrophotometer.

      All individuals who came to a private dental clinic between January 2010 and December 2018
      and who received endodontic treatment will be considered for participation in this study. The
      following inclusion criteria will be used to evaluate and enroll potential participants:
      individuals at least 18 years old; who received anterior or posterior (pre-molar) endodontic
      treatment and who present homologous tooth with pulp vitality and at least 1/3 of the
      remaining coronary, without endodontic treatment, intraradicular retentor or crown making
      dental color assessment impossible. Besides, will be excluded questionnaires filled
      incorrectly or lack of data regarding, the day, month and year of endodontic treatment
      finish, sealer used, the pulp condition at the time of the first consultation (irreversible
      pulpitis or pulpal necrosis) and periapical radiography, obtained with the use of
      radiographic positioner, preserved and with a clear image. All individuals who agree to
      participate in the study will sign a consent form based on the Declaration of Helsinki, after
      receiving information about the study objectives, risks, and benefits associated with the
      alternative treatment options and procedures. One examiner will be trained and calibrated
      prior to data collection. Kappa statistics will be used to assess intra-examiner reliability.
      Clinical, radiographic and color information will be collected.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Color alteration
time frame: ranging from 1 month to 5 years after endodontic treatment.
description: Color alteration (CIEDE2000 color difference metric - ΔE00) will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically.
arm group label: endodontic
description: The color of anterior (incisors and canines) and posterior (premolar) teeth treated at a private clinic in the city of Pelotas will be evaluated. Data will be collected regardless of technique, treatment time and sealer used.
The ΔE00 will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically.
The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.
intervention type: Procedure
intervention name: endodontic treatment
description: Color measurements of endodontically treated teeth (incisors, canines or premolar) will be collected regardless of technique, treatment time and sealer used.
arm group label: endodontic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Noéli Boscato, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: Noéli Boscato, PhD
investigator title: Professor
mesh term: Tooth, Nonvital
mesh term: Tooth Discoloration