<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/NCT04495270</url>
  </required_header>
  <id_info>
    <org_study_id>BE-2-27</org_study_id>
    <nct_id>NCT04495270</nct_id>
  </id_info>
  <brief_title>2-year Treatment Outcomes of Teeth Estimated by Means of Periapical and Endodontic Status Scale</brief_title>
  <official_title>Two-year Treatment Outcomes of Teeth With Apical Periodontitis Based on Cone-beam Computed Tomography and Estimated by Means of Periapical and Endodontic Status Scale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lithuanian University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lithuanian University of Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objectives: Evaluation of endodontic treatment success is largely based on radiographical&#xD;
      assessment of anatomical and treatment-related parameters of teeth with apical periodontitis&#xD;
      (AP). This study aimed to analyse 2-year treatment outcomes of teeth with AP based on&#xD;
      radiographical changes, and to evaluate prognostic validity of Periapical and Endodontic&#xD;
      Status Scale (PESS).&#xD;
&#xD;
      Materials and Methods: 128 patients (176 teeth) were examined by cone-beam computed&#xD;
      tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was&#xD;
      evaluated using estimates of periapical radiolucencies in size, relation with anatomical&#xD;
      structures and location. Strength of associations between these and treatment-related&#xD;
      parameters was tested by logistic regression analysis. Predictive validity of PESS was&#xD;
      verified by estimating association between treatment risk groups defined at baseline and&#xD;
      negative outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study sample The study participants were adult patients, admitted for general oral&#xD;
      rehabilitation to Vilnius Implantology Center, Lithuania, and referred for treatment to a&#xD;
      specialist in endodontics during the period December 2016 - December 2019. A total of 140&#xD;
      patients, with 200 teeth with AP, were invited to participate in the study. Ten patients were&#xD;
      excluded according to the inclusion criteria, and 2 patients declined to participate.&#xD;
      Finally, 128 patients with 176 teeth with AP, agreed to participate in this study. The mean&#xD;
      age of the participants was 46 years, range 18-70 years, (SD =12.3).&#xD;
&#xD;
      The inclusion criteria were as follows:&#xD;
&#xD;
        -  no systemic diseases present;&#xD;
&#xD;
        -  at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals)&#xD;
           present;&#xD;
&#xD;
        -  sufficient periodontal support (absence of clinical periodontal inflammation on an&#xD;
           anatomically intact or, on a reduced periodontium of the teeth indicated for treatment);&#xD;
&#xD;
        -  baseline CBCT images available (performed for general oral rehabilitation planning&#xD;
           purposes, no earlier than one month prior to endodontic procedures).&#xD;
&#xD;
      The diagnosis of apical periodontitis was based on the clinical tests of pulp vitality&#xD;
      (sensitivity to heat and cold), percussion, palpation, presence of abnormal bite, swelling,&#xD;
      caries, sinus tracts, of unstimulated/stimulated pain, and on the radiological findings. A&#xD;
      total of 176 teeth (403 root canals) were subjected to endodontic treatment.&#xD;
&#xD;
      Pregnant women, immunosuppressed patients, and patients presenting with un-restorable teeth&#xD;
      (e.g., deep root caries lesion, coronal cracks, root fracture) or, with the probing depths &gt;5&#xD;
      mm around the marginal bone were excluded.&#xD;
&#xD;
      All the participants gave written informed consent to be involved in the clinical trial. The&#xD;
      study protocol was approved by the Ethical Committee of Biomedical studies, Lithuania&#xD;
      (Protocol No 111; 10.03.2016; edition No BE-2-27; 20.12.2016).&#xD;
&#xD;
      Clinical and radiographic examinations:&#xD;
&#xD;
      All study patients were examined clinically and radiographically at baseline, and in 24&#xD;
      months (further on, referred as &quot;2 years&quot;) after endodontic treatment. The intermediate&#xD;
      follow-up examinations were set at 12 months' time point, however, only the final study&#xD;
      results are discussed in the present report.&#xD;
&#xD;
      The clinical examinations were performed by one examiner (JG) and included standard tests&#xD;
      such as percussion, palpation, evaluation of coronal seal, of tooth mobility and of the&#xD;
      periodontal probing depth. All diagnostic procedures were performed in a dental chair using a&#xD;
      dental mirror and explorer (Dentsply Maillefer, Ballaigues, Switzerland). The case history&#xD;
      (presence of clinical symptoms, complaints, the time of the previous treatment) was obtained&#xD;
      from every patient.&#xD;
&#xD;
      Radiographical examinations of the patients were performed with CBCT imaging, and with&#xD;
      digital radiography. For the present study purposes, only CBCT data were included in the&#xD;
      analysis. The baseline CBCT images were already available following the general diagnostic&#xD;
      and treatment plan. The follow-up CBCT was performed in 2 years after the endodontic&#xD;
      treatment, only for the respective maxillary or mandibular arch. All images were made with&#xD;
      i-CAT scanner (Imaging Sciences International Inc., Hatfield, PA, USA), the exposure&#xD;
      parameters were as follows: 84 kV, 5 mA, 0.3 mm voxel resolution, 6x16 and 6x6 cm field of&#xD;
      view, 18.3s and 5s acquisition time at baseline and at the final examination, respectively.&#xD;
      The CBCT images were viewed as an original i-Cat presentation (Apple, Cupertino, CA, USA) on&#xD;
      the computers with a 27-inch flat panel display with a pixel resolution of 2.560 x 1.440 with&#xD;
      dimmed ambient light, less than 50 lux, without time restrictions. A total of 256 (128&#xD;
      baseline and 128 follow up) CBCT images were coded and analyzed by the same examiner (JG),&#xD;
      without knowledge of the clinical data.&#xD;
&#xD;
      The radiographical assessment of the periapical status of the teeth was performed following&#xD;
      the Periapical and Endodontic Status Scale (PESS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>The positive treatment outcome</measure>
    <time_frame>24 months</time_frame>
    <description>Decreased periapical radiolucency, with respect to it's size, or/and relation with anatomical structures, location (respective parameters S, R, and D). Moreover, the unchanged mild severity scores S1, D1, and R1 were regarded as positive outcome as well. The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The negative treatment outcome</measure>
    <time_frame>24 months</time_frame>
    <description>Increased/unchanged periapical radiolucency in size, or/and in relation with anatomical structures, or/and in location (respective parameters S, R, and D). By comparing the baseline and the final CBCT images all transition events from the lower to the higher scores and the following unchanged scores were considered as negative treatment outcomes.The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>Periapical Periodontitis</condition>
  <condition>Treatment Outcome</condition>
  <arm_group>
    <arm_group_label>Clinical observation</arm_group_label>
    <description>All study patients were examined by 1 endodontist clinically and radiographically at baseline and after follow up of endodontic treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale&quot;</intervention_name>
    <description>Patients were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location.</description>
    <arm_group_label>Clinical observation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study participants were adult patients, admitted for general oral rehabilitation and&#xD;
        referred for treatment to a specialist in endodontics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no systemic diseases present;&#xD;
&#xD;
          -  at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals)&#xD;
             present;&#xD;
&#xD;
          -  sufficient periodontal support (absence of clinical periodontal inflammation on an&#xD;
             anatomically intact or, on a reduced periodontium [13] of the teeth indicated for&#xD;
             treatment);&#xD;
&#xD;
          -  baseline CBCT images available (performed for general oral rehabilitation planning&#xD;
             purposes, no earlier than one month prior to endodontic procedures).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women;&#xD;
&#xD;
          -  immunosuppressed patient&#xD;
&#xD;
          -  patients presenting with un-restorable teeth (e.g., deep root caries lesion, coronal&#xD;
             cracks, root fracture)&#xD;
&#xD;
          -  with the probing depths &gt;5 mm around the marginal bone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lithuanian University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Jelena Gudac</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cone-beam computed tomography</keyword>
  <keyword>Periapical periodontitis</keyword>
  <keyword>Scale</keyword>
  <keyword>Treatment outcome</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>
  <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/NCT04495270
org study id: BE-2-27
nct id: NCT04495270
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives: Evaluation of endodontic treatment success is largely based on radiographical
      assessment of anatomical and treatment-related parameters of teeth with apical periodontitis
      (AP). This study aimed to analyse 2-year treatment outcomes of teeth with AP based on
      radiographical changes, and to evaluate prognostic validity of Periapical and Endodontic
      Status Scale (PESS).

      Materials and Methods: 128 patients (176 teeth) were examined by cone-beam computed
      tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was
      evaluated using estimates of periapical radiolucencies in size, relation with anatomical
      structures and location. Strength of associations between these and treatment-related
      parameters was tested by logistic regression analysis. Predictive validity of PESS was
      verified by estimating association between treatment risk groups defined at baseline and
      negative outcome.
Study sample The study participants were adult patients, admitted for general oral
      rehabilitation to Vilnius Implantology Center, Lithuania, and referred for treatment to a
      specialist in endodontics during the period December 2016 - December 2019. A total of 140
      patients, with 200 teeth with AP, were invited to participate in the study. Ten patients were
      excluded according to the inclusion criteria, and 2 patients declined to participate.
      Finally, 128 patients with 176 teeth with AP, agreed to participate in this study. The mean
      age of the participants was 46 years, range 18-70 years, (SD =12.3).

      The inclusion criteria were as follows:

        -  no systemic diseases present;

        -  at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals)
           present;

        -  sufficient periodontal support (absence of clinical periodontal inflammation on an
           anatomically intact or, on a reduced periodontium of the teeth indicated for treatment);

        -  baseline CBCT images available (performed for general oral rehabilitation planning
           purposes, no earlier than one month prior to endodontic procedures).

      The diagnosis of apical periodontitis was based on the clinical tests of pulp vitality
      (sensitivity to heat and cold), percussion, palpation, presence of abnormal bite, swelling,
      caries, sinus tracts, of unstimulated/stimulated pain, and on the radiological findings. A
      total of 176 teeth (403 root canals) were subjected to endodontic treatment.

      Pregnant women, immunosuppressed patients, and patients presenting with un-restorable teeth
      (e.g., deep root caries lesion, coronal cracks, root fracture) or, with the probing depths >5
      mm around the marginal bone were excluded.

      All the participants gave written informed consent to be involved in the clinical trial. The
      study protocol was approved by the Ethical Committee of Biomedical studies, Lithuania
      (Protocol No 111; 10.03.2016; edition No BE-2-27; 20.12.2016).

      Clinical and radiographic examinations:

      All study patients were examined clinically and radiographically at baseline, and in 24
      months (further on, referred as "2 years") after endodontic treatment. The intermediate
      follow-up examinations were set at 12 months' time point, however, only the final study
      results are discussed in the present report.

      The clinical examinations were performed by one examiner (JG) and included standard tests
      such as percussion, palpation, evaluation of coronal seal, of tooth mobility and of the
      periodontal probing depth. All diagnostic procedures were performed in a dental chair using a
      dental mirror and explorer (Dentsply Maillefer, Ballaigues, Switzerland). The case history
      (presence of clinical symptoms, complaints, the time of the previous treatment) was obtained
      from every patient.

      Radiographical examinations of the patients were performed with CBCT imaging, and with
      digital radiography. For the present study purposes, only CBCT data were included in the
      analysis. The baseline CBCT images were already available following the general diagnostic
      and treatment plan. The follow-up CBCT was performed in 2 years after the endodontic
      treatment, only for the respective maxillary or mandibular arch. All images were made with
      i-CAT scanner (Imaging Sciences International Inc., Hatfield, PA, USA), the exposure
      parameters were as follows: 84 kV, 5 mA, 0.3 mm voxel resolution, 6x16 and 6x6 cm field of
      view, 18.3s and 5s acquisition time at baseline and at the final examination, respectively.
      The CBCT images were viewed as an original i-Cat presentation (Apple, Cupertino, CA, USA) on
      the computers with a 27-inch flat panel display with a pixel resolution of 2.560 x 1.440 with
      dimmed ambient light, less than 50 lux, without time restrictions. A total of 256 (128
      baseline and 128 follow up) CBCT images were coded and analyzed by the same examiner (JG),
      without knowledge of the clinical data.

      The radiographical assessment of the periapical status of the teeth was performed following
      the Periapical and Endodontic Status Scale (PESS).
observational model: Cohort
time perspective: Prospective
measure: The positive treatment outcome
time frame: 24 months
description: Decreased periapical radiolucency, with respect to it's size, or/and relation with anatomical structures, location (respective parameters S, R, and D). Moreover, the unchanged mild severity scores S1, D1, and R1 were regarded as positive outcome as well. The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).
measure: The negative treatment outcome
time frame: 24 months
description: Increased/unchanged periapical radiolucency in size, or/and in relation with anatomical structures, or/and in location (respective parameters S, R, and D). By comparing the baseline and the final CBCT images all transition events from the lower to the higher scores and the following unchanged scores were considered as negative treatment outcomes.The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).
arm group label: Clinical observation
description: All study patients were examined by 1 endodontist clinically and radiographically at baseline and after follow up of endodontic treatment.
intervention type: Diagnostic Test
intervention name: Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"
description: Patients were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location.
arm group label: Clinical observation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Lithuanian University of Health Sciences
investigator full name: Jelena Gudac
investigator title: Principal Investigator
mesh term: Periodontitis
mesh term: Periapical Periodontitis
sharing ipd: No