<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/NCT03227172</url>
  </required_header>
  <id_info>
    <org_study_id>15034</org_study_id>
    <nct_id>NCT03227172</nct_id>
  </id_info>
  <brief_title>Differential Diagnosis Between Granuloma and Radicular Cyst: Effectiveness of Magnetic Resonance Imaging.</brief_title>
  <official_title>The Accuracy of Magnetic Resonance Imaging in Diagnosing Endodontic Periapical Lesion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</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 radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were&#xD;
      investigated by two radiologists using MRI, based on the same six criteria, to categorize the&#xD;
      lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded&#xD;
      to the radiologist's diagnoses) analyzed all specimens by referring to seven specific&#xD;
      parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater&#xD;
      agreements between the radiologists and pathologists in terms of MRI and histological&#xD;
      diagnoses, respectively, along with the discriminant power of the adopted criteria and the&#xD;
      accuracy of the MRI assessments compared with the histopathologic results, were calculated.&#xD;
&#xD;
      A strong inter-rater reliability was observed between the two radiologists (k-statistic =&#xD;
      0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was&#xD;
      higher for the radiological (Guttmann's lambda lower bound &gt; 0.6) than histopathological&#xD;
      criteria. The accuracy (true positives plus true negatives) of the radiologists was higher&#xD;
      than that of the pathologists based on receiver operator characteristic analysis (area under&#xD;
      the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and&#xD;
      comparable to histopathological reliability, highlighting the usefulness of this non-invasive&#xD;
      exam as a pre-treatment diagnostic method for periapical endodontic lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">December 20, 2016</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis</measure>
    <time_frame>5 years</time_frame>
    <description>To determine the diagnostic accuracy of the radiologists compared with the pathologists (considered the gold standard), receiver operator characteristic (ROC) analysis was performed assuming that the diagnostic test is dichotomous. This method for computing the area under curve (AUC) and its error is in agreement with fitting procedures used for diagnostic tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inter-pathologist diagnoses , inter-radiologist diagnoses and internal consistency of the items used for the differential diagnosis by radiologists and pathologists.</measure>
    <time_frame>5 years</time_frame>
    <description>To examine inter-rater agreement between the two radiologists and two pathologists, we calculated Cohen's kappa.&#xD;
The sensitivity and specificity were determined to assess the ability of MRI to differentially diagnose cysts and granulomas. Sensitivity was calculated as the proportion of true-positive test results (cyst diagnosed consistently by both MRI and biopsy) among the patients with the &quot;disease&quot; (cyst diagnosed by biopsy). Specificity was calculated as the proportion of true-negative results (granuloma diagnosed consistently by both MRI and biopsy) among the &quot;disease-free&quot; subjects (granuloma diagnosed by biopsy) .&#xD;
Guttman's lambda coefficient was computed to account for the reliability of the used criteria.</description>
  </secondary_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>Periapical Diseases</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>apicoectomy</intervention_name>
    <description>After flap elevation and osteotomy , peri-apical lesion and the root tip were located: after root-end resection using a fissure bur, the resected root tip and the pathological tissue were removed and immediately preserved in 1% formaldehyde solution.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        34 patients (17 males and 17 females; mean age 41.9 (range 21-76) years) with periapical&#xD;
        endodontic lesions diagnosed by clinical and radiological examination using 2D standard&#xD;
        x-rays (periapical and panoramic x-rays) or multislice CT/CBCT in the Oral and&#xD;
        Maxillofacial Unit of the University of Bologna between January 2011 and December 2015, and&#xD;
        treated with enucleation of the lesion and apicoectomy after a pre-operative MRI exam were&#xD;
        retrospectively enrolled in this study. The chart of these patients, that underwent a&#xD;
        traditional and standard therapeutic protocol, the radiological imaging and the&#xD;
        histopathological data, were analysed after the treatment by a team of two radiologists and&#xD;
        two pathologists.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient age ≥ 18 years&#xD;
&#xD;
          -  the diameter of the lesion ≥ 5 mm, assessed based on periapical x-ray,&#xD;
&#xD;
          -  an acceptable endodontic treatment for the involved tooth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  general medical contraindications for classification of the patient as level III or&#xD;
             higher according to the American Society of Anesthesiologists,&#xD;
&#xD;
          -  teeth involved in the lesion, the function of which could not be salvaged after&#xD;
             enucleation of the lesion and apicoectomy. The radiological exclusion criteria were&#xD;
&#xD;
          -  contraindication undergoing magnetic resonance: presence of a pacemaker or any&#xD;
             metallic devices that could interfere with the magnetic field;&#xD;
&#xD;
          -  severe claustrophobia,&#xD;
&#xD;
          -  weight ≥ 130 kg&#xD;
&#xD;
          -  intolerance to gadolinium-DTPA as a contrast agent;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Giuseppe Lizio</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periapical Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03227172
org study id: 15034
nct id: NCT03227172
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were
      investigated by two radiologists using MRI, based on the same six criteria, to categorize the
      lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded
      to the radiologist's diagnoses) analyzed all specimens by referring to seven specific
      parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater
      agreements between the radiologists and pathologists in terms of MRI and histological
      diagnoses, respectively, along with the discriminant power of the adopted criteria and the
      accuracy of the MRI assessments compared with the histopathologic results, were calculated.

      A strong inter-rater reliability was observed between the two radiologists (k-statistic =
      0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was
      higher for the radiological (Guttmann's lambda lower bound > 0.6) than histopathological
      criteria. The accuracy (true positives plus true negatives) of the radiologists was higher
      than that of the pathologists based on receiver operator characteristic analysis (area under
      the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and
      comparable to histopathological reliability, highlighting the usefulness of this non-invasive
      exam as a pre-treatment diagnostic method for periapical endodontic lesions.
observational model: Cohort
time perspective: Retrospective
measure: The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis
time frame: 5 years
description: To determine the diagnostic accuracy of the radiologists compared with the pathologists (considered the gold standard), receiver operator characteristic (ROC) analysis was performed assuming that the diagnostic test is dichotomous. This method for computing the area under curve (AUC) and its error is in agreement with fitting procedures used for diagnostic tests.
measure: inter-pathologist diagnoses , inter-radiologist diagnoses and internal consistency of the items used for the differential diagnosis by radiologists and pathologists.
time frame: 5 years
description: To examine inter-rater agreement between the two radiologists and two pathologists, we calculated Cohen's kappa.
The sensitivity and specificity were determined to assess the ability of MRI to differentially diagnose cysts and granulomas. Sensitivity was calculated as the proportion of true-positive test results (cyst diagnosed consistently by both MRI and biopsy) among the patients with the "disease" (cyst diagnosed by biopsy). Specificity was calculated as the proportion of true-negative results (granuloma diagnosed consistently by both MRI and biopsy) among the "disease-free" subjects (granuloma diagnosed by biopsy) .
Guttman's lambda coefficient was computed to account for the reliability of the used criteria.
intervention type: Procedure
intervention name: apicoectomy
description: After flap elevation and osteotomy , peri-apical lesion and the root tip were located: after root-end resection using a fissure bur, the resected root tip and the pathological tissue were removed and immediately preserved in 1% formaldehyde solution.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Giuseppe Lizio
investigator title: research assistant
mesh term: Periapical Diseases
sharing ipd: Undecided