<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/NCT01670422</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-1233-RV</org_study_id>
    <nct_id>NCT01670422</nct_id>
  </id_info>
  <brief_title>Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ</brief_title>
  <official_title>Risk Factors Associated With Recurrence and Life-threatening Complications for Patients Hospitalized With Chronic Suppurative Osteomyelitis of the Jaw</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China College of Stomatology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China College of Stomatology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinically, recurrence and life-threatening complications are challenging problems for&#xD;
      chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report&#xD;
      about the causes of or risk factors for the two problems. Doctors identify the causes or risk&#xD;
      factors only through clinical experience. The investigators performed a retrospective study&#xD;
      of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors for the&#xD;
      above mentioned two problems were analyzed by logistic regression analysis. The investigators&#xD;
      found that some of the patients' general conditions, including age, admission temperature,&#xD;
      admission white blood cell count, pre-admission antibiotic administration without&#xD;
      consultation, location of the lesion, and general patient condition, were the risk factors.&#xD;
      The results indicate that doctors should be mindful of those risk factors and that the&#xD;
      management should be more aggressive when the above risk factors are present.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective study of 322 patients hospitalized with CSOJ. The socio-demographic&#xD;
      and clinical characteristics were recorded. The risk factors for the above two problems were&#xD;
      analyzed by logistic regression analysis. Frequency and percentage were used to indicate&#xD;
      descriptive research factors. A univariate logistic regression analysis was performed to&#xD;
      calculate the odds ratio (OR) and to identify preliminary risk factors. The preliminary risk&#xD;
      factors were further identified by multivariate logistic regression analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1980</start_date>
  <completion_date type="Actual">May 2009</completion_date>
  <primary_completion_date type="Actual">January 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw</measure>
    <time_frame>30 years</time_frame>
    <description>An age from 6-18 years or &gt; 65 years, pre-admission antibiotic administration, a lesion at the mandibular ramus, concurrent maxillofacial space infection (MSI), and conservation of pathogenic teeth were found to be risk factors for recurrence. An age &gt; 65 years, admission temperature &gt; 39 oC, admission white blood cell (WBC) count &gt;15×109/L, pre-admission antibiotic administration, concurrent MSI, pre-existing diabetes, and respiratory difficulty were found to be risk factors for life-threatening complications.</description>
  </primary_outcome>
  <enrollment type="Actual">322</enrollment>
  <condition>Suppurative Osteomyelitis of Jaw</condition>
  <condition>Potential Abnormality of Glucose Tolerance</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of CSOJ who were admitted to our hospital from 1980 to 2009 were&#xD;
        investigated. Ultimately, 322 patients were enrolled in the study of life-threatening&#xD;
        complications.Patients were divided into four classes according to their age (years): &lt;6,&#xD;
        6-18, 19-65, &gt;65.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnosis on admission was made on the basis of the presence of sequestra and&#xD;
             laminations of periosteal new bone in the pathological area.&#xD;
&#xD;
          -  The other diagnostic criteria is that symptoms such as local pain, pyorrhea, fever,&#xD;
             swelling, fistula, neuropalsy, odontoseisis, lymphadenopathy, bromopnea, and trismus&#xD;
             pain are unresponsive or insensitive to conservative therapy and simple debridement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without confirmed evidence of CSOJ and (or) without standard treatment (a&#xD;
             combination of antimicrobial therapy and surgery consisting of incision and drainage,&#xD;
             debridement or sequestrectomy) were excluded.&#xD;
&#xD;
          -  Paget's disease, hypercementosis, fibrous dysplasia, and early stage malignant bone&#xD;
             tumor were differentially diagnosed and excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>83 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Chen, DMD</last_name>
    <role>Study Chair</role>
    <affiliation>West China Hospital of Stomatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West China Hospital of Stomatology</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China College of Stomatology</investigator_affiliation>
    <investigator_full_name>Lin Chen</investigator_full_name>
    <investigator_title>Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw</investigator_title>
  </responsible_party>
  <keyword>CSOJ</keyword>
  <keyword>recurrence</keyword>
  <keyword>life-threatening complications</keyword>
  <keyword>risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Suppuration</mesh_term>
    <mesh_term>Recurrence</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/NCT01670422
org study id: ABT-1233-RV
nct id: NCT01670422
lead sponsor: 
has dmc: No
Clinically, recurrence and life-threatening complications are challenging problems for
      chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report
      about the causes of or risk factors for the two problems. Doctors identify the causes or risk
      factors only through clinical experience. The investigators performed a retrospective study
      of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors for the
      above mentioned two problems were analyzed by logistic regression analysis. The investigators
      found that some of the patients' general conditions, including age, admission temperature,
      admission white blood cell count, pre-admission antibiotic administration without
      consultation, location of the lesion, and general patient condition, were the risk factors.
      The results indicate that doctors should be mindful of those risk factors and that the
      management should be more aggressive when the above risk factors are present.
This is a retrospective study of 322 patients hospitalized with CSOJ. The socio-demographic
      and clinical characteristics were recorded. The risk factors for the above two problems were
      analyzed by logistic regression analysis. Frequency and percentage were used to indicate
      descriptive research factors. A univariate logistic regression analysis was performed to
      calculate the odds ratio (OR) and to identify preliminary risk factors. The preliminary risk
      factors were further identified by multivariate logistic regression analysis.
observational model: Case-Control
time perspective: Retrospective
measure: Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw
time frame: 30 years
description: An age from 6-18 years or > 65 years, pre-admission antibiotic administration, a lesion at the mandibular ramus, concurrent maxillofacial space infection (MSI), and conservation of pathogenic teeth were found to be risk factors for recurrence. An age > 65 years, admission temperature > 39 oC, admission white blood cell (WBC) count >15×109/L, pre-admission antibiotic administration, concurrent MSI, pre-existing diabetes, and respiratory difficulty were found to be risk factors for life-threatening complications.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 83 Years
healthy volunteers: No
last name: Lin Chen, DMD
role: Study Chair
affiliation: West China Hospital of Stomatology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China College of Stomatology
investigator full name: Lin Chen
investigator title: Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw
mesh term: Osteomyelitis
mesh term: Suppuration
mesh term: Recurrence