Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lin Chen, West China College of Stomatology
ClinicalTrials.gov Identifier:
NCT01670422
First received: July 31, 2012
Last updated: August 21, 2012
Last verified: August 2012

July 31, 2012
August 21, 2012
January 1980
January 2009   (final data collection date for primary outcome measure)
Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw [ Time Frame: 30 years ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01670422 on ClinicalTrials.gov Archive Site
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Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ
Risk Factors Associated With Recurrence and Life-threatening Complications for Patients Hospitalized With Chronic Suppurative Osteomyelitis of the Jaw

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
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

Patients with a diagnosis of CSOJ who were admitted to our hospital from 1980 to 2009 were investigated. Ultimately, 322 patients were enrolled in the study of life-threatening complications.Patients were divided into four classes according to their age (years): <6, 6-18, 19-65, >65.

  • Suppurative Osteomyelitis of Jaw
  • Potential Abnormality of Glucose Tolerance
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Chen L, Li T, Jing W, Tang W, Tian W, Li C, Liu L. Risk factors of recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw. BMC Infect Dis. 2013 Jul 11;13:313. doi: 10.1186/1471-2334-13-313.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
May 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The diagnosis on admission was made on the basis of the presence of sequestra and laminations of periosteal new bone in the pathological area.
  • The other diagnostic criteria is that symptoms such as local pain, pyorrhea, fever, swelling, fistula, neuropalsy, odontoseisis, lymphadenopathy, bromopnea, and trismus pain are unresponsive or insensitive to conservative therapy and simple debridement.

Exclusion Criteria:

  • Patients without confirmed evidence of CSOJ and (or) without standard treatment (a combination of antimicrobial therapy and surgery consisting of incision and drainage, debridement or sequestrectomy) were excluded.
  • Paget's disease, hypercementosis, fibrous dysplasia, and early stage malignant bone tumor were differentially diagnosed and excluded.
Both
1 Month to 83 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01670422
ABT-1233-RV
No
Lin Chen, West China College of Stomatology
West China College of Stomatology
Not Provided
Study Chair: Lin Chen, DMD West China Hospital of Stomatology
West China College of Stomatology
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP