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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
History of Changes
  Purpose

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.


Condition
Suppurative Osteomyelitis of Jaw
Potential Abnormality of Glucose Tolerance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Risk Factors Associated With Recurrence and Life-threatening Complications for Patients Hospitalized With Chronic Suppurative Osteomyelitis of the Jaw

Further study details as provided by West China College of Stomatology:

Primary Outcome Measures:
  • 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.


Enrollment: 322
Study Start Date: January 1980
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Month to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670422

Locations
China, Sichuan
West China Hospital of Stomatology
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China College of Stomatology
Investigators
Study Chair: Lin Chen, DMD West China Hospital of Stomatology
  More Information

No publications provided

Responsible Party: Lin Chen, Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw, West China College of Stomatology
ClinicalTrials.gov Identifier: NCT01670422     History of Changes
Other Study ID Numbers: ABT-1233-RV
Study First Received: July 31, 2012
Last Updated: August 21, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by West China College of Stomatology:
CSOJ
recurrence
life-threatening complications
risk factors

Additional relevant MeSH terms:
Congenital Abnormalities
Osteomyelitis
Recurrence
Suppuration
Bone Diseases, Infectious
Infection
 Bone Diseases
Musculoskeletal Diseases
Disease Attributes
Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on June 17, 2013