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

Completed

• Conditions: Suppurative Osteomyelitis of Jaw; Potential Abnormality of Glucose Tolerance

• Registration Number: NCT01670422
• Lead Sponsor: West China College of Stomatology

Brief Summary

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.

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.

Study Timeline

• Primary Completion: 2009-01
• Study Completion: 2009-05
• Study First Submitted: 2012-07-31
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw	30 years	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.

Trial Locations

Locations (1)

West China Hospital of Stomatology; 🇨🇳 Chengdu, Sichuan, China