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

Potential Abnormality of Glucose Tolerance Clinical Trial

Official title:

Risk Factors Associated With Recurrence and Life-threatening Complications for Patients Hospitalized With Chronic Suppurative Osteomyelitis of the Jaw

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670422
• Other study ID #: ABT-1233-RV
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: August 21, 2012
• Start date: January 1980
• Est. completion date: May 2009

Study information

• Verified date: August 2012
• Source: West China College of Stomatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: May 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 83 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteomyelitis
• Potential Abnormality of Glucose Tolerance
• Recurrence
• Suppurative Osteomyelitis of Jaw

Locations

Country	Name	City	State
China	West China Hospital of Stomatology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China College of Stomatology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw	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.	30 years	Yes