- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670422
Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ
August 21, 2012 updated by: Lin Chen, West China College of Stomatology
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
322
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital of Stomatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 83 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw
Time Frame: 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.
|
30 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Lin Chen, DMD, West China Hospital of Stomatology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1980
Primary Completion (ACTUAL)
January 1, 2009
Study Completion (ACTUAL)
May 1, 2009
Study Registration Dates
First Submitted
July 31, 2012
First Submitted That Met QC Criteria
August 21, 2012
First Posted (ESTIMATE)
August 22, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 22, 2012
Last Update Submitted That Met QC Criteria
August 21, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABT-1233-RV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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