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CompletedNCT01670422Updated Aug 22, 2012

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

An observational study in Suppurative Osteomyelitis of Jaw and Potential Abnormality of Glucose Tolerance, sponsored by West China College of Stomatology. Completed at 1 site in China. Open to participants aged 1 Month to 83 Years. Per ClinicalTrials.gov, last updated 2012-08-22.

Primary conditionnone(registry's first term: Recurrence)No conditionIs this wrong?Recurrence describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by West China College of Stomatology · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
322
Ages
1 Month to 83 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Suppurative Osteomyelitis of Jaw
  • Potential Abnormality of Glucose Tolerance

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Keywords

  • CSOJ
  • recurrence
  • life-threatening complications
  • risk factors
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In context

Lead sponsor

West China College of Stomatology is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 83 Years
Sexes eligible
All
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.

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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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
322 participants (actual)
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 years

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Study locations

1 site
  • West China Hospital of Stomatology
    Chengdu, Sichuan 610041, China
08

References and documents

Publications

  • 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. PubMed 23844897 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 1980, a primary completion of Jan 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2012
First posted
Aug 22, 2012
Start
Jan 1980
Primary completionActual
Jan 2009
CompletionActual
May 2009
Last update
Aug 22, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01670422
Lead sponsor
West China College of Stomatology
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) — Principal investigator
First posted
Aug 22, 2012
Start date
Jan 1980
Primary completion
Jan 2009
Completion
May 2009
Last update
Aug 22, 2012

Study contacts

Lin Chen, DMD
study chair · West China Hospital of Stomatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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