NCT01670422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1980

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1980

Completed
29 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

29 years

First QC Date

July 31, 2012

Last Update Submit

August 21, 2012

Conditions

Keywords

CSOJrecurrencelife-threatening complicationsrisk factors

Outcome Measures

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.

    30 years

Eligibility Criteria

Age1 Month - 83 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Stomatology

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lin Chen, DMD

    West China Hospital of Stomatology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 22, 2012

Study Start

January 1, 1980

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations