Suppurative Osteomyelitis of JawNCT01670422
Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ
An observational study of Suppurative Osteomyelitis of Jaw and Potential Abnormality of Glucose Tolerance, run by West China College of Stomatology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 month to 83 years
- Conditions the study is for
- Suppurative Osteomyelitis of Jaw, Potential Abnormality of Glucose Tolerance
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- Jan 1980to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 83 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Keywords
- CSOJ, recurrence, life-threatening complications, risk factors
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 1980
- Primary completionJan 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suppurative Osteomyelitis of JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China College of Stomatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, West China College of Stomatology
- Investigators
- Lin Chen, DMD, Study chair, West China Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670422
- Sponsor's protocol ID
- ABT-1233-RV
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With Recurrence and Life-threatening Complications for Patients Hospitalized With Chronic Suppurative Osteomyelitis of the Jaw
- ClinicalTrials.gov ID
- NCT01670422
- Acronym / sponsor ID
- ABT-1233-RV
- Keywords
- CSOJ, recurrence, life-threatening complications, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- West China College of StomatologyUniversity, hospital or other
- Study start
- Jan 1980
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- Derived from this study: PubMed 23844897Chen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chen, DMD study chair
West China Hospital of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suppurative Osteomyelitis of Jaw and Potential Abnormality of Glucose Tolerance, run by West China College of Stomatology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors associated with recurrence and life-threatening complications for patients hospitalized with chronic suppurative osteomyelitis of the jaw (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.