Osteonecrosis of the JawNCT01130389
CONDOR Study of Osteonecrosis of the Jaws (TMJ)
An observational study of Osteonecrosis of the Jaw, run by Dental Practice-Based Research Network at 5 sites in United States.
Trial summary
The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ), including the possible association with bisphosphonates (BPs). This study used the research infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN, PEARL, PRECEDENT). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteonecrosis of the Jaw
- How many people
- 309 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2007to Sep 2008
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The human subjects involved in this study were patients of dentists from the dental practice-based research networks (DPBRN, PEARL, PRECEDENT) who identified (ONJ) cases and chose to particpate in the study.
Who may be able to join
- participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT).
Who cannot join
- participants with a history of sickle cell anemia
- participants with a history of external severe trauma to the jaws
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Health Partners Dental Group
Minneapolis, Minnesota, 55440-1309
Health Partners Research Foundation
Minneapolis, Minnesota, 55440-1524
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Permanente Denrtal Associates
Portland, Oregon, 97232
About this study
Official title: Trans-PBRN Case-control Study of Osteonecrosis of the Jaws
The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ), including the possible association with bisphosphonates (BPs). This study used the research infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN, PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for analysis.
Read the detailed description
The aims of this study were to (1) test the hypothesis that (BP) treatment is a risk factor for (ONJ); (2) to test the hypothesis that dental diseases (particularly periodontal disease), and invasive dental procedures such as dental extractions are true risk factors for (ONJ).
- Conditions
- Osteonecrosis of the Jaw
- Keywords
- ONJ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis of the 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
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Gregg H. Gilbert, DDS, MBA, Study chair, Dental Practice-Based Research Network (DPBRN)Andrei Barasch, DMD, MDSc, Principal investigator, Dental Practice-Based Research Network (DPBRN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130389
- Sponsor's protocol ID
- 106037
- Other IDs
- U01DE016747
- Status last verified
- Jun 2011
- First submitted
- 24 May 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-PBRN Case-control Study of Osteonecrosis of the Jaws
- ClinicalTrials.gov ID
- NCT01130389
- Acronym / sponsor ID
- 106037
- Conditions
- Osteonecrosis of the Jaw
- Keywords
- ONJ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 May 2010 (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.
The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ), including the possible association with bisphosphonates (BPs). This study used the research infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN, PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for analysis.
Detailed description
The aims of this study were to (1) test the hypothesis that (BP) treatment is a risk factor for (ONJ); (2) to test the hypothesis that dental diseases (particularly periodontal disease), and invasive dental procedures such as dental extractions are true risk factors for (ONJ).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The human subjects involved in this study were patients of dentists from the dental practice-based research networks (DPBRN, PEARL, PRECEDENT) who identified (ONJ) cases and chose to particpate in the study.
Key inclusion criteria (1 listed)
- participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT).
Key exclusion criteria (2 listed)
- participants with a history of sickle cell anemia
- participants with a history of external severe trauma to the jaws
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
Not reported in the source record.
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 16 Jun 2011.
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Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
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Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
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Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
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.
Gregg H. Gilbert, DDS, MBA study chair
Dental Practice-Based Research Network (DPBRN)
Andrei Barasch, DMD, MDSc principal investigator
Dental Practice-Based Research Network (DPBRN)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis of the Jaw, run by Dental Practice-Based Research Network at 5 sites in United States.
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 1 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 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
Where can I read the original study information?
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 16 Jun 2011.