CONDOR Study of Osteonecrosis of the Jaws (TMJ)
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Purpose
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.
| Condition |
|---|
|
Osteonecrosis of the Jaw |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Trans-PBRN Case-control Study of Osteonecrosis of the Jaws |
| Enrollment: | 309 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT).
Exclusion Criteria:
- participants with a history of sickle cell anemia
- participants with a history of external severe trauma to the jaws
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Minnesota | |
| Health Partners Dental Group | |
| Minneapolis, Minnesota, United States, 55440-1309 | |
| Health Partners Research Foundation | |
| Minneapolis, Minnesota, United States, 55440-1524 | |
| United States, Oregon | |
| Kaiser Permanente Center for Health Research | |
| Portland, Oregon, United States, 97227 | |
| Permanente Denrtal Associates | |
| Portland, Oregon, United States, 97232 | |
| Study Chair: | Gregg H. Gilbert, DDS, MBA | Dental Practice-Based Research Network (DPBRN) |
| Principal Investigator: | Andrei Barasch, DMD, MDSc | Dental Practice-Based Research Network (DPBRN) |
More Information
No publications provided
| Responsible Party: | Gregg H. Gilbert, DDS, MBA, Study Chair, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01130389 History of Changes |
| Other Study ID Numbers: | 106037, U01DE016747 |
| Study First Received: | May 24, 2010 |
| Last Updated: | June 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dental Practice-Based Research Network:
|
ONJ |
Additional relevant MeSH terms:
|
Osteonecrosis Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013