CONDOR Study of Osteonecrosis of the Jaws (TMJ)

This study has been completed.
Sponsor:
Collaborators:
HealthPartners Institute for Education and Research
Kaiser Permanente
Permanente Dental Associates Group, Oregon
Information provided by:
Dental Practice-Based Research Network
ClinicalTrials.gov Identifier:
NCT01130389
First received: May 24, 2010
Last updated: June 14, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Dental Practice-Based Research Network:

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)
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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130389

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
Sponsors and Collaborators
Dental Practice-Based Research Network
HealthPartners Institute for Education and Research
Kaiser Permanente
Permanente Dental Associates Group, Oregon
Investigators
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 September 18, 2014