CONDOR Study of Osteonecrosis of the Jaws (TMJ)

June 14, 2011 updated by: Dental Practice-Based Research Network

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440-1309
        • Health Partners Dental Group
      • Minneapolis, Minnesota, United States, 55440-1524
        • Health Partners Research Foundation
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research
      • Portland, Oregon, United States, 97232
        • Permanente Denrtal Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dental Practice-Based Research Network

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)
HealthPartners Institute
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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106037
  • U01DE016747 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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