CONDOR Study of Osteonecrosis of the Jaws (TMJ)

NCT ID: NCT01130389

Last Updated: 2011-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-09-30

Brief Summary

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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

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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

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Osteonecrosis of the Jaw

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Permanente Dental Associates Group, Oregon

OTHER

Sponsor Role collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Dental Practice-Based Research Network

NETWORK

Sponsor Role lead

Responsible Party

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University of Alabama at Birmingham

Principal Investigators

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Gregg H. Gilbert, DDS, MBA

Role: STUDY_CHAIR

Dental Practice-Based Research Network (DPBRN)

Andrei Barasch, DMD, MDSc

Role: PRINCIPAL_INVESTIGATOR

Dental Practice-Based Research Network (DPBRN)

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Health Partners Dental Group

Minneapolis, Minnesota, United States

Site Status

Health Partners Research Foundation

Minneapolis, Minnesota, United States

Site Status

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Site Status

Permanente Denrtal Associates

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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U01DE016747

Identifier Type: NIH

Identifier Source: secondary_id

View Link

106037

Identifier Type: -

Identifier Source: org_study_id

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