CONDOR Study of Osteonecrosis of the Jaws (TMJ)

Osteonecrosis of the Jaw Clinical Trial

Official title:

Trans-PBRN Case-control Study of Osteonecrosis of the Jaws

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130389
• Other study ID #: 106037
• Secondary ID: U01DE016747
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: June 14, 2011
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: June 2011
• Source: Dental Practice-Based Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of the Jaw

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Health Partners Dental Group	Minneapolis	Minnesota
United States	Health Partners Research Foundation	Minneapolis	Minnesota
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Permanente Denrtal Associates	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
Dental Practice-Based Research Network	HealthPartners Institute, Kaiser Permanente, National Institute of Dental and Craniofacial Research (NIDCR), Permanente Dental Associates Group, Oregon

Country where clinical trial is conducted

United States,