NCT01130389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

May 24, 2010

Last Update Submit

June 14, 2011

Conditions

Osteonecrosis of the Jaw

Keywords

ONJ

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT).

You may not qualify if:

  • participants with a history of sickle cell anemia
  • participants with a history of external severe trauma to the jaws

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Health Partners Dental Group

Minneapolis, Minnesota, 55440-1309, United States

Location

Health Partners Research Foundation

Minneapolis, Minnesota, 55440-1524, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Permanente Denrtal Associates

Portland, Oregon, 97232, United States

Location

Study Officials

  • Gregg H. Gilbert, DDS, MBA

    Dental Practice-Based Research Network (DPBRN)

    STUDY CHAIR

  • Andrei Barasch, DMD, MDSc

    Dental Practice-Based Research Network (DPBRN)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

US(5)