A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases. (Cliffhanger)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biomet, Inc.

ClinicalTrials.gov Identifier:

NCT00728754

First received: August 1, 2008

Last updated: November 6, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 1, 2008

Last Updated Date

November 6, 2012

Start Date ^ICMJE

March 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.

Original Primary Outcome Measures ^ICMJE

crestal bone regression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00728754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Osseous Integration [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Osseous integration [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.

Official Title ^ICMJE

A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone

Brief Summary

This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version of the implant.

Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for a similar but non-lateralized Osseotite Certain implant.

Detailed Description

This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Partial Edentulism
Tooth Disease

Intervention ^ICMJE

Device: Dental implant Osseotite Prevail
Root form titanium dental implant
Other Names:
- Osseotite
- Prevail
Device: Dental implant Osseotite
root form titanium dental implant

Other Name: Osseotite

Study Arm (s)

Experimental: Dental implant Osseotite Prevail
Dental implant with lateralized design

Intervention: Device: Dental implant Osseotite Prevail
Active Comparator: Dental implant Osseotite
Dental implant without the lateralized design

Intervention: Device: Dental implant Osseotite

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients of either sex and any race greater than 18 years of age
patients for whom a decision has already been made to use dental implants for treating an existing condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers allowed but one interior crown may be a pontic
patients must be physically able to tolerate conventional surgical and restorative procedures
patients must agree to be evaluated for each study visit, especially the yearly follow-up visits

Exclusion Criteria:

patients with active infection or severe inflammation in the areas intended for implant placement
patients with a >10 cigarette per day smoking habit
patients with uncontrolled diabetes mellitus
patients with metabolic bone disease
patients who have had treatment with therapeutic radiation to the head within the past 12 months
patients in need of allogenic bone grafting a the site of the intended study implant
patients who are pregnant at the screening visit
patients with evidence of severe para-functional habits such as bruxing or clenching
patients with cantilevers and more than one pontic per bridge

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00728754

Other Study ID Numbers ^ICMJE

2301

Has Data Monitoring Committee

Yes

Responsible Party

Biomet, Inc.

Study Sponsor ^ICMJE

Biomet, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Harold Baumgarten, DMD

University of Pennsylvania

Information Provided By

Biomet, Inc.

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top