A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases - Full Text View

Sponsored by:	Biomet 3i, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00723944

Purpose

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design 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 similar but non-lateralized Osseotite Certain implants.

Condition	Intervention
Edentulism Dental Implants	Device: Dental implants Osseotite Prevail Device: Placebo dental implant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized-Controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-Span Fixed Bridge Cases for Preservation of Crestal Bone

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

crestal bone and periodontal outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Osseous integration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	February 2005
Estimated Study Completion Date:	September 2009
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dental implant with lateralized design	Device: Dental implants Osseotite Prevail Root form titanium dental implant
2: Placebo Comparator Dental implant without the lateralized design	Device: Placebo dental implant Dental implant without the lateralized design

Detailed Description:

This is a prospective, randomized-controlled study where patients with qualifying partial edentulism will receive a short fixed bridge restoration. Each implant site will be randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants are placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment will continue until 10 patients are treated at each participating study center.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are 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 visit

Exclusion Criteria:

patients with active infection or severe inflammation in the areas intended for the implants
patients with more than 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 at 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723944

Locations

Germany
Charite- Universitatsmedizin Berlin
Berlin, Germany, D-10117

Sponsors and Collaborators

Biomet 3i, LLC

Investigators

Principal Investigator:

Anton Friedmann, DMD

Charite- Zentrum fur Zahnmedizin

More Information

No publications provided

Responsible Party:	Biomet 3i, Inc. ( Jim Kenealy, Pharm.D.; Director Clinical Research )
Study ID Numbers:	2302
Study First Received:	July 25, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00723944 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biomet, Inc.:

dental implants
Osseotite Certain Prevail
Lateralized
non-lateralized
Osseotite Certain
multicenter
randomized

clinical study
partial edentulism
single stage
early loading
crestal bone level
short fixed bridge

ClinicalTrials.gov processed this record on May 07, 2009