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: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Partial Edentulism
Tooth Disease
Device: Dental implant Osseotite Prevail
Device: Dental implant Osseotite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Osseous Integration [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: March 2005
Study Completion Date: April 2011
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dental implant Osseotite Prevail
Dental implant with lateralized design
Device: Dental implant Osseotite Prevail
Root form titanium dental implant
Other Names:
  • Osseotite
  • Prevail
Active Comparator: Dental implant Osseotite
Dental implant without the lateralized design
Device: Dental implant Osseotite
root form titanium dental implant
Other Name: Osseotite

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728754

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Harold Baumgarten, DMD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00728754     History of Changes
Other Study ID Numbers: 2301
Study First Received: August 1, 2008
Results First Received: June 26, 2009
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 16, 2014