A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading. (Fireball)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00728962
First received: August 1, 2008
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

This prospective, multicenter study evaluates the performance of the Osseotite Prevail implant when to support a short fixed bridge with immediate occlusal loading, providing the patient with the use of a temporary prosthesis until the final prosthesis is made.

Study (null) hypothesis: This is an observational study in which no concurrent control group will be observed. Results of the study will be compared with the performance of other Osseotite implants from published Osseotite multicenter studies.


Condition
Partial Edentulism
Tooth Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study of Osseotite Certain IOL Implants in Immediate Occlusal Loading of Short Span Fixed Restorations

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Patients With Implants Achieving Osseous Integration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.


Secondary Outcome Measures:
  • Crestal Bone Regression [ Time Frame: four years ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: March 2005
Study Completion Date: October 2009
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, observational study in which all the patients will have implants placed and a provisional prosthesis attached within 24 hours of implant surgery. Each restorative case will consist of a posterior short span fixed bridge of four implants or less. The final prosthesis will be placed within five months or implant placement surgery. Overall success will be determined on the basis of procedural success, prosthesis success, and implant success.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

These will be patients who are otherwise seeking dental implant therapy and belong to the study centers' standard patient population.

Criteria

Inclusion Criteria:

  • patients of either sex and of any race, 18 years of age or older
  • patients for whom the decision has already been made to use dental implants for treating partial edentulism in the posterior mandible or maxilla using a short span fixed prosthesis of two to four units
  • patients must be physically able to tolerate conventional surgical and restorative procedures
  • requirements for implant placement include: at least 1mm bone will be available at the buccal and lingual aspect of the implant and at least 1mm of bone below the apex
  • patients must agree to return to the clinic for each study follow-up visit
  • requirements for prosthetic fabrication include: bone width at least 6mm and a bone height of at least 11mm

Exclusion Criteria:

  • patients with active infection or severe inflammation in the areas intended for implant placement
  • patients with a >10 cigarettes / day smoking habit
  • patients with uncontrolled diabetes or metabolic bone disease
  • patients with a history of therapeutic radiation to the head
  • patients in need of bone grafting at the site of the intended study implant; if at the time of surgery some lateral voids need to be filled this is acceptable and does not exclude the patient from the analysis
  • patients who are known to be pregnant
  • patients with para-functional habits with evidence of severe bruxing or clenching
  • placement of implants into sites with less than sixteen weeks of post-extraction healing; for 3-4 unit cases one implant site may have less than sixteen weeks of healing prior to implant placement
  • type III or IV bone characteristics of the intended implant sites
  • inter-arch distance of less than 7mm (planned location of implant seating platform to the apposing occlusal landmark)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728962

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Hessam Nowzari, DDS University of Southern California
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00728962     History of Changes
Other Study ID Numbers: 2208
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
multicenter
observational
clinical study
partial edentulism
single stage
immediate occlusal loading
crestal bone level
short fixed bridge

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 27, 2014