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

A Prospective, Observational Study of Osseotite Certain IOL (Immediate Occlusal Loading) Implants in Immediate Occlusal Loading of Short Span Fixed Restorations

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Tooth Disease

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With Implants Achieving Osseous Integration	Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Crestal Bone Regression	four years

Collaborators and Investigators

• Sponsor: ZimVie
• Investigators: Principal Investigator: Hessam Nowzari, DDS, University of Southern California

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 1, 2008
• First Submitted That Met QC Criteria: August 5, 2008
• First Posted (Estimate): August 6, 2008

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: multicenter; dental implants; observational; clinical study; crestal bone level; partial edentulism; short fixed bridge; Osseotite Certain Prevail; single stage; immediate occlusal loading
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: 2208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO