NCT00728962

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 5, 2010

Completed
Last Updated

April 19, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

August 1, 2008

Results QC Date

June 26, 2009

Last Update Submit

March 24, 2022

Conditions

Partial EdentulismTooth Disease

Keywords

dental implantsOsseotite Certain Prevailmulticenterobservationalclinical studypartial edentulismsingle stageimmediate occlusal loadingcrestal bone levelshort fixed bridge

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Crestal Bone Regression

    four years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Results Point of Contact

Title
Clinical Research Manager
Organization
Biomet 3i LLC
cristina.matthews@biomet.com
5617766722

Study Officials

  • Hessam Nowzari, DDS

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

March 1, 2005

Primary Completion

May 1, 2006

Study Completion

October 1, 2009

Last Updated

April 19, 2022

Results First Posted

February 5, 2010

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)