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CompletedNCT00728962FireballUpdated Jul 28, 2026Results posted

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

An observational study in Partial Edentulism and Tooth Disease, sponsored by ZimVie. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by ZimVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Partial Edentulism
  • Tooth Disease

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Keywords

  • dental implants
  • Osseotite Certain Prevail
  • multicenter
  • observational
  • clinical study
  • partial edentulism
  • single stage
  • immediate occlusal loading
  • crestal bone level
  • short fixed bridge
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's enrollment of 75 is below the median of 224 across 16 observational studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)
06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. Crestal Bone Regression

    Time frame: four years

07

Results

Posted Feb 5, 2010

Participant flow

Each site endeavored to enroll a maximum of 15 patients, with enrollment efforts beginning in March 2005. Enrollment period remained open at all sites until April 2006. Three participating sites are Universities and four are private practices.

Implant Placement Surgery
Participant flow — Implant Placement Surgery
MilestoneOsseotite Certain Prevail Implant
Started75
Completed65
Not completed10
Withdrew: Adverse event8
Withdrew: Lost to follow-up1
Withdrew: Protocol violation1
Permanent Prosthesis Placement
Participant flow — Permanent Prosthesis Placement
MilestoneOsseotite Certain Prevail Implant
Started65
Completed62
Not completed3
Withdrew: Adverse event3
One Year post placement follow-up
Participant flow — One Year post placement follow-up
MilestoneOsseotite Certain Prevail Implant
Started62
Completed62
Not completed0
Two Year post placement follow-up
Participant flow — Two Year post placement follow-up
MilestoneOsseotite Certain Prevail Implant
Started62
Completed59
Not completed3
Withdrew: Lost to follow-up3

Outcome measures

PrimaryPatients 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.

Time frame:
1 year
Reported as:
Number · participants
Patients With Implants Achieving Osseous Integration
participantsOsseotite Certain Prevail Implant
Patients With Implants Achieving Osseous Integration59
SecondaryCrestal Bone Regression
Time frame:
four years

Results for this outcome have not been posted.

Adverse events

Collected over Adverse event reports are collected from day 1 to present; 4 years of study duration to date.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Osseotite Certain Prevail Implant—0/75 (0%)11/75 (14.7%)
Most frequent other events
Most frequent other events
EventOsseotite Certain Prevail Implant
Loss of integration of implantSurgical and medical procedures11/75

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Osseotite Certain Prevail Implant
<=18 years0
Between 18 and 65 years62
>=65 years13
Sex: Female, Male
Sex: Female, Male(Participants)Osseotite Certain Prevail Implant
Female36
Male39
Region of Enrollment
Region of Enrollment(participants)Osseotite Certain Prevail Implant
United States22
Italy17
Netherlands7
France16
Germany13
08

Study locations

1 site
  • University of Southern California
    Los Angeles, California 90089, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2005, a primary completion of May 2006 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2010, 3 years 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2008
First posted
Aug 6, 2008
Start
Mar 2005
Primary completionActual
May 2006
CompletionActual
Oct 2009
Results first posted
Feb 5, 2010
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00728962
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Aug 6, 2008
Start date
Mar 2005
Primary completion
May 2006
Completion
Oct 2009
Results posted
Feb 5, 2010
Last update
Jul 28, 2026

Study contacts

Hessam Nowzari, DDS
principal investigator · University of Southern California

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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