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CompletedNCT00728884PrevailMultiUpdated Sep 8, 2026Results posted

Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible

An observational study in Partial Edentulism, sponsored by ZimVie. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by ZimVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
161
Ages
18 Years and older
Sex
All
01

Study summary

This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance.

Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).

Read the detailed description

This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.

02

Conditions studied

  • Partial Edentulism

Keywords

  • dental implants
  • Certain Prevail
  • multicenter
  • clinical study
  • partial edentulism
  • total edentulism
  • platform switching
  • single stage
  • early loading
  • crestal bone level
  • single tooth replacements
  • short or long fixed bridges
  • overdenture
  • fixed denture
03

In context

Lead sponsor

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

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 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 dental condition specifically:

    1. dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
    2. a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure).
  • 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 visit

Exclusion criteria

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 at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery
  • patients who are pregnant at the screening visit
  • patients with evidence of severe para-functional habits such as bruxing or clenching
  • patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
161 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Osseous Integration

    Time frame: 2 years

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Results

Posted Aug 17, 2009

Participant flow

161 patients were enrolled across all participating centers, with enrollment efforts beginning in September 6 2005 (first patient enrolled) and completing in January 22 2007 (last patient enrolled). Ten participating sites are private practices and two are Universities.

Implant Placement Surgery
Participant flow — Implant Placement Surgery
MilestoneCertain Prevail Implants
Started161
Completed161
Not completed0
Two year post placement follow-up
Participant flow — Two year post placement follow-up
MilestoneCertain Prevail Implants
Started161
Completed49
Not completed112
Withdrew: Lost to follow-up112

Outcome measures

PrimaryOsseous Integration
Time frame:
2 years
Reported as:
Number · participants
Osseous Integration
participantsCertain Prevail Implants
Osseous Integration145

Adverse events

Collected over Adverse event reports are collected from implant placement surgery until final follow up visit, 2 year. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Certain Prevail Implants0/161 (0%)0/161 (0%)7/161 (4.3%)
Most frequent other events
Most frequent other events
EventCertain Prevail Implants
implant failureMusculoskeletal and connective tissue disorders7/161

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Certain Prevail Implants
<=18 years0
Between 18 and 65 years135
>=65 years27
Sex: Female, Male
Sex: Female, Male(Participants)Certain Prevail Implants
Female99
Male63
Region of Enrollment
Region of Enrollment(Participants)Certain Prevail Implants
Austria26
Australia10
Ireland14
United States31
Italy52
France9
Sweden20
08

Study locations

1 site
  • Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde
    Graz, 8036, Austria
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00728884
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Aug 6, 2008
Start date
Sep 6, 2005
Primary completion
Feb 3, 2011
Completion
Jul 7, 2011
Results posted
Aug 17, 2009
Last update
Sep 8, 2026

Study contacts

Martin Lorenzoni, DMD, MD, PhD
principal investigator · MEDIZINISCHE UNIVERSITAT GRAZ

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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