Partial EdentulismPrevailMultiNCT00728884

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

An observational study of Partial Edentulism, run by ZimVie at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Partial Edentulism
How many people: 161 participants
Where: 1 siteAustria
Study dates: 6 Sep 2005to 7 Jul 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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:
dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde
Graz, 8036

Other trials in Austria

About this study

Official title: Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions

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.

Conditions: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Osseous Integration
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 20057 Jul 2011

First posted6 Aug 2008 (estimated)
Study start6 Sep 2005
Primary completion3 Feb 2011
Study completion7 Jul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Partial EdentulismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00728884
Sponsor's protocol ID: 2406
Acronym: PrevailMulti
Status last verified: Jul 2026
First submitted: 1 Aug 2008
Last updated: 8 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

All Partial Edentulism trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions
ClinicalTrials.gov ID: NCT00728884
Acronym / sponsor ID: PrevailMulti / 2406
Conditions: Partial Edentulism
Keywords: dental implants, Certain Prevail, multicenter, clinical study, partial edentulism, total edentulism, platform switching, single stage
Study type: Observational
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: ZimVieIndustry (pharma, biotech, devices)
Study start: 6 Sep 2005 (actual)
Primary completion: 3 Feb 2011 (actual)
Study completion: 7 Jul 2011 (actual)
First posted: 6 Aug 2008 (estimated)
Results: Posted 17 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: These will be patients who are otherwise seeking dental implant therapy and belong to the study centers' standard patient population.

Key inclusion criteria (6 listed)

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:
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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Osseous Integration
Time frame: 2 years

Results and safety

Results posted to the registry on 17 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Certain Prevail Implants	161	161

Primary outcome: Osseous Integration

Time frame: 2 years. Number. Unit: participants

Measure	Certain Prevail Implants n = 161
Value	145

Population analysed: total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.

Adverse events

Time frame: Adverse event reports are collected from implant placement surgery until final follow up visit, 2 year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Certain Prevail Implants	0 of 161 (0%)	7 of 161 (4.3%)	0 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Partial Edentulism

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin Lorenzoni, DMD, MD, PhD principal investigator

MEDIZINISCHE UNIVERSITAT GRAZ

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Partial Edentulism, run by ZimVie at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Osseous Integration (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.