Partial EdentulismRadioCityNCT00723944

A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

A study testing Osseotite Certain Prevail and Osseotite Certain in people with Partial Edentulism and Tooth Disease, run by ZimVie at 1 site in Germany.

Completed

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

Official record

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Trial summary

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Partial Edentulism, Tooth Disease
What is being tested?: Osseotite Certain Prevail and Osseotite Certain
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 1 siteGermany
Study dates: Feb 2005to May 2011
Phase: Interventional
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

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: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are allowed, but one interior crown may be a pontic
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 the implants
patients with more than 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

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 cantilevers and more than one pontic per bridge

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charite- Universitatsmedizin Berlin
Berlin, D-10117

Other trials in Germany

About this study

Official title: A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-span Fixed Bridge Cases for Preservation of Crestal Bone

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.

Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.

Read the detailed description

This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.

Conditions: Partial Edentulism, Tooth Disease
Being tested: Osseotite Certain Prevail, Osseotite Certain
Keywords: dental implants, Osseotite Certain Prevail, Lateralized, non-lateralized, Osseotite Certain, multicenter, randomized, clinical study, partial edentulism, single stage, early loading, crestal bone level, short fixed bridge
Medical subject headings: Tooth Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Osseotite Certain PrevailDevice
Also called Osseotite, Certain, Prevail
Root form titanium dental implant
Osseotite CertainDevice
Also called Osseotite, Certain
Dental implant without the lateralized design

Study groups in NCT00723944
Study group	Role	What they receive
Osseotite Certain Prevail	Active comparator	Dental implant with lateralized design Receives: Device: Osseotite Certain Prevail
Osseotite Certain	Placebo comparator	Dental implant without the lateralized design Receives: Device: Osseotite Certain

What is being measured

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

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.
Measured: 1 year

Secondary outcomes (1)

Osseous Integration
Measured: 4 years

Timeline

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

Feb 2005May 2011

First posted29 Jul 2008 (estimated)
Study startFeb 2005
Primary completionApr 2007
Study completionMay 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00723944
Sponsor's protocol ID: 2302
Acronym: RadioCity
Status last verified: Mar 2022
First submitted: 25 Jul 2008
Last updated: 28 Jul 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

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All Partial Edentulism trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-span Fixed Bridge Cases for Preservation of Crestal Bone
ClinicalTrials.gov ID: NCT00723944
Acronym / sponsor ID: RadioCity / 2302
Conditions: Partial Edentulism, Tooth Disease
Keywords: dental implants, Osseotite Certain Prevail, Lateralized, non-lateralized, Osseotite Certain, multicenter, randomized, clinical study
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: ZimVieIndustry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Apr 2007 (actual)
Study completion: May 2011 (actual)
First posted: 29 Jul 2008 (estimated)
Results: Posted 22 Nov 2011

Clinical summary

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

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Osseotite Certain Prevail	Active comparator	Device: Osseotite Certain PrevailDental implant with lateralized design
Osseotite Certain	Placebo comparator	Device: Osseotite CertainDental implant without the lateralized design

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 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: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are allowed, but one interior crown may be a pontic
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 the implants
patients with more than 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.

Interventions

Intervention	Type	Arms
Osseotite Certain PrevailAlso: Osseotite, Certain, PrevailRoot form titanium dental implant	Device	Osseotite Certain Prevail
Osseotite CertainAlso: Osseotite, CertainDental implant without the lateralized design	Device	Osseotite Certain

Primary outcome

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
Time frame: 1 year
Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.

1 secondary outcome

Osseous Integration
Time frame: 4 years

Results and safety

Results posted to the registry on 22 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Osseotite Certain Prevail Implant	52	52
Osseotite Certain Implant	50	50

Primary outcome: Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

Time frame: 1 year. Mean (Standard Error). Unit: millimeters

Measure	Osseotite Certain Prevail Implant n = 48	Osseotite Certain Implant n = 37
Value	-0.7705 (0.1567)	-0.6648 (.1158)

Population analysed: population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event reporting is collected from day of the study to present, currently 4 years study duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Osseotite Certain Prevail Implant	0 of 52 (0%)	4 of 52 (7.7%)	Not reported
Osseotite Certain Implant	0 of 50 (0%)	19 of 50 (38%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for 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
Recruiting
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Partial Edentulism, Dental Implant Placement

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.

Anton Friedmann, DMD principal investigator

Charite- Zentrum fur Zahnmedizin

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

Questions about this trial

What is this clinical trial studying?

A study testing Osseotite Certain Prevail and Osseotite Certain in people with Partial Edentulism and Tooth Disease, run by ZimVie at 1 site in Germany.

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 4 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 28 Jul 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 Germany. 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. Some participants in this study may receive a placebo. 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 22 Nov 2011). 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?

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit (time frame: 1 year). 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 NCT00723944.

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 28 Jul 2026.