Partial EdentulismCliffhangerNCT00728754

A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.

A study testing Dental implant Osseotite Prevail and Dental implant Osseotite in people with Partial Edentulism and Tooth Disease, run by ZimVie at 1 site in United States.

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 will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version 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… 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?: Dental implant Osseotite Prevail and Dental implant Osseotite
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Mar 2005to Apr 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 condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers 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 visits

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 a 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.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version 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 a similar but non-lateralized Osseotite Certain implant.

Read the detailed description

This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.

Conditions: Partial Edentulism, Tooth Disease
Being tested: Dental implant Osseotite Prevail, Dental implant Osseotite
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.

Dental implant Osseotite PrevailDevice
Also called Osseotite, Prevail
Root form titanium dental implant
Dental implant OsseotiteDevice
Also called Osseotite
root form titanium dental implant

Study groups in NCT00728754
Study group	Role	What they receive
Dental implant Osseotite Prevail	Experimental	Dental implant with lateralized design Receives: Device: Dental implant Osseotite Prevail
Dental implant Osseotite	Active comparator	Dental implant without the lateralized design Receives: Device: Dental implant Osseotite

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: four years

Timeline

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

Mar 2005Apr 2011

First posted6 Aug 2008 (estimated)
Study startMar 2005
Primary completionJul 2007
Study completionApr 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: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00728754
Sponsor's protocol ID: 2301x
Acronym: Cliffhanger
Status last verified: Mar 2022
First submitted: 1 Aug 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 Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone
ClinicalTrials.gov ID: NCT00728754
Acronym / sponsor ID: Cliffhanger / 2301x
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: 61 participants (actual)
Lead sponsor: ZimVieIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Jul 2007 (actual)
Study completion: Apr 2011 (actual)
First posted: 6 Aug 2008 (estimated)
Results: Posted 17 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 will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version 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
Dental implant Osseotite Prevail	Experimental	Device: Dental implant Osseotite PrevailDental implant with lateralized design
Dental implant Osseotite	Active comparator	Device: Dental implant OsseotiteDental 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 condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers 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 visits

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.

Interventions

Intervention	Type	Arms
Dental implant Osseotite PrevailAlso: Osseotite, PrevailRoot form titanium dental implant	Device	Dental implant Osseotite Prevail
Dental implant OsseotiteAlso: Osseotiteroot form titanium dental implant	Device	Dental implant Osseotite

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: four years

Results and safety

Results posted to the registry on 17 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	29	29
Osseotite Certain Implant	32	32

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 = 24	Osseotite Certain Implant n = 28
Value	-0.7440 (0.1881)	-0.8445 (0.1439)

Population analysed: population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events are collected and reported from day 1 of the study to present, 4 years of study duration to date.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Osseotite Certain Prevail Implant	0 of 29 (0%)	5 of 29 (17.2%)	Not reported
Osseotite Certain Implant	0 of 32 (0%)	5 of 32 (15.6%)	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

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Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
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Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
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Active, not recruitingObservational study
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Recruiting
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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.

Harold Baumgarten, DMD principal investigator

University of Pennsylvania

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

Questions about this trial

What is this clinical trial studying?

A study testing Dental implant Osseotite Prevail and Dental implant Osseotite in people with Partial Edentulism and Tooth Disease, run by ZimVie at 1 site in United States.

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 United States. 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 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 NCT00728754.

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.