Partial EdentulismFireballNCT00728962
A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.
An observational study of Partial Edentulism and Tooth Disease, run by ZimVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism, Tooth Disease
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Oct 2009
- 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 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: A Prospective, Observational Study of Osseotite Certain IOL (Immediate Occlusal Loading) Implants in Immediate Occlusal Loading of Short Span Fixed Restorations
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.
- Conditions
- Partial Edentulism, Tooth Disease
- Keywords
- dental implants, Osseotite Certain Prevail, multicenter, observational, clinical study, partial edentulism, single stage, immediate occlusal loading, crestal bone level, short fixed bridge
- Medical subject headings
- Tooth Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Crestal Bone Regression
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startMar 2005
- Primary completionMay 2006
- Study completionOct 2009
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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hessam Nowzari, DDS, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728962
- Sponsor's protocol ID
- 2208
- Acronym
- Fireball
- 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
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, Observational Study of Osseotite Certain IOL (Immediate Occlusal Loading) Implants in Immediate Occlusal Loading of Short Span Fixed Restorations
- ClinicalTrials.gov ID
- NCT00728962
- Acronym / sponsor ID
- Fireball / 2208
- Conditions
- Partial Edentulism, Tooth Disease
- Keywords
- dental implants, Osseotite Certain Prevail, multicenter, observational, clinical study, partial edentulism, single stage, immediate occlusal loading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Posted 5 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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 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
Key exclusion criteria (10 listed)
- 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
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
Patients With Implants Achieving Osseous Integration
Time frame: 1 year
Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.
1 secondary outcome
Crestal Bone Regression
Time frame: four years
Results and safety
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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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.
Hessam Nowzari, DDS principal investigator
University of Southern California
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 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 6 inclusion and 10 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 5 Feb 2010). 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?
Patients With Implants Achieving Osseous Integration (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.