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.
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
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
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- 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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anton Friedmann, DMD, Principal investigator, Charite- Zentrum fur Zahnmedizin
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