N/A
N=61
A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.
Partial Edentulism · Tooth Disease
Bottom Line
View on ClinicalTrials.gov: NCT00728754 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit — -0.7440; -0.8445 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dental implant Osseotite Prevail (Device); Dental implant Osseotite (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZimVie
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit |
-0.7440; -0.8445 | — |
| SECONDARY Osseous Integration |
— | — |
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 same as for a similar but non-lateralized Osseotite Certain implant.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00728754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.