N/A
Completed N=102
A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases
Partial edentulism · Tooth Disease
Source: ClinicalTrials.gov NCT00723944 ↗
Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit — -0.7705; -0.6648 millimeters
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.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit |
-0.7705; -0.6648 | — |
| SECONDARY Osseous Integration |
— | — |
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 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
Exclusion Criteria
- 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
- 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 (NCT00723944). 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. Informational only — not medical advice.