A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases. (Cliffhanger)
This study has been completed.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00728754
First received: August 1, 2008
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Partial Edentulism Tooth Disease |
Device: Dental implant Osseotite Prevail Device: Dental implant Osseotite |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Osseous Integration [ Time Frame: four years ] [ Designated as safety issue: Yes ]
| Enrollment: | 61 |
| Study Start Date: | March 2005 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dental implant Osseotite Prevail
Dental implant with lateralized design
|
Device: Dental implant Osseotite Prevail
Root form titanium dental implant
Other Names:
|
|
Active Comparator: Dental implant Osseotite
Dental implant without the lateralized design
|
Device: Dental implant Osseotite
root form titanium dental implant
Other Name: Osseotite
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728754
Locations
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Biomet, Inc.
Investigators
| Principal Investigator: | Harold Baumgarten, DMD | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00728754 History of Changes |
| Other Study ID Numbers: | 2301 |
| Study First Received: | August 1, 2008 |
| Results First Received: | June 26, 2009 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biomet, Inc.:
|
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 |
Additional relevant MeSH terms:
|
Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013