Partial Edentulism Clinical Trial
— CliffhangerOfficial title:
A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone
NCT number | NCT00728754 |
Other study ID # | 2301 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2005 |
Est. completion date | April 2011 |
Verified date | March 2022 |
Source | ZimVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | April 2011 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
ZimVie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Secondary | Osseous Integration | four years |
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