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This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance.
Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).
This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Osseous Integration | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal Bone Resorption | Crestal bone level measures- changes from baseline to last study visit | four years |
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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:
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:
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These will be patients who are otherwise seeking dental implant therapy and belong to the study centers' standard patient population.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Lorenzoni, DMD, MD, PhD | MEDIZINISCHE UNIVERSITAT GRAZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde | Graz | 8036 | Austria |
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Pre-treatment included a screening visit (enroll those meeting all inclusion criteria),signing informed consent, and per-surgical data collection. Patients are then scheduled for implant placement surgery.
Up to 200 patients will be enrolled across all participating centers, with enrollment efforts beginning in August 2005. Enrollment period remained until February 2007. Ten participating sites are private practices and two are Universities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Certain Prevail Implants | Osseotite surfaced implants with internal connection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Implant Placement Surgery |
| |||||||||||||
| Permanent Prosthesis Placement |
| |||||||||||||
| One Year Post Placement Follow-up |
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| Two Year Post Placement Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Certain Prevail Implants | Osseotite surfaced implants with internal connection |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Osseous Integration | total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis. | Posted | Number | participants | one year |
|
|
Adverse event reports are collected from day to present, 3 years study duration to date.
Adverse event data is collected during each study event visit the patient is seen for.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Certain Prevail Implants | Osseotite surfaced implants with internal connection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Biomet 3i LLC | 5617766722 | cristina.matthews@biomet.com |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Crestal Bone Resorption | Crestal bone level measures- changes from baseline to last study visit | Not Posted | No | four years | Participants |
| 0 |
| 162 |
| 0 |
| 162 |
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