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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental implant Osseotite Prevail | Experimental | Dental implant with lateralized design |
|
| Dental implant Osseotite | Active Comparator | Dental implant without the lateralized design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant Osseotite Prevail | Device | Root form titanium dental implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Osseous Integration | four years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold Baumgarten, DMD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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Pre-treatment included a screening visit (enroll those meeting all inclusion criteria), signing informed consent, and pre-surgical data collection.Patients returned for implant placement surgery, followed by temporary prosthesis placement at 2 months.
Up to 120 patients were enrolled across all centers, with enrollment efforts beginning in February 2005. Enrollment period remained open until June 2006. Two participating sites were Universities and four were private practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Osseotite Certain Prevail Implant | Patients with dental implant with internal connection and expanded, lateralized design at coronal portion |
| FG001 | Osseotite Certain Implant | Patients with dental implant with internal connection and without the lateralized expanded platform design |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Implant Placement Surgery |
| |||||||||||||
| Permanent Prosthesis Placement |
| |||||||||||||
| One Year Post Placement Follow-up |
| |||||||||||||
| Two Year Post Placement Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Osseotite Certain Prevail Implant | Patients with dental implant with internal connection and expanded, lateralized design at coronal portion |
| BG001 | Osseotite Certain Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | 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. | population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis). | Posted | Mean | Standard Error | millimeters | 1 year | implants | implants |
|
Adverse events are collected and reported from day 1 of the study to present, 4 years of study duration to date.
Adverse event data is collected by patient questioning and visual examination of patient's mouth each study event visit.
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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 | Osseotite Certain Prevail Implant | Patients with dental implant with internal connection and expanded, lateralized design at coronal portion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of integration of implant | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Biomet 3i LLC | 5617766722 | cristina.matthews@biomet.com |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| Dental implant Osseotite | Device | root form titanium dental implant |
|
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Patients with dental implant with internal connection and without the lateralized expanded platform design
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Patients with dental implant with internal connection and without the lateralized expanded platform design |
|
|
| Secondary | Osseous Integration | Not Posted | four years | Participants |
| 0 |
| 29 |
| 5 |
| 29 |
| EG001 | Osseotite Certain Implant | Patients with dental implant with internal connection and without the lateralized expanded platform design | 0 | 32 | 5 | 32 |
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