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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.
This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osseotite Certain Prevail | Active Comparator | Dental implant with lateralized design |
|
| Osseotite Certain | Placebo Comparator | Dental implant without the lateralized design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osseotite Certain 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 | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Friedmann, DMD | Charite- Zentrum fur Zahnmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite- Universitatsmedizin Berlin | Berlin | D-10117 | Germany |
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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.
A minimum of 100 patients were enrolled across all participating centers, with enrollment beginning in January 2005. Enrollment period remained open until April 2006. Three participating sites were Universities and seven 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 expanded, lateralized design at coronal portion |
| 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, 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 | 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 represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage. | Posted | Mean | Standard Error | millimeters | 1 year | implants | implants |
|
Adverse event reporting is collected from day of the study to present, currently 4 years study duration.
Adverse event data is collected by patient questionaire and visual inspection (assessment) of patient's mouth during 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 implant integration | Surgical and medical procedures | MedDRA 12.0 | 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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| Osseotite Certain | Device | Dental implant without the lateralized design |
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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 expanded, lateralized design at coronal portion
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion |
|
|
| Secondary | Osseous Integration | Not Posted | 4 years | Participants |
| 0 |
| 52 |
| 4 |
| 52 |
| EG001 | Osseotite Certain Implant | Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion | 0 | 50 | 19 | 50 |
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