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The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASTRA TECH Implant System; Fixture ST | Experimental | Ø 4.5 cm in lengths 9-13 mm |
|
| Biomet 3i; Osseotite® Implants | Experimental | Ø 4.0 cm in lengths 8.5-13 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. | Device |
| ||
| 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level Changes | Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss. | 3 years after implant placement (baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis P Tarnow, D.D.S. Prof. | Dept. of Implant Dentistry, New York University (to March 2011) | Principal Investigator |
| Stuart Froum, Dr | Dept. of Implant Dentistry, New York University (from March 2011) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Implant Dentistry, New York University | New York | New York | 10010 | United States | ||
| Dept. of Prosthodontics, School of Dentistry, University of North Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | ASTRA TECH Implant System; Fixture ST | Ø 4.5 cm in lengths 9-13 mm ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. |
| FG001 | Biomet 3i; Osseotite® Implants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
|
| Chapel Hill |
| North Carolina |
| 27599-7450 |
| United States |
Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ASTRA TECH Implant System; Fixture ST | Ø 4.5 cm in lengths 9-13 mm ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. |
| BG001 | Biomet 3i; Osseotite® Implants | Ø 4.0 cm in lengths 8.5-13 mm 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Marginal Bone Level Changes | Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss. | Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis. | Posted | Mean | Standard Deviation | millimeter | 3 years after implant placement (baseline) | Implants | Participants |
|
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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 | ASTRA TECH Implant System; Fixture ST | Ø 4.5 cm in lengths 9-13 mm ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. | 1 | 18 | 0 | 18 | ||
| EG001 | Biomet 3i; Osseotite® Implants | Ø 4.0 cm in lengths 8.5-13 mm 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm | 1 | 18 | 0 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Advanced breast cancer | Reproductive system and breast disorders |
| |||
| Prostate cancer | Reproductive system and breast disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Clinical Research | DENTSPLY Implants | +46313763500 | clinicalresearchmolndal@dentsply.com |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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| Male |
|