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The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ | Device | OsseoSpeed™, all dimensions |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. | At 5 year follow-up |
| Implant Stability | Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability. | At 1 year follow-up |
| Marginal Bone Adaptation | 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 follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss. | At baseline (loading) and at 5 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James T Mellonig, D.D.S., M.S | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa, College of Dentistry, Dow's Institute for Dental Research | Iowa City | Iowa | 52242-1010 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed | Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| UTHSCSA |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Universitetsklinik Mainz, Klinik fur ZMK | Mainz | D-551 31 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed | Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Implant Survival Rate | An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. | Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period. | Posted | Number | percentage of implants | At 5 year follow-up | Implants | Participants |
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| Primary | Implant Stability | Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability. | Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis. | Posted | Mean | Standard Deviation | units on a scale | At 1 year follow-up | Implants | Participants |
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| Primary | Marginal Bone Adaptation | 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 follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss. | Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis. | Posted | Mean | Standard Deviation | Millimeter | At baseline (loading) and at 5 year follow-up | 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 | OsseoSpeed | Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm. | 3 | 47 | 0 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart attack | Cardiac disorders |
| |||
| Subdural hematoma | Vascular disorders |
| |||
| Blod clot in lower leg | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Operations | DENTSPLY Implants | +46313763500 |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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| Implants |
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| Implants |
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