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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 mandible 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ | Device | OsseoSpeed™, all dimensions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. | At 5 year follow-up |
| Implant Stability | Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. | At 1 year follow-up |
| Marginal Bone Adaptation | Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss. | At 5 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edwin A McGlumphy, D.D.S. | The Ohio State University, College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University, College of Dentistry | Columbus | Ohio | 43210-1241 | United States | ||
| University of Washington, Dept. of Restorative Dentistry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22111584 | Result | Schliephake H, Rodiger M, Phillips K, McGlumphy EA, Chacon GE, Larsen P. Early loading of surface modified implants in the posterior mandible - 5 year results of an open prospective non-controlled study. J Clin Periodontol. 2012 Feb;39(2):188-95. doi: 10.1111/j.1600-051X.2011.01816.x. Epub 2011 Nov 23. |
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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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| Seattle |
| Washington |
| 98195 |
| United States |
| Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie | Göttingen | 37075 | 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 (134 implants in 44 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 |
|
| 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 |
| |||||||||||||||||||||||
| 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 will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be 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 (134 implants in 44 patients). | Posted | Number | Percentage of implants | At 5 year follow-up | Implants | Participants |
|
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| ||||||||||||||||||||||||||
| Primary | Implant Stability | Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. | Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis. | Posted | Mean | Standard Deviation | ISQ | At 1 year follow-up | Implants | Participants |
|
| ||||||||||||||||||||||||||
| Primary | Marginal Bone Adaptation | Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss. | Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis. | Posted | Mean | Standard Deviation | Millimeter | 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. | 17 | 45 | 0 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| KIDNEY ABCESS | Renal and urinary disorders |
| |||
| LOWER LUMBAR PAIN | Musculoskeletal and connective tissue disorders |
| |||
| AORTIC ANEURYSM | Vascular disorders |
| |||
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders |
| |||
| HEART ATTACK | Cardiac disorders |
| |||
| INTESTINAL PAIN | Gastrointestinal disorders |
| |||
| PT HAD MRI, CT SCAN + COLON OSCOPY DUE TO PAIN ON R ABDOMEN | Investigations |
| |||
| BACTERIAL LUNG INFECTION LED TO COLLAPSED LUNG | Respiratory, thoracic and mediastinal disorders |
| |||
| FLUID MASS REMOVED FROM LUNG AFTER INFECTION CLEARED | Surgical and medical procedures |
| |||
| HYSTERECTOMY | Surgical and medical procedures |
| |||
| HEART SURGERY (4 BYPASSES) | Surgical and medical procedures |
| |||
| TOXAEMIA AT RIGHT FOOT | Infections and infestations |
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| INJECTIONS BECAUSE OF PAIN IN THE LUMBAR SPINE | Surgical and medical procedures |
| |||
| OPERATION, SECOND STENT | Surgical and medical procedures |
| |||
| CLEANSING OF FRONTAL SINUS | Surgical and medical procedures |
| |||
| CYSTECTOMIA, ABLATION OF WISDOM TEETH | Surgical and medical procedures |
|
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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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