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The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoSpeed EV | Experimental | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
|
| OsseoSpeed TX | Active Comparator | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed EV | Device | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level Change After 1 Year in Use. | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. | Evaluated at implant loading and at the 1 year follow-up after implant loading. |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level Change After 5 Years in Use. | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 5 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clark M Stanford, Prof | University of Illinois at Chicago, College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dows Institute for Dental Research, University of Iowa, College of Dentistry | Iowa City | Iowa | 52242-1010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27447160 | Result | Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed EV | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
| FG001 | OsseoSpeed TX | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment to 1 Year Follow-up |
|
| ||||||||||||||||||
| 1 Year Follow-up to 5 Year Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed EV | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
| BG001 | OsseoSpeed TX | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 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 |
| 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 Change After 1 Year in Use. | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. | In the EV group, 55 subjects (73 implants) completed the 1 year follow-up visit. In the TX group, 60 subjects (84 implants) completed the 1 year follow-up visit. Three of the radiographs were not possible to evaluate, giving an overall number of 59 subjects (81 implants) as basis for the analysis of marginal bone level change. | Posted | Mean | Standard Deviation | Millimeter | Evaluated at implant loading and at the 1 year follow-up after implant loading. | Implants | Implants |
|
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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 EV | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis flare-up | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Affairs | DENTSPLY Implants | +46313763500 | ClinicalResearchMolndal@dentsplysirona.com |
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| OsseoSpeed TX | Device | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm |
|
| Evaluated from implant loading to the 5 years follow-up after implant loading. |
| University Hospital Ghent, Dental School Department Periodontology |
| Ghent |
| 9000 |
| Belgium |
| Dep. of Prosthodontics, Goethe University | Frankfurt am Main | 605 90 | Germany |
| Dental private practice, Denis Cecchinato | Padova | 351 25 | Italy |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
| OG001 | OsseoSpeed TX | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm |
|
|
| Secondary | Marginal Bone Level Change After 5 Years in Use. | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 5 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). | In the EV group, 40 subjects (52 implants) completed the 5-year follow-up visit. In the TX group, 45 subjects (64 implants) completed the 5-year follow-up visit. | Posted | Mean | Standard Deviation | Millimeter | Evaluated from implant loading to the 5 years follow-up after implant loading. | Implants | Implants |
|
|
|
| 13 |
| 59 |
| 0 |
| 59 |
| EG001 | OsseoSpeed TX | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm | 13 | 61 | 0 | 61 |
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection causing swelling and difficulties swallowing | Infections and infestations | Systematic Assessment |
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| Prostate cancer | Renal and urinary disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Abdominal aortic aneurysm | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Breast cancer | Reproductive system and breast disorders | Systematic Assessment |
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| Onset of Diabetes | Endocrine disorders | Systematic Assessment |
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| Hip surgergy | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hospitalisation due to surgery |
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| Torn retina | Eye disorders | Systematic Assessment |
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| Cyst | Gastrointestinal disorders | Systematic Assessment |
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| Hernia neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cancer of oesophagus | Gastrointestinal disorders | Systematic Assessment |
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| Fibia fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Colon cancer | Gastrointestinal disorders | Systematic Assessment |
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| High bloodpressure | General disorders | Systematic Assessment |
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| Insertion of cardiac stents | Cardiac disorders | Systematic Assessment |
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| Premature ventricular contractions (PVC) | Cardiac disorders | Systematic Assessment |
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| Death due to cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
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| Thumb lost in accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Aortic valve replacement surgery | Cardiac disorders | Systematic Assessment |
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