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To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed TX | Device | OsseoSpeedTM TX implants of lengths 6-17 mm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level | Marginal Bone Level will be determined from radiographs and expressed as the difference 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 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline). | One year after loading |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability | Implant stability will be evaluated clinically/manually (recorded as stable yes/no) | At implant placement (inclusion) (day 1) |
| Implant stability | Implant stability will be evaluated using Resonance Frequency Analysis (RFA) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl-Johan Ivanoff, DDS, PhD | Colosseumkliniken Mölndal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialisttandvården, Hallands sjukhus | Halmstad | Sweden | ||||
| Avd. för Parodontologi / Avd. för Oral Protetik, Odontologiska Institutionen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33666125 | Derived | Ivanoff CJ, Lindhe J, Ellner S, Johansson KJ, Abrahamsson P. An open, randomised, multi-centre study, comparing straight and tapered apex implants design, in partially and totally edentulous maxillae. Acta Odontol Scand. 2021 Oct;79(7):492-498. doi: 10.1080/00016357.2021.1894352. Epub 2021 Mar 5. |
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| OsseoSpeed |
| Device |
OsseoSpeedTM implants of lengths 6-17 mm |
|
| At implant placement (inclusion) (day 1) |
| Implant stability | Implant stability will be evaluated clinically/manually (recorded as stable yes/no) | At implant loading (10-12 weeks after implant placement) |
| Implant survival | Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading. | One year after loading |
| Jönköping |
| Sweden |
| Specialist- och sjukhustandvården | Kalmar | Sweden |
| Centrum för Oral Rehablilitering | Linköping | 581 85 | Sweden |
| Colossseumkliniken Mölndal | Mölndal | 431 30 | Sweden |
| Käkkirurgiska kliniken / Protetikkliniken | Örebro | 701 85 | Sweden |
| Käkcentrum, Södersjukhuset | Stockholm | 118 83 | Sweden |
| Specialisttandvården, S:t Eriks Sjukhus | Stockholm | Sweden |
| Käkkirurgiska kliniken NÄL / Specialistcentrum Uddevalla sjukhus | Trollhättan | 431 85 | Sweden |
| Käkkirurgiska Kliniken/Protetikkliniken | Umeå | 901 87 | Sweden |
| Parodontologi kliniken och Protetik- och Bettfysiologiska kliniken | Vaxjo | 352 31 | Sweden |