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Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.
This is a randomized, controlled, multicenter study to assess and compare implant stability of Trabecular Metal (TM) dental implants and Tapered Screw-Vent (TSV) implants during the early stages of healing i.e. 21 +/- 2 days and 42+/- 2 days, as well as their short term clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapered Screw-vent implants (TSV) | Active Comparator | TSV implants to replace missing tooth/teeth |
|
| Trabecular Metal dental implants (TM) | Experimental | TM dental implants to replace missing tooth/teeth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabecular metal dental implants (TM) | Device | Patients receive TM dental implants in this arm. The early stability is measured and compared to the stability of the TSV implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability | Measure of Implant Stability Quotient immediately post implantation | 3-18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal bone level change | Measurement of bone level surrounding implant | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Wagner | Universitatsbedizin Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Regensburg | Regensburg | Bavaria | 93053 | Germany | ||
| Heinrich Heine Universitat Dusseldorf |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| Tapered screw-vent implants (TSV) | Device | Patients receive TSV dental implants in this arm. The early stability is measured and compared to the stability of the TM implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits. |
|
| Düsseldorf |
| Nordhein-Westfalen |
| 40225 |
| Germany |
| Universitatsmedizin Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |