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Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.
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The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.
Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixture MicroThread (Micro-Macro) | Device | Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival | Continuously during 5,5 years after implant placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Sunzel, Dr | Käkkirurgiska kliniken, Universitetssjukhuset MAS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Medical Center, School of Dentistry | New Orleans | Louisiana | 70119-2799 | United States | ||
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| Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität |
| Heidelberg |
| Germany |
| Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia | Madrid | 28040 | Spain |
| Käkkirurgiska kliniken, Universitetssjukhuset MAS | Malmö | 205 02 | Sweden |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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