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The purpose of this study is to assess the outcome of a new bone level tapered implant when inserted either following an immediate placement protocol or an early placement approach and restored with single crowns out of two different ceramic materials adhesively cemented on a titanium bonding base.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant placement | Experimental | Implant is placed immediately after tooth extraction. |
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| Delayed implant placement | Active Comparator | Implant is placed 8 weeks after tooth extraction. |
|
| Lithium disilicate crown | Experimental | Crown out of Lithiumdisilicate is inserted onto the implant. |
|
| Zirconia Crown | Active Comparator | Crown out of Zirconia is inserted onto the implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timepoint of Implant placement of Bonelevel tapered implants | Procedure | Implant surgery on different time points |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival | Survival of the implant | 5 years |
| Survival of the reconstructions | Survival of prosthetic reconstruction | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mesial and distal bone levels | Peri-implant bone level changes | 5 years |
| ISQ values | Measurement of ISQ values during implant surgery and at insertion of crown |
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Inclusion Criteria:
Subjects must require extraction and replacement of a tooth in the maxillary or mandibular anterior or premolar region with an implant reconstruction.
Exclusion Criteria:
Patients with a high lip line / smile line
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In the first phase, participants are randomized to receive implants either immediately or 8 weeks after tooth extraction. In a second phase, participants receive either a restoration out of one material or another, this also being randomized.
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| Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia | Combination Product | Tooth restoration with a certain material |
|
| 3 months |
| Soft tissue volume | Intra-oral digital scans with volumetric software will be used for the soft tissue volume measurements. | 5 years |
| Technical and biological outcomes of the restorations | Presence of fractures/chipping, retention loss, screw loosening | 5 years |
| Recording the need of GBR procedures | Need of GBR procedure or not during surgery | 8 weeks |
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| C028541 | zirconium oxide |
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