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A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The implant is a two piece design to allow both one- and two- stage surgical procedures. The entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to promote and maintain primary stability, which later on leads to secondary stability.
NR CC implants are used as the foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to an entire arch of bridgework. The implants are also intended as retentive elements for overdenture applications.
The present study is designed to evaluate, after the insertion of the NR CC, the marginal bone levels and bone remodelling at the implant sites over various time points up to 5 years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are as well evaluated together with implant success and survival rate.
Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this clinical investigation will demonstrate clinical safety and reliability of the NR CC using different treatment options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NR CC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NR CC | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone levels and bone remodeling at the implant sites | The parameter will be measured at 1, 2, 3 and 5 years after implant insertion | yearly, from baseline up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Soft Tissue Index | The parameter will be measured at 1, 2, 3 and 5 years after implant insertion | yearly, from baseline up to 5 years |
| Pink Aesthetic Score (PES) | The parameter will be measured at 1, 2, 3 and 5 years after implant insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27864641 | Derived | Fugl A, Zechner W, Pozzi A, Heydecke G, Mirzakhanian C, Behneke N, Behneke A, Baer RA, Nolken R, Gottesman E, Colic S. An open prospective single cohort multicenter study evaluating the novel, tapered, conical connection implants supporting single crowns in the anterior and premolar maxilla: interim 1-year results. Clin Oral Investig. 2017 Jul;21(6):2133-2142. doi: 10.1007/s00784-016-2003-0. Epub 2016 Nov 18. |
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| yearly, from baseline up to 5 years |
| Bleeding on Probing (BoP) | The parameter will be measured at 1, 2, 3 and 5 years after implant insertion | yearly, from baseline up to 5 years |
| Patient satisfaction | Patient satisfaction will be assessed at 1, 2, 3 and 5 years after implant insertion | yearly, from baseline up to 5 years |
| success and survival rates of implants. | Success and survival rate will be assessed at 1, 2, 3 and 5 years after implant insertion | yearly, from baseline up to 5 years |