Performance Evaluation of FullCeram Implants in Single Tooth Gaps

Status Completed

Clinical Trial Summary

- Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone - The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year

Clinical Trial Description

This is a prospective, open label, single arm, multicenter study. The total study duration for each patient was prolonged to 10 years follow-up. It is acceptable to have the visit performed up to 6 month after the aspired date. The primary study parameter will be analyzed as soon as every patient passed visit 6 (annual follow-up visit, 12 month +/- 4 weeks). Implants will be placed transmucosally and will be protected by a thermoplastic splint for healing. A provisional prosthesis will be placed (out of occlusion) 12-14 weeks post implant placement. The final crown will be done between study week 24 and 28. Implant survival, implant success, bone loss, periodontal parameters and adverse events will be assessed in the follow-up visits. In total 10 visits are scheduled in this study. The investigational device: Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm. This is a CE marked product. Three centres in Germany are participating. The study and any amendments will be performed as far as possible according to ISO 14155 (Second Edition, 2011-02-01) and conform to the Declaration of Helsinki (last revised Seoul 2008) and local legal and regulatory requirements. ;

Study Design

Related Conditions & MeSH terms

Tooth Loss

Clinical Trial Details

NCT number	NCT02163395
Study type	Interventional
Source	Institut Straumann AG
Contact
Status	Completed
Phase	N/A
Start date	October 2011
Completion date	November 21, 2023

View Details

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