Safety and effectiveness of the N1 concept system: real-world data with 1-year follow-up
Clinical research evaluating a novel implant system and drill protocol
Successful osseointegration is influenced by implant characteristics such as geometry and surface, as well as implant site preparation technique. A novel implant system (Nobel Biocare N1 TM) contains new instruments for osteotomy preparation (OsseoShaper TM) at low speed with no irrigation, a trioval implant design with new implant surface as well as dedicated prosthetic components.
A multicenter retrospective investigation aimed to evaluate the clinical performance of the Nobel Biocare N1 system after 1 year of function. The primary endpoint was to assess the marginal bone level change from loading to 12 months thereafter based on matched readable radiographs.
Of 95 patients (165 implants) included in this study, 81 (145 implants) had reached the 12-month follow-up. The indications ranged from single tooth (78 implants), over partially edentulous (43 implants) to fully edentulous (44 implants) situations. The bone quality at the recipient sites was rated as very dense (14 sites), dense (16 sites), soft (88 sites) and very soft (38 sites). The implant system was used in a variety of site types including healed sites and fresh extraction sockets, and loaded in immediate, early, delayed and conventional loading protocols.
165 implants were placed in 95 patients
Almost all implants (97.5%) were placed after the use of the OsseoShaper instrument
Survival rate after 12 months was 98%
Mean marginal bone gain of +0.15 mm 12 months from implant loading
The study presented here is the first clinical study documenting this novel implant system. The Nobel Biocare N1 implant system supports successful osseintegration of implants while simplifying the osteotomy procedure. The system offers an easy-to-use implant placement protocol with most implants placed after only two steps.
This study was supported by Nobel Biocare (grant T-193).
Presented at the 30th Annual Scientific Meeting of the European Association of Osseointegration (EAO Digital Days), 12-14 October 2021, Oral Communication. Video republished by the Foundation for Oral Rehabilitation with permission of the author.