A Retrospective Observational Study Assessing the Clinical Outcomes of a Novel Implant System with Low-Speed Site Preparation Protocol and Tri-Oval Implant Geometry

J Clin Med. 2022 Aug 18;11(16):4859. doi: 10.3390/jcm11164859.

Abstract

A novel, biologically friendly implant concept system introduces low-speed (50 rpm) site preparation instruments used without irrigation and a tri-oval, tapered implant designed to reduce stress on cortical bone without sacrificing mechanical stability. This retrospective, observational, multicenter study (clinicaltrials.gov NCT04736771) collected data from consecutive patients treated with at least one novel concept system implant to evaluate clinical outcomes after 1 year in function. The primary endpoint was a marginal bone level change (MBLC) from loading to 1 year, and secondary endpoints included implant survival and clinician feedback. Ninety-five patients (54 women and 41 men, mean age: 58 ± 12 years) were treated with 165 implants. For 94.5% of implants, site preparation was performed in two steps. The mean follow-up from implant insertion was 1.8 ± 0.2 years. Mean MBLC from implant loading to 1-year follow-up was +0.15 ± 0.85 mm (n = 124 implants). At the last follow-up, the implant survival rate was 98.0%. Clinician satisfaction with the novel concept system was high. The novel concept system offers an easy-to-use implant placement protocol, with most implants placed using two steps. The minimal bone remodeling and high survival rate observed across a variety of indications and treatment protocols demonstrate broad versatility and confirm the clinical benefits of this biologically friendly innovation.

Keywords: bone remodeling; implant site preparation; implant survival; tri-oval implant.

Associated data

  • ClinicalTrials.gov/NCT04736771