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

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.

Determinants of Temperature Development during Dental Implant Surgery

“…From a clinical perspective, the omission of cervical threads did not enhance esthetic performance as compared to a more traditional, round implant design [36]. Similarly, no major advantage with respect to marginal bone level change was described for implants with a tri-oval [37] or a triangular [38] design.…”

Customer Complaints as an Evaluation Tool Assessing the Performance and Clinical Suitability of Different Implant Design

“…Another problem is the definition of success criteria in clinical studies [3][4][5]. In a number of studies, only those implants that had reached at least the phase of the prosthetic treatment are counted as lost.…”

Management of bleeding during dental implant surgery using a novel implant with an abbreviated drilling protocol: A clinical report

“…Instead, the new protocol involves the use of a single drill (‘osseodirector’), an implant‐specific single‐use bone shaping instrument (‘osseoshaper’) followed by placement of the implant with a novel tri‐oval connection, which is co‐packaged with the bone shaping instrument. A short‐term retrospective study across numerous clinicians reported preliminary data on the successful use of the novel N1 System 7 . The authors reported minimal bone remodeling, a high implant survival rate, and improved clinician and patient satisfaction 7 .…”

“…A short‐term retrospective study across numerous clinicians reported preliminary data on the successful use of the novel N1 System 7 . The authors reported minimal bone remodeling, a high implant survival rate, and improved clinician and patient satisfaction 7 . The purpose of this clinical report was to describe the successful management of a male patient with a history of coagulopathy who was rehabilitated with complete arch fixed implant‐supported prostheses with immediate loading using the novel implant design and drilling protocol.…”