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

Giacomo Fabbri, Tristan Staas, Istvan Urban, Giacomo Fabbri, Tristan Staas, Istvan Urban

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.

Conflict of interest statement

G. Fabbri, T. Staas, and I. Urban report grants from Nobel Biocare Services AG during the conduct of the study.

Figures

Figure 1
Figure 1
Osteotomy formation protocol. Implant placement follows a two-step site preparation in cases where the osseoshaping instrument can be fully seated without exceeding the torque of 40 Ncm (left panel). If the instrument cannot be seated, the osteotomy is further enlarged using the dense bone–optimized osseoshaping instrument using a torque of up to 40 Ncm (right panel). If needed, the dense bone drill is used (not shown).
Figure 2
Figure 2
Data collection flow. EC, ethical committee.
Figure 3
Figure 3
Sample clinical cases from the study. (a–h) A 44-year-old female patient was treated with a single implant to replace a failing maxillary incisor at FDI (Federation Dentaire Internationale) position 21 (a,b). The 13 mm long implant was inserted with the final insertion torque of 57 Ncm with a flapless approach, connected to an On1 base (0.3 mm NP (narrow platform)), and loaded immediately (c,d). The final prosthesis was delivered 2 months later (e,f). Note the stabilization of the marginal bone levels and the excellent soft tissue response at the 1-year follow-up (g,h). (i–o) A 31-year-old female patient with missing and failing dentition in the maxilla (i,j) was treated with 6 study implants to support a full-arch prosthesis (k–m). Implants were inserted at FDI positions 13 (healed site), 15 (healed site), 17 (extraction site), 23 (extraction site), 25 (healed site), and 27 (extraction site). Implant length and final insertion torque were 11 mm and 50 Ncm, 11 mm and 50 Ncm, 13 mm and 30 Ncm, 11 mm and 40 Ncm, 11 mm and 50 Ncm, and 13 mm and 40 Ncm. The implants were connected to multi-unit abutments and loaded immediately. The final prosthesis was delivered 5 months later. Note the excellent soft tissue recovery visible at 2 months post-implant insertion (n) and the stable marginal bone levels at the 1-year follow-up (o).
Figure 4
Figure 4
Correlation between the torque of the osseoshaping instrument and the final implant insertion torque.

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